June 2019

Regulatory Affairs
Certification
(Devices)
C A N D I D AT E G U I D E

RAPS.org/RAC
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CONTENTS
Welcome.........................................................................................................................................3
Introduction..............................................................................................................................................................................................................................3
Value of the RAC......................................................................................................................................................................................................................3
About Certification.................................................................................................................................................................................................................3

Preparing for the Exam..............................................................................................................4

RAC Examination Overview...............................................................................................................................................................................................4
Preparing for the Examination...........................................................................................................................................................................................4
Question Types.........................................................................................................................................................................................................................5
Computer-Based Testing.....................................................................................................................................................................................................5
Your Journey.............................................................................................................................................................................................................................5

Applying for the Examination..................................................................................................6

RAC Application Process.....................................................................................................................................................................................................6
Testing Windows and Application Deadlines...............................................................................................................................................................6
Eligibility Requirements.......................................................................................................................................................................................................6
General Application Instructions......................................................................................................................................................................................7
Submitting Payment...............................................................................................................................................................................................................8
Application Receipt Confirmation....................................................................................................................................................................................8
Application Audit.....................................................................................................................................................................................................................8
Incomplete Applications.......................................................................................................................................................................................................8
Application Rejection............................................................................................................................................................................................................8
Application Withdrawal/Cancellation and Refunds.................................................................................................................................................8
Transferring to Another Testing Cycle............................................................................................................................................................................9
Appeals Process.......................................................................................................................................................................................................................9
Nondiscrimination Policy.....................................................................................................................................................................................................9

Examination Scheduling......................................................................................................... 10
Scheduling Your Examination.......................................................................................................................................................................................... 10
Testing ...................................................................................................................................................................................................................................... 10
International Testing........................................................................................................................................................................................................... 10
Changing Your Examination Appointment After it Has Been Scheduled...................................................................................................... 10
Emergency Situations......................................................................................................................................................................................................... 11
Failure to Schedule an Examination or Appear for Your Examination Appointment............................................................................... 11
Special Accommodations for the Examination......................................................................................................................................................... 11

On Examination Day................................................................................................................ 12
What to Bring to the Testing Center............................................................................................................................................................................ 12
Items Prohibited at the Testing Center....................................................................................................................................................................... 12
Other Considerations......................................................................................................................................................................................................... 12
Cancellation Due to Inclement Weather.................................................................................................................................................................... 13
Examination Security and Confidentiality................................................................................................................................................................. 13
Termination of Examination Administration/Dismissal From the Testing Center..................................................................................... 13
Problems at the Testing Center...................................................................................................................................................................................... 13

After the Examination............................................................................................................ 14

Examination Scoring........................................................................................................................................................................................................... 14
Notification of Examination Results............................................................................................................................................................................. 14
RAC Recognition.................................................................................................................................................................................................................. 14
Use of the RAC Designation............................................................................................................................................................................................. 14
Retaking the Examination................................................................................................................................................................................................. 14
Release of Information....................................................................................................................................................................................................... 14

Recertify...................................................................................................................................... 15
Maintaining Your RAC Credential................................................................................................................................................................................. 15

Appendix A: RAC (Devices) Detailed Examination Content Outline ..................... 16

Appendix B: Special Accommodations Request............................................................. 19
Appendix C: Documentation of Disability-Related Needs......................................... 20
Appendix D: Code of Ethics................................................................................................... 21

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WELCOME
Introduction
Congratulations on your decision to pursue Regulatory Affairs Certification (RAC). We commend
your commitment to your career and the regulatory profession.

This guide contains information about:

• RAC examination eligibility requirements
• Guidelines for submitting an examination application
• Preparing for the examination
• How to schedule your examination and what to expect at the testing center
• What to expect after the examination

Regulatory Affairs Certification (RAC), is the only post-academic professional credential for reg-
ulatory professionals in the healthcare product sector. It is intended for individuals employed in
regulatory agencies, industry, consultancies and other settings involved with the regulation of
healthcare products. The RAC is a professional credential that denotes commitment to excellence,
pursuit of knowledge and career advancement. Success on the RAC examinations requires knowl-
edge of the appropriate regulations and the ability to think critically about the regulatory issues and
challenges that occur throughout the healthcare product lifecycle.

RAC-credentialed professionals are among the current and rising leaders

in the regulatory profession. To date, more than 8,500 individuals
have earned the RAC, some holding multiple credentials.

Value of the RAC

The RAC demonstrates to employers, clients and colleagues that a regulatory professional has the
essential knowledge, skills, critical thinking abilities and commitment to advancing professional
knowledge and abilities. As the demand for competent regulatory professionals increases globally,
RAC-credentialed professionals are well positioned to be effective team members and contributors
in every work setting. Recognition of the RAC continues to grow around the world and RAC-
credentialed professionals earn higher salaries than those who do not hold the credential.*

In RAPS’ 2018 Scope of Practice & Compensation survey for the Regulatory
Profession, RAC holders in North America reported earning an average of
18% more than their counterparts who do not hold the credential.*

*Based on data from the 2018 RAPS Scope of Practice & Compensation Survey of the Regulatory Profession

About Certification
The primary purpose of any professional certification program is to provide an independent
assessment of the knowledge, skills and/or competencies required for competent performance of
a professional role. This assessment is typically accomplished by the successful completion of an
examination.1

1
 efining Features of Quality Certification and Assessment-Based Certificate Programs. (2010) The Institute for
D
Credentialing Excellence.

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PREPARING FOR THE EXAM

RAC Examination Overview
Each examination is based on a survey of the scope of practice and specific roles and responsibilities
of regulatory professionals in the workplace with at least three years of regulatory experience. Each
examination is reviewed and revised annually and content is updated for the Spring exam cycle.
Examination content for RAC exam is based on regulations and guidelines in effect on December 31
of the year prior. So exams taken in 2019 will be based on regulations ‘on the books’ on December
31, 2018.

RAC (Devices)

• Knowledge of the full product development and lifecycle requirements for medical
devices, and IVDs.
Knowledge required • Knowledge of US FDA requirements (30%); European regulations and guidances from
and regulatory basis the European Commission and competent authorities (30%); and globally applicable
regulatory practices* (40%). (*IMDRF, WHO and ISO guidelines and standards).
• Critical thinking and analytical skills.

Preparing for the Examination

The RAC examinations are challenging, so it is important to develop a study plan to prepare for the
examination. Your plan should be based on your knowledge, experience and preferred approach to
learning. Here are some things to consider:

Review the examination content outline (see p. 16). The examination content outline contains the
content domains, competency statements and number of questions in each domain. Examination
questions are based on guidelines and regulations effective 31 December of the prior year.

Assess the scope and depth of your knowledge and experience. Use the test content outline as a
checklist and evaluate your areas of strength and weakness. This will help focus your study on the
areas you need most.

Build and implement your plan. Allow sufficient time to build your knowledge base in areas where
you have limited experience and to expand your knowledge in areas more familiar to you. Use refer-
ence materials to supplement your knowledge.

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Question Types
The examinations consist of 100 multiple-choice questions, answered in a two-hour time limit.
There are three question formats which may be used in the RAC Exams.

Recall Application Analysis

Recall questions ask for specific Application questions require Analysis questions may be
information, typically about relating specific knowledge to described as a small case or
regulations and guidance that a situation that may be encoun- example requiring the can-
are important aspects of the tered in the scope of practice of didate to read and assemble
regulatory process. These ques- a regulatory professional. information in order to identify
tions may relate to any stage of and evaluate various solutions.
product development and may
relate to regulations specific for
product types.

Computer-Based Testing
The RAC examinations are computer-based and administered only at testing centers selected and
confirmed by the testing vendor. RAC examinations will not be stored or accessible through the inter-
net and will not be offered at facilities that are not pre-selected and qualified for security measures.

Your Journey

PREPARE APPLY SCHEDULE TAKE EXAM RECERTIFY

Check the RAPS website at RAPS.org/rac/prepare for additional resources that may be helpful to
you. Some resources are free of charge and others are available for purchase. Resources are not
required to be RAPS produced.

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APPLYING FOR THE

EXAMINATION
RAC Application Process
You may apply for the RAC online or submit the printable application form available on the RAC
exam schedules webpage.

Testing Windows and Application Deadlines

Application Deadline Testing Window
24 September 2019 21 October–30 November 2019
27 February 2020 23 March–1 May 2020
18 June 2020 13 July–21 August 2020
8 October 2020 2 November–11 December 2020

Applications and payment must be received by 11:59 pm (US Eastern Time) on the application dead-
line dates listed above. Applications received after the deadline will not be processed.

Examination Fees
2019 Prices

• RAPS Member $475 (US)

• List $595 (US)

The RAPS member rate applies only if you are a member at the time you submit your application. If
you apply for RAPS membership prior to submitting an RAC application, please be sure you receive
confirmation of your RAPS membership before you submit your RAC application. If you apply for
RAPS membership after you submit an RAC application, RAPS will not refund the difference.

Get information about RAPS membership online at RAPS.org/join-raps.

Eligibility Requirements
To be eligible for the RAC examination you need to meet one of the following educational and pro-
fessional experience requirement combinations:

Baccalaureate or
Master’s degree and a Doctorate degree and
equivalent first university
minimum of two years a minimum of one year
degree and a minimum of
of regulatory or reg- of regulatory or reg-
three years of regulatory
ulatory-related work ulatory-related work
or regulatory-related
experience* experience*
work experience*

*Regulatory-related experience may include quality assurance, quality control, clinical research related to the approval of health
products or health product project management.

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General Application Instructions

Include your name on the application as it appears on your government-issued photo identification (ID).
If your name on your application does not match the government id, you will not be allowed to sit for
the exam at the testing venue.

Provide a valid e-mail address that will be maintained throughout your RAC application period. If
you choose to provide a work e-mail address, please keep in mind that any change in your employ-
ment during your application may mean you no longer have access to that e-mail account. email
address. All communications about your RAC examination, including information about scheduling
your examination and examination results, are electronic. Please contact the RAC program office
at certification@raps.org if there is any change in your email address after you have submitted your
application.

Complete the RAC examination application fully. As part of the application process, you must attest
to the following:

• I have read, understood and agree to comply with all policies outlined in the RAC Candidate
Guide.
• The information in my RAPS account is complete and accurate.
• I meet all eligibility requirements for the RAC exam, and I authorize RAPS to make any
inquiries deemed necessary to verify my credentials. I understand that false information
may be cause for denial of this application or loss of the RAC credential.
• I allow RAPS to use information from my application and from the examination for the pur-
pose of aggregate statistical analysis, provided that any personal information or identifiers
are removed.
• I understand and agree to the policies related to withdrawing from the examination, pre-
sented in the Candidate Guide.
• I acknowledge that I have read and understand the tenets outlined in the RAPS Code of
Ethics

Please see Appendix D for the Code of Ethics for Regulatory Professionals.
Incomplete applications will delay processing and may cause your application to be rejected if not
completed by the application deadline.

Submitting Payment
The correct payment must accompany your application. You may submit your application and pay-
ment in the following ways:

Payment type Application submission method

Credit card Apply online, by fax or postal mail to:
Regulatory Affairs Professionals Society
Attn: RAC Program Office
5635 Fishers Lane
Suite 550
Rockville, MD 20852
USA
Check or money Postal mail only to:
order Regulatory Affairs Professionals Society RAC
5635 Fishers Lane, Suite 400
Rockville, MD 20852
USA
International wire Fax a completed application form and copy of bank wire confirmation to confirm your application to:
transfer RAPS Account
#1000043228997; ABA #061000104 Swift Code SNTRUS3A; Suntrust Bank, 303 Peachtree St. NE,
Atlanta, GA 30308.
Must reference name of candidate. All bank charges are the responsibility of the payer. For all wire
payments: fax (+1 301 770 2924) or email (certification@raps.org) a completed form and copy of
bank wire confirmation to confirm your registration.

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Application Receipt Confirmation

You will receive an email notification thanking you for your order, which signifies that your appli-
cation has been received. If there are any questions about your application or your application is
selected for audit, you will be contacted by the RAC program office.

Application Audit
RAPS may audit a percentage of applications for completeness and accuracy. If your application is
selected for audit, you will receive email notification of the audit, what types of documentation must
be submitted and the deadline for submission of requested documentation. If you do not comply
with the terms of the audit by the stated deadline, you will not be allowed to take the test and your
examination fee will be refunded minus a $100 processing fee.

Incomplete Applications
If your application is incomplete, you will be notified by the RAC program office, and the application
deficiencies must be corrected by the application deadline. Failure to submit required information
prior to the deadline will lead to rejection of your application and you will be issued a refund of the
examination fee, minus a $100 processing fee.

Application Rejection
Applications for RAC examinations will be rejected for failure to meet eligibility requirements or
falsification of application information. Rejected applicants will be refunded the examination fee,
minus a $100 processing fee.

Application Withdrawal/Cancellation and Refunds

An application may only be withdrawn or cancelled before the application deadline. Requests to
withdraw or cancel an application will not be accepted after this deadline. To withdraw or cancel
an RAC application, you must submit a written request to the RAC program office at certification@
raps.org. There is a $100 processing fee for withdrawn or cancelled applications.

Transferring to Another Testing Cycle

A request to transfer to the next testing cycle may be made without charge before the application
deadline. Requests to transfer to the next testing cycle after the application deadline but before the
end of the testing window will incur a transfer fee of $250. Transfers will be allowed up to 10 days
after the end of the testing window. After this period transfers will not be allowed and applicants
will be required to pay a new application fee at full price. For individuals who require a transfer due
to an unavoidable emergency please see the ‘Emergency Situations’ section.

Appeals Process
Candidates have the right to appeal any adverse decision made by the RAC program office. An
appeal must be submitted in writing not more than 30 days following the date of notification of the
adverse decision. Appeals should be sent to the RAC program office at certification@raps.org or via
US mail to RAPS headquarters. All appeals will be addressed by the RACB. Decisions about appeals
made by the RACB will be final.

Nondiscrimination Policy
The RAC program does not discriminate among candidates on the basis of age, gender, race, religion,
national origin, disability, sexual orientation or marital status.

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EXAMINATION SCHEDULING
Scheduling Your Examination
You will schedule your examination online directly with RAPS’ contracted testing vendor, Scantron.
You will receive a “Notice to Schedule” email from Scantron approximately 15 days prior to the start
of the testing cycle with instructions about how to schedule your examination. Please be sure that
your email address can accept emails from testing@castleworldwide.com. This email will contain a
website link, unique login ID and password. You will use this site to schedule a testing center loca-
tion, test date and time.

Testing
To schedule your examination at a testing center, log into the Scantron scheduling site, you will be
shown the available dates and times at your selected testing center and you will select your pre-
ferred testing date and time. Once you submit your selection you will receive a confirmation e-mail.

You should schedule your examination as soon as possible for the best chance of receiving your
preferred testing date and location. You must submit your test scheduling request at least four days
prior to your preferred testing date. All examinations must be scheduled four days prior to the close
of the testing cycle. Once you have scheduled your examination, you will receive a confirmation
email from Scantron. You must bring a copy of the confirmation email with you to the testing center
on test day.

Scantron reserves the right to cancel any testing site. In the event of a cancelled site, you will be
notified by Scantron and instructed about how to reschedule your testing location and appointment
without additional fees.

International Testing
Applicants looking to schedule an examination outside of the US or Canada should follow the the
instructions to schedule through the Scantron scheduling site. However, should international
sites/dates be unavailable at your preferred international location, you may click on the “More
International Sites” button to see a full list of sites in our network. Consider locations that you may
be traveling to for business or pleasure if you cannot find a location near your home or office. You
may then submit three (3) preferred international site/date options. Scantron cannot guarantee
availability of any international site/date during the designated testing period. Within five (5) busi-
ness days, Scantron will issue a confirmation notice for one of the preferred sites/dates. If none of
the preferred site/dates are available, Scantron will offer an alternate site/date for your approval.
Upon approval, Scantron will issue a confirmation notice.

Changing Your Examination Appointment After it Has Been Scheduled

If you wish to change the date, time or location of an examination that has already been sched-
uled, and that you wish to take in the same examination window, you will need to go to the link on
your appointment confirmation email. If you have difficulty rescheduling online, you can contact
Scantron by telephone at +1 919 572 6880. A fee of $50 (US) for each change is required, payable
to Scantron. Changes may not be made less than five business days before your scheduled examina-
tion date. You may only reschedule to another date within the current testing cycle. If you wish to
reschedule to another testing window, please see ‘Transferring to Another Testing Cycle.’

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Emergency Situations
Under certain circumstances, as outlined below, the RAC program may, at its discretion, transfer an
applicant’s test to the next testing window and waive the transfer fee.

If an applicant cannot take the RAC exam for one of the following reasons:
• A documented, personal medical emergency
• A death in your immediate family
• Unexpected military deployment

The applicant may request to transfer to the next testing cycle. In such circumstances the applicant
must contact the RAC program office no more than five days after the scheduled examination date
(if a date has already been scheduled through the testing vendor).

A personal medical emergency means that the candidate has experienced a medical issue. Transfer
requests are not applicable for medical issues affecting family members. To apply for a transfer
waiver the appropriate documentation must be submitted to the RAC program office no later than
30 days of your scheduled examination date. Candidates will not be eligible for a refund following a
transfer. Work-related emergencies do not qualify for this exception.

Failure to Schedule an Examination or Appear for Your Examination

Appointment
If you do not schedule an examination appointment or you fail to appear for your scheduled exam-
ination appointment, you will be considered a ‘no-show’ and will forfeit all examination fees. The
following are situations in which you will be considered a ‘no-show’:
• Failure to schedule an examination appointment during the testing cycle
• Failure to appear at your scheduled appointment
• Arriving at the testing site more than 15 minutes after your scheduled appointment time
• Failure to have appropriate photo identification at the examination appointment

If you fail to schedule or appear, you may reapply to take an RAC examination in the future and will
be required to pay full application fees.

Special Accommodations for the Examination

Candidates who require special accommodations under the Americans with Disabilities Act (ADA)
and ADA Amendments Act (ADAAA) should send the completed Special Accommodations Request
Form with the Documentation of Disability-Related Needs form (see Appendices B and C) completed
by a qualified professional, to the RAC program office at certification@raps.org or RAPS headquar-
ters at the time of application. The request must indicate the nature of the disability and specific
testing accommodations requested. Candidates will be notified in writing if their request is approved.

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ON EXAMINATION DAY
What to Bring to the Testing Center
You should arrive at the testing center at least 15 minutes before your scheduled appointment for
check in. You must bring a copy of the examination appointment confirmation email with you.

To be admitted to the testing center you must bring current, valid government-issued identification
(ID). Your identification must include your name (in English characters or translation to compare
with your RAC application information), photograph and signature.

You are required to present a valid, government-issued photo ID (e.g., driver’s license, passport,
state-issued ID card) on exam day; please ensure that your first and last name on the valid, govern-
ment-issued photo ID EXACTLY match your first and last name as they appear on the scheduling
screens. If your first and last names are incorrect, please contact RAPS immediately at (301) 770-
2920, ext. 200. If you have more than one last name listed on your government-issued ID, the same
last names must be reflected on your confirmation email. If you do not provide appropriate and/or
matching identification, you will not be permitted to take the examination and will forfeit all exam-
ination fees.

The following are acceptable forms of government-issued identification:

• driver’s license
• military ID
• passport
• national identification card

Items Prohibited at the Testing Center

Candidates are expressly prohibited from bringing the following items to the test center:
• cameras, cell phones, optical readers or other electronic devices that include the ability to
photograph, photocopy or otherwise copy test materials
• notes, books, dictionaries or language dictionaries
• book bags,luggage, purses or handbags
• iPods, mp3 players, tablets, headphones or pagers
• calculators, computers, PDAs or other electronic devices with one or more memories
• personal writing utensils (i.e., pencils, pens and highlighters)
• watches and other jewelry except wedding or engagement rings
• food and beverages
• coats and jackets
• weapons
• Hats, hoods or other headwear are not permitted in the examination room unless required
for religious purposes. All items are subject to inspection by the proctor if suspicious behav-
ior is detected.
• Please note that sweaters and sweatshirts without pockets or hoods are permitted.

You will be provided with:

1. paper and pencil or erasable noteboards and markers at the test center
2. have an abbreviations table

Please note that Scantron testing centers administer examinations for multiple organizations.
Individuals in the testing room with you may be taking different examinations and have different
rules for their examination including time and what is allowed at their testing station.

Other Considerations
• Smoking is prohibited.
• You may not ask questions about examination content.
• All examinations are monitored and may be recorded in both audio and video format.

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• No breaks are scheduled during the examination. If you need to leave the testing room to
take a break, you will not be given extra time to finish the examination. You may be required
to present your ID when returning to the testing room.

Cancellation Due to Inclement Weather

In the event of bad weather, a natural disaster or other emergency, Scantron will post the informa-
tion on their website. Candidates scheduled at a site operating on a delay will receive an email from
Scantron. Should the site be closed entirely, Scantron will contact the candidates to reschedule.

Examination Security and Confidentiality

The RAC examinations are the sole and exclusive property of the RAC program. These materials are
confidential and not available for review by any person or organization other than the RACB and
the examination committees. Copying, publishing or disclosing examination content in any form is
considered a violation of the RAC Security and Confidentiality policy and will be subjected to disci-
plinary action which may include termination of a testing session, invalidation of test results and/or
revocation of an RAC credential.

Termination of Examination Administration/Dismissal From the Testing Center

You are expected to conduct yourself in a professional manner at all times at the testing center.
The test center administrator or proctor is authorized to dismiss you from an examination and/or
request that a test score be cancelled if you engage in any of the following:
• using or attempting to use someone else to take the examination
• using notes or other study materials during the testing process
• creating a disturbance. Disruptive behavior in any form is not tolerated. The test adminis-
trator has sole discretion to determine what constitutes disruptive behavior.
• communicating in any manner with anyone other than the administrator or proctor during
the testing process
• leaving the testing room without permission
• tampering with a computer
• removing or attempting to remove any material from the testing room
• failing to follow any examination policies or requirement explained in this Candidate Guide

Problems at the Testing Center

The RAC program and Scantron take steps to assure that the RAC examination process is effec-
tive. However, irregularities may sometimes occur. If you encounter technical difficulties during
the examination, please contact the proctor immediately. If a delay exceeds 30 minutes, you may
request to reschedule your examination to another date if you are unable to wait any longer.

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AFTER THE EXAMINATION

Examination Scoring
RAC examinations are scored by Scantron after the close of the testing cycle. Examinations are not
scored at testing centers. A statistical report of scoring is reviewed by a statistician and the exam-
ination committee to assure ongoing quality of the examinations.

All scores are reported on a scale of 0 to 99 with 75 being the passing score. The scaled score
is neither the number of questions answered correctly nor the percent of questions answered
incorrectly. You cannot look at the scaled score and determine the number of correctly answered
questions needed to pass the examination.

Notification of Examination Results

Examination results are typically available four to six weeks after the close of the testing cycle.
You will receive an email notification with your results. Results are released only to candidates. No
results will be reported over the telephone or by fax.

RAC Recognition
A list of all active RAC-credentialed professionals is available online at RAPS.org/RAC. Newly cre-
dentialed professionals are added after all candidates are notified of their status. If you do not wish
to be included in the online listing, please contact the RAC program office.

Use of the RAC Designation

When you pass an RAC examination you may use the RAC designation after your name as a profes-
sional credential. You should list your RAC and specific RAC credentials on your resume, curriculum
vitae, employment or other professional records. The RAC designation cannot be used by individu-
als who fail to maintain the RAC credential by meeting recertification requirements.

Retaking the Examination

Candidates who do not pass the RAC examination are eligible to retake the examination. To apply
for re-examination, candidates must submit a new application. There is no limit on the number of
times a candidate can take an examination. Candidates can retake the exam as soon as the next
testing window.

Release of Information
The RAC program maintains strict procedures for ensuring the confidentiality of all candidate
records. Information about candidates is released only to the candidates themselves. Scores are
only released to the candidate and are not released by telephone or fax even to the candidate.

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RECERTIFY
Maintaining Your RAC Credential
Continual learning, knowledge enhancement and professional development are vital to regulatory
professionals. Once certified, you maintain your RAC through continued learning and involvement
in professional activities. You are required to renew your RAC every three years by earning 36 RAC
recertification credits. Credits may be accumulated in many ways, including participation in con-
tinuing education, public speaking on regulatory topics, professional writing and involvement with
professional organizations.

Individuals who hold more than one RAC designation are only required to submit a single recerti-
fication application with a total of 36 credits. The recertification cycle is based on the initial RAC
certification and the related recertification cycle. You can find detailed information about maintain-
ing and renewing your RAC in the RAC Recertification Guide.

Contact Information
Regulatory Affairs Professionals Society
Attention: RAC Program Office
5635 Fishers Lane, Suite 400
Rockville, MD 20852
USA
Tel +1 301 770 2920, ext. 200
Fax +1 301 770 2924
Email: certification@raps.org

Scantron
6001 Hospitality Court, #100
Morrisville, NC 27560
+1 919 572 6880
email: testing@castleworldwide

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APPENDIX A: RAC (DEVICES) DETAILED

EXAMINATION CONTENT OUTLINE
Each examination is based on a survey of the scope of practice and specific roles and responsibilities
of regulatory professionals in the workplace with at least three years of regulatory experience. Each
examination is reviewed and revised annually and content is updated for the October/November
exam cycle. Examination content for the RAC (Devices) exam is based on regulations and guidelines in:

Domain I: Strategic Planning – Exam Weighting approximately 29%

• Task 1: Determine the proposed product classification by using the relevant regulation to
prepare for regulatory pathway and submission strategy.
• Task 2: Evaluate the regulatory environment and provide internal advice throughout the
life cycle of the product (e.g., concept, development, manufacturing, marketing) to facilitate
product compliance.
• Task 3: Provide input regarding comparative effectiveness/health technology assessment
associated with reimbursement.
• Task 4: Perform risk/benefit analysis on product development concept for initial product
viability.
• Task 5: Provide direction for safety and effectiveness testing (e.g., bench, preclinical, clini-
cal) at the feasibility phase to determine the ability to comply with regulatory requirements.
• Task 6: Collaborate with and advise research and development programs regarding applica-
ble regulatory compliance.
• Task 7: Provide regulatory intelligence to develop local, regional, and global regulatory
strategies.
• Task 8: Evaluate the regulatory outcomes from the initial product concepts and make rec-
ommendations for future actions.
• Task 9: Research and interpret regulatory decisions in a similar product category to assess
regulatory approval implications.
• Task 10: Identify appropriate regulatory authorities for submission of data for product
being developed.
• Task 11: Assess impact of local, regional, and global requirements and considerations on the
content of regulatory submission/dossiers.
• Task 12: Evaluate global filing strategy (e.g., simultaneous filings, joint reviews, mutual
recognition agreements, assessment of similarity or dissimilarity of requirements) to define
market feasibility.
• Task 13: Anticipate regulatory concerns arising from trade issues (e.g., applicable treaty law,
international conventions, “for export only” status).
• Task 14: Provide alternative strategies for product development and submission to ensure
timely approval and advise internal stakeholders on the requirements.
• Task 15: Develop and review regulatory department standard operating procedures to
achieve regulatory compliance.
• Task 16: Participate in internal training programs for company personnel to achieve regula-
tory and quality compliance.
• Task 17: Assist other departments to develop standard operating procedures to achieve
regulatory compliance.

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Domain II: Pre-marketing – Exam Weighting approximately 25%

• Task 1: Evaluate need for and contribute to product development for special patient
populations (e.g., pediatric investigation plan/waivers/deferral, orphan devices, and human-
itarian device exemptions).
• Task 2: Advise stakeholders of regulatory requirements for quality, bench, preclinical, and
clinical data.
• Task 3: Assess the acceptability of quality, bench, preclinical, and clinical documentation for
submission filing to meet regulatory requirements.
• Task 4: Negotiate and interact through appropriate communication tools (e.g., meetings,
email) with regulatory authorities before and during the product development and review
process to facilitate submission approval.
• Task 5: Determine acceptability of submission package through the preparation and review
of relevant sections to comply with applicable requirements.
• Task 6: Compile and prepare regulatory submissions according to relevant guidelines and
submit to the appropriate regulatory authorities.
• Task 7: Monitor the progress of the regulatory authority review process through appropri-
ate communication with the agency.
• Task 8: Evaluate the impact on the regulatory submission strategies of proposed manufac-
turing changes during the preclinical development and clinical studies.
• Task 9: Facilitate the development of appropriate and timely responses to regulatory
authority queries and actions to meet regulatory requirements.
• Task 10: Participate in developing a risk management system to ensure that local, regional,
and global regulatory requirements are met.
• Task 11: Identify and monitor events and processes and, as applicable, submit reports (e.g.,
serious adverse events, periodic reports, final study reports) or notifications (e.g., changes
in manufacturing) to regulatory authorities to comply with regulations.
• Task 12: Interact with other companies associated with acquisitions and collaborations.
• Task 13: Interact with and record the use of contract research organizations, subcontrac-
tors, test facilities, and consultants.
• Task 14: Review documentation of raw materials to ensure compliance with regulatory
requirements.

Domain III: Post-marketing – Exam Weighting approximately 38%

• Task 1: Review advertising and promotional materials for regulatory compliance.
• Task 2: Review and provide input to labeling to comply with regulatory requirements.
• Task 3: Submit notifiable changes and supplemental dossier to the appropriate regulatory
authorities to update product information and/or instructions for use to reflect current
state of product.
• Task 4: Verify that appropriate standard operating procedures are in place to manage prod-
uct associated events, complaints, recalls, market withdrawals, and safety reports.
• Task 5: Provide input to the risk assessment associated with product issues and implement
appropriate regulatory steps to address issues (e.g., consumer information, advertising,
labeling changes, warnings, alerts, product changes, recalls, withdrawals).
• Task 6: Participate in implementing regulatory strategy for handling recalls and commu-
nication to stakeholders (e.g., dear healthcare provider letters, patient letters, distributor
letters, health authorities).
• Task 7: Report notifiable manufacturing product-associated events (e.g., failures, recalls,
corrective actions resulting from inspections) to regulatory authorities as required.
• Task 8: Report product safety issues to regulatory authorities as required to comply with
local, regional, and global regulations.

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• Task 9: Submit single case or aggregate safety reports to comply with local, regional, and
global regulations or upon request by regulatory authorities.
• Task 10: Comply with product post-marketing surveillance requirements to meet condi-
tions of approval.
• Task 11: Proceduralize the regulatory assessment process to define notifiable changes to
comply with local, regional, and global regulatory authorities for post-marketing changes.
• Task 12: Evaluate change control documents to determine the level of change and conse-
quential submission requirement.
• Task 13: Participate in crisis/issue management team (e.g., product recall, counterfeiting)
and assess the regulatory impact of an event and proposed resolution.
• Task 14: Review regulatory aspects of contracts (e.g., quality, product complaints, recalls,
vigilance) for product manufacture and distribution.
• Task 15: Control access to regulatory documentation, ensuring confidentiality and protec-
tion of proprietary information.
• Task 16: Maintain licenses (e.g., establishment, narcotics, controlled substances) and submit
renewals as required.
• Task 17: File new and amended patent/trademark forms to update information with appli-
cable regulatory authorities to meet regulations.
• Task 18: Provide required information (e.g., clinical data) in support of product reimburse-
ment requests.
• Task 19: Submit documentation and samples for lot release, if required, for customs
clearance.
• Task 20: Demonstrate that quality systems are in place (e.g., ISO 13485 for medical
devices).
• Task 21: Comply with import and export requirements.
• Task 22: Demonstrate compliance with applicable market controls and requirements (e.g.,
controlled substances, veterinary use only).
• Task 23: Assess adequacy of product traceability systems.

Domain IV: Interfacing – Exam Weighting approximately 8%

• Task 1: Communicate and negotiate with regulatory authorities and stakeholders to facili-
tate compliance on regulated products.
• Task 2: Review public communications, press releases, etc., to ensure regulatory
compliance.
• Task 3: Participate in internal product review committees (e.g., labeling, quality, launch).
• Task 4: Develop early warning systems to identify potential regulatory compliance issues
affecting the company and advise affected internal functional groups.
• Task 5: Identify and interact with the standards-developing organizations that are appropri-
ate for the company’s product.

All Tasks may be examined under the following knowledge or skill areas:
a. Regulatory intelligence
b. Product development
c. Risk management
d. Licensing, registration, and maintenance
e. Post-market activities

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APPENDIX B: SPECIAL
ACCOMMODATIONS REQUEST
The Regulatory Affairs Certification Board (RACB) may provide accommodations to candidates
with a disability as defined by the Americans with Disabilities Act (ADA). Please review the RAC
Candidate Guide before submitting this form to be sure you quality for special accommodations.

Please type or print

Name_____________________________________________________________________________________________________
First Last MI

Address__________________________________________________________________________________________________
Street Mail Stop/Suite/Apt

___________________________________________________________________________________________________________
City State/Province Zip

Country__________________________________________________________________________________________________

Phone (with area/country code)_________________________________________________________________________

Email address____________________________________________________________________________________________

For which of the following examinations are you requesting accommodations?

RAC (US)
RAC (EU)
RAC (CAN)
RAC (Global)
RAC (Devices)
RAC (Drugs)

Type of accommodation you are requesting____________________________________________________________

___________________________________________________________________________________________________________

Have you previously received accommodations in any educational or testing situation?

Yes
No

If yes, please describe the accommodations received__________________________________________________

___________________________________________________________________________________________________________

I certify that the above information is true and accurate.

Signature ______________________________________________ Date___________________________________

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APPENDIX C: DOCUMENTATION OF
DISABILITY-RELATED NEEDS
To the Professional: The individual identified below is requesting accommodations for the
Regulatory Affairs Certification (RAC) examination. The Regulatory Affairs Professionals Society
requires that candidates requesting testing accommodations provide documentation of the disabil-
ity from a person qualified to assess the disability.

By completing and signing this form, you are verifying that the individual named below has been
diagnosed with the stated disability and the recommended accommodation is required to fairly
demonstrate the candidate’s ability on the examination.

Candidate Name_________________________________________________________________________________________
First Last MI

Please include the following:

1. Diagnosis (note: mental and emotional disabilities must include a diagnosis from the DSM-IV)

___________________________________________________________________________________________________________

___________________________________________________________________________________________________________

___________________________________________________________________________________________________________

2. Description of the candidate’s disability and how the disability affects the candidate’s major life
activities (e.g., hearing, seeing, walking, talking, performing manual tasks)

___________________________________________________________________________________________________________

___________________________________________________________________________________________________________

___________________________________________________________________________________________________________

3. Recommended Accommodations:

___________________________________________________________________________________________________________

___________________________________________________________________________________________________________

___________________________________________________________________________________________________________

Name___________________________________________________________________________________________

Contact Email/Phone____________________________________________________________________________________

Signature ______________________________________________ Date___________________________________

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APPENDIX D: CODE OF ETHICS

As the international leader for the healthcare regulatory profession, RAPS has initiated and
supported the development of this code of ethics for the profession. Following a series of surveys
and focus groups held over two years, a task force of volunteers was convened in February 2003.
Their work, reviewed and shaped by many regulatory professionals, forms this code.

The task force identified eight core values that regulatory professionals embrace. The principles
embodied by these core values are outlined in the section (below) entitled “Fundamental Principles.”
Following that, each core value is presented with suggested behaviors that should be encouraged or
discouraged.

RAPS believes that this is a living document and encourages your feedback. Use this code of conduct
in your work and share it with your colleagues and employer.

Statement of Personal Responsibility

Regulatory professionals have the professional and ethical responsibility to maintain the highest
standards of professional conduct as they exercise their professional duties of upholding and
clarifying the laws and regulations of the authorities under which we operate.

As individual regulatory professionals, we are making a positive contribution to public health and
we aspire to embody this code of ethics in our words, actions and deeds.

As regulatory professionals, we play a pivotal role in ensuring compliance with applicable laws and
regulations in the development and commercialization of healthcare products. We are a diverse
profession: we work in healthcare companies, for government regulatory agencies, for contract
research organizations and as independent consultants around the world. Our profession includes
attorneys, engineers, managers, nurses, pharmacists, physicians and scientists, among others.
We are a growing profession and we are developing and continually exploring our core values in
an increasing complex global regulatory environment. We do this in the hope that everyone who
practices in this field will aspire to these principles. We do this also in the hope that those whom we
serve will hold these principles as inviolable.

The following eight core values defined below are maintained from the original code:

• Regulatory Compliance
• Competency
• Objectivity
• Integrity
• Honesty/Credibility
• Accountability
• Equitability
• Dignity and Respect

Fundamental Principles
As a regulatory professional I aspire to:

• To ensure my employer’s activities are conducted in compliance with the laws and
regulations of the authorities under which we operate, consistent with advancing,
preserving and protecting public health.
• Be competent to perform the services I have been hired or retained to perform. As a
regulatory professional, I hereby commit myself to continual learning while being able to
acknowledge areas outside my expertise.

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• Act in an objective manner. As a regulatory professional, I will base decisions on factual

information. I will not be unduly influenced by competing or conflicting interests and I will
clearly communicate competing or conflicting interests when appropriate.
• Have integrity. As a regulatory professional, I must be principled and consistent in applying
my views. I must live up to my commitments, and be trustworthy and scrupulous at all times.
• Be honest in all dealings with my employers and others with whom I interact. As a
regulatory professional, I must ensure all information and communications, whether oral
or written, are accurate and complete. I acknowledge and affirm personal and institutional
credibility is crucial to my success.
• Have the courage to make difficult decisions. As a regulatory professional, I will present
all relevant information to my organization to promote wise decisions. I must be able
to withstand challenges to my views, while at the same time being accountable for my
mistakes.
• Be fair in my dealings with all parties. As a regulatory professional, I must apply legal and
regulatory standards equitably. I must be just in considering the interests of all parties in
decision processes.
• Be respectful of others. I must treat all individuals with dignity and courtesy.

Duty
Our role as regulatory professionals is defined by our duty to advise individuals and organizations
regarding the appropriate regulatory context for actions they may want to take.

Our role is further defined by our obligations as employees of companies making important medical
products for patients, as members of teams conducting nonclinical and clinical studies, as regulators
and as members of our profession.

Regulatory professionals have a duty to:

Disseminate and interpret relevant governmental regulations, industry standards and good practice
guidelines without bias.
Ensure products are safe and beneficial to patients, while maintaining the long-term interests of our
employers.
Ensure, to the extent possible, the benefits justify the risks for those who participate in clinical
studies and who use regulated products.
Provide physicians and other healthcare professionals with accurate and complete information
about the safety and effectiveness of products.
Maintain the long-term integrity of our profession and strive to deserve the public’s confidence and
respect.

Competence
Competence means a regulatory professional has the knowledge, experience, ability and skill
necessary to effectively identify, analyze and solve or recommend solutions to regulatory
challenges. Regulatory professionals must be dedicated and flexible enough to adapt to the ever-
changing realm of the regulatory profession.

The diversity of individuals and organizational contexts within the regulatory profession
necessitates commitment to continually develop competence by a variety of means: seeking
continuing education, work experience, professional training and certification.

Just as the regulatory profession continues to evolve, maintaining competence within the field is a
continual learning process.

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Regulatory professionals develop competence by:

• Being informed and knowledgeable about cur-rent and future trends.

• Claiming competence only in areas where they have a thorough understanding.
• Encouraging and supporting professional growth and development among peers and
subordinates so all who work in the field can gain and demonstrate competence in the
profession.

Objectivity
Regulatory professionals must be objective and must display their objectivity by representing facts
without distortion by personal feelings or biases. The regulatory professional must understand the
facts and must evaluate information from several points of view.

Regulatory professionals must understand their decisions may affect the interests of many parties
including companies, regulators, healthcare professionals, patients and shareholders. Regulatory
professionals must be aware of these differing interests without letting them influence their final
regulatory interpretations and actions.

Regulatory professionals develop objectivity by:

• Responding carefully to opinions and issues and recognizing a single right or wrong answer
is rare. Opinions can often take on a partisan perspective. The regulatory professional
should always strive to offer an unbiased expression of facts.
• Presenting reasonable regulatory opinions, options and associated risks when developing
regulatory strategies.
• Clearly differentiating among regulatory requirements, internal requirements and personal
preferences.
• Disclosing new information appropriately within the proper context.

Integrity
Regulatory professionals with integrity will not compromise their values or trustworthiness for
personal gain or professional enhancement. Individuals with integrity are principled, scrupulous and
trustworthy. Having integrity suggests that one is “whole,” and one’s beliefs, words and actions are
congruent and consistent.

Regulatory professionals develop and maintain integrity by:

• Keeping commitments.
• Giving credit for the work of others.
• Maintaining confidentiality of information and never disclosing information concerning the
business or technical affairs of others without their consent.
• Seeking advice from others when uncertain.
• Considering their obligations and the long-term consequences of their actions when asked
to compromise integrity for the sake of one party over another.
• Avoiding situations that put their integrity at risk.
• Recognizing the best course of action may not be in the short-term interest of their
employer.
• Accepting compensation only when earned.
• Avoiding conflicts of interest or making conflicts known when they are unavoidable.

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Honesty
Regulatory professionals must exhibit honesty in all of their activities. Honesty is truthfulness,
candor and sincerity. Honesty requires a regulatory professional to act in ways free from deceit or
deception, including dishonesty by omission or failing to say something when comment is ethically
required. Honesty requires candid and forthcoming actions, not simply refraining from false
statements.

Regulatory professionals build honesty and trust, which is absolutely essential to fostering effective
working relationships, by:

• Ensuring information is accurate and complete.

• Protecting against the omission of information or the creation of false impressions.
• Resisting pressures to relax standards of honesty, for example, to achieve expediency.
• Representing a complete profile of the product under review in all regulatory submissions.

Courage
Regulatory professionals demonstrate courage by choosing the right thing even when doing so
is difficult. Regulatory professionals must have the courage to evaluate, conclude and provide
consistent and accurate regulatory advice while accepting the consequences of their actions. They
must gain access to information required to do their jobs as completely as possible.

Regulatory professionals develop courage by:

• Reviewing and reiterating their advice and strategy when necessary or when challenged
and changing their advice when appropriate.
• Asking for help when needed.
• Encouraging an open exchange of views even if those views challenge their regulatory
advice.
• Admitting mistakes, accepting accountability and taking appropriate measures to promptly
correct any errors, miscommunications or misperceptions.
• Delivering bad news quickly to management when necessary.
• Providing information to stakeholders about regulatory risks and describing consequences
if regulatory advice is overruled or ignored.

Fairness
Regulatory professionals strive to treat all persons fairly, equitably and equally in accordance
with the law by holding all those with common responsibilities to a common standard. Regulatory
professionals should consider the rights and needs of all parties in the context of all applicable laws,
regulations and scientific and societal norms.

Regulatory professionals demonstrate fairness by:

• Respecting the letter and spirit of laws and regulations.

• Applying the appropriate legal and regulatory standards to all cases.
• Taking into account cultural and regional differences and local requirements.
• Presenting the facts and objective analysis of scientific information using sound statistical
interpretation to minimize bias while clarifying uncertainty.
• Ensuring all interests, public and private, are appropriately considered in the regulatory
decision processes.

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Respect
Regulatory professionals demonstrate respect by appreciating the worth or value of people and
things. Regulatory professionals must respect the roles of their colleagues and should recognize and
acknowledge the worth of all parties.

Regulatory professionals develop respect by:

• Listening to what others have to say.

• Treating all parties, regardless of level or position, with dignity, civility and courtesy.
• Accepting personal differences but working diligently toward accommodating those
differences where ever possible.
• Creating a positive environment encouraging participation of all parties without
embarrassment, ridicule or hurtful actions or inactions.
• Sharing what they know in a nonintimidating way.
• Tolerating and encouraging those who do not initially understand.
• Avoiding conflict where possible and finding creative ways to resolve conflict quickly.
• Being patient and forgiving when others make mistakes and working to prevent mistakes
from recurring rather than assigning blame

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USA

RAPS.org/RAC

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