HHS Publication FDA 87-4002

IMPACT RESISTANT LENSES

QUESTIONS AND ANSWERS

Project Officers
Walter M. Snesko and John F. Stigi
Office of Training and Assistance

Revised September 1987

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
Center for Devices and Radiological Health
Rockville, Maryland 20857

Snesko, W. M. and J. F. Stigi. Impact Resistant Lenses: Questions and Answers. HHS Publication
(FDA) 87-4002 (September 1987) (27 pp.)
Eyeglasses and sunglasses are medical devices. As such, they are subject to medical device
regulations under the Food, Drug, and Cosmetic Act. To reduce the number of eye injuries,
eyeglasses and sunglasses must be fitted with impact resistant lenses. Glass lenses, plastic
lenses, or laminated glass lenses can be made impact resistant by any method. However, all
lenses must be capable of withstanding the impact test described under 21 CFR Part
801.410(d)(2). This booklet answers questions on such topics as the lens testing apparatus,
records maintenance, and exemptions to testing.

CONTENTS
Page
2

Abstract
Introduction

Testing Apparatus and Procedures

Who Must Test and When

Exemptions
Sampling Plans
Records
Dispensing Untested Lenses
Frames and Designs
Other Lens Types
Premarket Notification
Liability
References
Appendixes
A. FDA District Offices
B. Voluntary Standards

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INTRODUCTION
The Food and Drug Administration (FDA), the leading consumer protection agency in the United
States, began to regulate eyeglasses in the early 1970's.
In 1984, 120 million persons in the U.S. wore eyeglasses and 19 million lenses were imported,
constituting a $7.5 billion industry in the United States.
Eyeglasses and sunglasses are medical devices. As such, they are subject to medical device
regulations under the Food, Drug, and Cosmetic Act. Other forms of eyewear such as safety
glasses and sports glasses -- including swimmers' racing goggles, ski goggles, and racquetball
glasses -- are not regulated as medical devices unless they have prescription lenses, and thus are
not subject to the medical device regulations.
To reduce the number of eye injuries, eyeglasses and sunglasses must be fitted with
impact-resistant lenses. Consumers should understand that the regulation requires a minimum
level of impact resistance but does not require that the lens act as an unbreakable shield. Glass
lenses, plastic lenses, or laminated glass lenses can be made impact resistant by any method.
However, all lenses must be capable of withstanding the impact test described under 21 CFR Part
801.410(d)(2) (see Appendix D for the complete ruling, hereafter referred to as "the regulation").
The number of lenses actually tested for impact resistance within each batch or lot varies
depending on material and type of lens [21 CFR Part 801.410(c)(3)]: all glass lenses for prescription use must be tested, but statistical sampling is allowable for over-the-counter glass lenses,
glass laminate and plastic lenses, and also for prescription glass laminate and plastic lenses.
Certain lenses which are prescribed infrequently for specific, uncommon visual needs have physical designs that render them unsuitable for impact testing. These lenses [see 21 CFR 801.410(e)
(3) for specific types] must be rendered impact resistant but need not be tested. Statistically
accurate samples of plastic lenses (prescription or over the counter (OTC)) and glass OTC lenses
must be tested for impact resistance. Because not all lenses are tested, it is possible that some
lenses are not impact resistant, although most will be.
Consumers, manufacturers, and sellers should remember that the strength of any lens is related to
the condition of its surface. All lenses lose their impact strength in direct proportion to the
breakdown of the polished surfaces. The greater the number and depth of any scratches, the
weaker the lens becomes. For consumers, there is an inherent hazard in continuing to wear
scratched lenses because their impact strength is reduced. Spectacle wearers also should be aware
that streetwear or dress plastic lenses are not necessarily impact resistant simply because they are
manufactured of a plastic material. Although plastic lenses must pass the impact test, they are not
necessarily the same as "safety glasses" for industrial use.
Since the first edition of this booklet was published in June 1972, considerable changes have
occurred in Federal regulation of impact-resistant lenses. This third edition explains the changes
and continues to answer questions that industry and consumers most frequently ask FDA about
impact-resistant lenses.
Factors having significant influence on current requirements of the regulation are as follows:

the Medical Device Amendments of May 28, 1976, which established responsibility for
enforcement and administration by the Center for Devices and Radiological Health (CDRH)
within FDA.

experience by FDA in applying the regulation to eyeglass and sunglass lenses.

4

technological advancements in eyeglass lenses. changes in the marketplace for eyeglasses.

the amendment of April 6, 1979, (44 FR 20676) to the regulation, which (1) allowed lenses to
be tested for impact resistance by any test equivalent or superior to the drop-ball (referee)
test, and (2) described specific prescription lenses that must be impact resistant, but need not
be tested for impact resistance.

For more information on this topic, contact your local FDA district office (see Appendix A) or
CDRH at either of the following addresses:
Food and Drug Administration
Division of Compliance Operations
8757 Georgia Avenue
Silver Spring, MD 20910
Division of Small Manufacturers Assistance
5600 Fishers Lane (HFZ-220)
Rockville, MD 20857
Phone (800) 638-2041

TESTING APPARATUS AND PROCEDURES

1. Q.
A.

What is the "Referee" or "Drop Ball" test and how is it done?

The test used to determine impact resistance, and which is described in the regulation, is
commonly called the "drop ball test." The term "referee test" refers to the use of this test
in determining compliance with a regulation.
The exact procedure for the impact test is given in 29 CFR 801.410(d)(2) (see Appendix
C). In brief, though, a 5/8-inch steel ball weighing approximately 0.56 ounce is dropped
from a height of 50 inches upon the horizontal upper surface of the lens. The ball must
strike within a 5/8-inch diameter circle located at the geometric center of the lens. The
ball may be guided but not restricted in its fall by being dropped through a tube extending
to within approximately 4 inches of the lens. To pass the test, the lens must not fracture;
for the purpose of this regulation, a lens will be considered to have fractured if it cracks
through its entire thickness and across a complete diameter into two or more separate
pieces, or if any lens material visible to the naked eye becomes detached from the ocular
surface (i.e., the surface of the lens that is closest to the eye when the lens is in actual
use).

2. Q.

What criteria does FDA use to determine whether a fractured lens passes the test?

A. If the crack or fracture in any lens continues from the outside (objective) surface
through to the ocular surface, the crack is considered to be through the lens's entire
thickness and the lens has failed the test. However, if a laminated lens has a crack only
through to the lamina, not disturbing the other side of the lens, then the crack is not
considered to be through the thickness and the lens has passed the test.
A lens is not considered impact resistant if it cracks during the test and each piece is
approximately 50 percent of the lens (i.e., across the diameter). However, if, for
example, only 1/4 of the lens is separated from the remaining lens (not across the
diameter), the lens may be considered impact resistant. Such determinations are
subjective, and acceptability of the lens may depend on whether the sample being tested
has a high failure rate. For example, if the lot being tested was not well within
Acceptable Quality Level (AQL) of 6.5, general inspection level II in MIL STD 105D,
and the decision to pass or fail the lot depended on this lens, the inspector should be
prudent and consider the lens unacceptable. Likewise, a lens is not considered impact
resistant if its ocular surface chips during the test. In use, this small segmented piece
would represent a potential hazard to the eye.
3. Q. Must the apparatus used in the referee test have a tube to guide the steel ball as it falls
toward the lens?
A. No. The regulation provides that a tube may be used, but is not necessary. If used,
however, the tube must not interfere with the free fall of the ball.

4. Q. May a referee apparatus, which has a base and rigidly attached fixtures that weigh less
than 27 pounds, be modified to meet the weight specification?
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A. Yes. A heavier base plate may be used or a modification made, such as attaching the base
plate to a workbench or table in such a way that the bench or table is considered to be an
integral part of the support system or of the apparatus itself. FDA requires that the
apparatus used to test the lenses have a solid support system. FDA will use test fixtures
weighing more than 27 pounds.
5. Q.

Does FDA require a neoprene gasket on testing apparatus requiring support tubes?

A. Yes.
6. Q.

May the manufacturer secure the lens in the testing apparatus to prevent lens movement or
repeated impact with the ball following the first impact with the ball?

A. The regulation contains no provisions for securing the lens. FDA does not intend to secure
the lens during testing. Nevertheless, measures to protect the lens from damage during
testing are permitted, as long as these measures do not interfere with the validity of the
test results. (See Appendix C.)
7. Q.
A.

8. Q.
A.

9. Q.

How may manufacturers test laminated lenses for impact resistance?

Laminated eyeglasses or sunglasses may be drop ball tested individually or on the same
statistical basis as plastic lenses unless they are of a type, as specified under 21 CFR
801.410(c)(3), unsuitable for impact testing.
Must manufacturers test plastic lenses in a variety of thicknesses?
Manufacturers must test plastic lenses on a batch sampling statistical basis. The regulation
states that the lenses tested "shall be representative of the finished forms ... of minimal
lens thickness ...." (see Appendix C). In practice, this means that manufacturers who sell
partially-ground lens blanks to optical laboratories or other reprocessors must (1) tell
these customers the degree of thickness at which the lenses were tested and (2) caution
them to test each lens that is further processed to a thickness less than this minimal level.
May the manufacturer use tests other than the referee test to demonstrate impact
resistance?

A. An alternate method of testing the impact resistance of lenses may be used if the
manufacturer' can prove that the alternate method is equal or superior to the referee test.
The FDA need not preapprove any alternate testing method.

10. Q.
A.

If a lens breaks during an FDA test, is the manufacturer in violation of the regulation?
Not necessarily. Each situation will be reviewed and violations determined by the
conditions surrounding the case and by the testing status of the lens (i.e., whether the
lens was individually tested or was part of a batch sampled on a statistical basis).

WHO MUST TEST & WHEN

11. Q. Who should perform the test for impact resistance?
A.

The manufacturer, as defined in the answer to question 12, is responsible for performing
the test for impact resistance.

12. Q. In terms of the regulation, who is the manufacturer?

A

13. Q.

The manufacturer is the person who puts the lens in the form ready for its intended use
or who alters the physical or chemical characteristics of the lens by such acts as grinding,
heat treating, beveling, or cutting. For the purpose of this regulation the term
"manufacturer" includes a company that imports eyeglasses for resale.
At what stage of fabrication (manufacture) must impact-resistant lenses be tested?

A. The lenses must be tested when fabrication and treatment are complete and the lenses
are ready for insertion into the eyeglass or the sunglass frames.
The exception is that plastic lenses may be tested in the "uncut-finished" stage (i.e., when
both surfaces are formed to prescription curvatures and thickness, but edges of the lenses
are not yet cut to frame size and shape).
14. Q.

Does the regulation apply to lenses manufactured abroad for import into this country?

A.

Yes. The regulation applies to all lenses in interstate commerce, regardless of their origin.

15. Q.

May an optical wholesaler or processing laboratory supply non-impact-resistant lenses to

a retailer who, in turn, wants to render them impact resistant?

A.

Yes.

16. Q.

What is the interpretation of "finished lens" and "finished' form," as used in the
regulation? (See Appendix D.)

A.

A "finished lens" is in "finished form" when all edging operations have been completed
prior to the lens being mounted into a frame and delivered to the patient. At this point, a
monolithic (nonlaminated) glass lens is ready to be treated for impact resistance and
tested.

17. Q.

If retailers put untested plano (noncorrective) lenses in frames such as those used with
customized sunglasses, must they render the plano lenses impact resistant and test them?

A.

Yes. However, mass-produced plano lenses for use in sunglasses need only be tested on a
statistically significant, batch-sampling basis.

18. Q.

May a glass lens, after it has been chemically or thermally treated for impact resistance,
be processed further in any way?

A.

Lenses that are treated for impact resistance by induced surface compression may be
re-edged or modified for power. However, the beneficial effects of surface compression
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may be substantially reduced. Such lenses must be retreated and tested before they are
dispensed to the patient.
19. Q.
A.

Does FDA stipulate one method that must be used in rendering eyeglass lenses impact
resistant?
No. Any proven method may be used, provided that the lenses pass the referee test or an
equivalent test.
EXEMPTIONS

20. Q.
A.

21. Q.
A.

What special prescription eyeglass lenses are exempt from the impact test?
As designated in the regulation, the following special lenses are exempt from statistical
sampling and 100 percent impact testing: prism segment multifocals, slab-off prisms,
lenticular cataracts, iseikonics, depressed segment one-piece multifocals, bioconcaves,
myodiscs and minus lenticulars, and custom laminate and cemented assemblies. In
addition, raised multifocal lenses need not be tested beyond initial design testing. All of
these types of lenses are required to be made of impact-resistant materials or to be
treated for impact resistance.
Are toy sunglasses subject to the provisions of the regulation?
Yes. Toy sunglasses are subject to the provisions of the Federal Food, Drug, and
Cosmetic Act, and if intended for wear by children, they also are subject to the provisions
of the Federal Hazardous Substances Act, as amended by the Child Protection and Toy
Safety Act of 1969.

SAMPLING PLANS
22. Q.

How does the regulation define the word "batch" as used in the phrase "statistically
significant batch testing?"

A.

The regulation allows each manufacturer to define what constitutes a batch for their
operation, as long as a "batch" is a recognizable or identifiable entity, and appropriate
records are maintained.

23. Q.

Does FDA require manufacturers to use a specific sampling plan when performing
"statistically significant" sampling of lenses?

A.

FDA does not require the use of a specific sampling plan, however, the plan chosen must
be statistically significant. FDA has accepted the use of MIL-STD 105D, April 1963,
"Sampling Procedures and Tables for Inspection by Attributes," Acceptable Quality Level
of 6.5, General Inspection Level II. Another acceptable plan, used by many foreign
manufacturers, is the LTPD 15 percent sampling plan. The sample size is smaller than
MIL-STD 105D with a correspondingly smaller rejection number. Other sampling plans
are acceptable if shown to be statistically significant.
RECORDS

24. Q.

What are the recordkeeping requirements on partially finished lenses furnished by one
manufacturer for completion by another?

A.

Records must be kept to show how lenses were rendered impact-resistant, when and
how they were tested for impact resistance, and by whom in the processing chain these
actions were accomplished.

25. Q.
A.

What records must retailers maintain?

If the retailer is also the manufacturer (see question 12), then the retailer is responsible
for assuring the impact resistance of any lenses processed. The recordkeeping
requirements of the manufacturer apply to the retailer in this case.
In addition, the regulation requires retailers of prescription lenses to keep for 3 years
records of the names and addresses of persons buying impact resistant eyeglasses and
sunglasses. The regulation does not require retailers to keep records of the names and
addresses of people buying nonprescription glasses and sunglasses.

26. Q.
A.

Does the regulation call for coding of invoices, shipping documents, and containers
pertaining to sale and distribution of impact-resistant lenses?
No.

DISPENSING UNTESTED LENSES

27. Q.

Under what circumstances may retailers dispense lenses that are not impact-resistant?
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A.

Lenses that are not impact resistant may be dispensed when a physician or optometrist
determines that impact-resistant lenses will not fulfill the visual requirements of a
particular patient. The physician or optometrist directs this in writing and gives written
notification to the patient.

28. Q.

Can a retailer supply a non-impact-resistant lens if a patient requests it or if the

patient/customer agrees to assume all responsibility?

A.

No. Non-impact-resistant lenses may be provided only when the physician or optometrist
determines that impact-resistant lenses will not fulfill the visual requirements of the
patient. (See question 27.) In such cases the physician or optometrist must give give
notice in writing to the patient, explaining that the patient is receiving a lens that is not
impact resistant.

29. Q.

May a physician or optometrist prescribe nonimpact-resistant lenses for a patient for

purely cosmetic reasons?

A.

No. If medical problems are related to cosmetic considerations, however, the physician
or optometrist may invoke special exemption provisions of the regulation based on
professional judgment. For example, if the patient's prescription cannot be filled by
impact-resistant lenses because the physician or optometrist knows from previous
experience that the weight of the heavy lenses may cause headaches, undue pressure on
the bridge of the nose or ears, pressure sores, etc., the physician or optometrist may find
that the visual requirements of the patient cannot be met by use of impact-resistant
lenses.

30. Q.

Under rare circumstances - such as an emergency in which a surgeon's eyeglasses break

just before a scheduled surgery, and the broken lenses must be replaced immediately may a retailer provide nonimpact-resistant lenses?

A.

If all else fails, and the situation is indeed critical, the surgeon may be provided with
non-impact resistant lenses on a temporary basis only and with the knowledge and
consent of all involved.
FRAMES AND DESIGNS

31. Q.
A.

32. Q.
A.
33. Q.

Does FDA restrict the properties or design of impact-resistant lenses?

The regulation requires only that lenses be made impact resistant and be impact tested.
No other FDA regulations are currently in effect concerning other properties or design of
impact-resistant lenses.

Must rimless eyewear pass the referee test?

Yes. Rimless eyewear must conform to the regulation and pass the referee test or its
equivalent.
Does FDA regulate spectacle frames?
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A.

Yes. Spectacle frames are regulated as medical devices. Spectacle frames are proposed
for classification under 886.5270 as Class II medical devices.
OTHER LENS TYPES

34. Q.
A.

35. Q.
A.

36. Q.
A.

37. Q.

Are safety lenses the same as impact-resistant lenses?

No. Safety lenses ordinarily are used in the industrial setting and are highly impact
resistant, whereas impact-resistant lenses are used in street wear or dress wear
eyeglasses.
Does the regulation apply to industrial safety lenses?
It is not necessary to apply the FDA impact requirement to industrial safety lenses,
because these lenses are required by industrial standards to withstand impact stress
nearly three times greater than the degree of impact resistance required by FDA.
Industrial lenses are regulated by the Occupational Safety and Health Administration of
the Department of Labor.
Are impact-resistant lenses shatterproof or nonbreakable?
Neither. They are impact resistant, in that they are capable of passing the referee test
(drop ball test) as described in the regulation. However, impact-resistant lenses may
break or shatter under certain conditions. Impact-resistant lenses should not be worn in
areas or situations requiring industrial safety lenses.
Are the various forms of goggles or face masks, such as used in skiing, swimming,
snorkeling, etc., subject to the provisions of this regulation?

A.

No. The regulation applies only to eyeglasses and sunglasses; that is, to those products
that are considered medical devices for street wear or dress use.

38. Q.

Must demonstration lenses that are used in eyeglasses and sunglasses for display
purposes be impact resistant?

A.

Demonstration lenses are not required to be impact resistant. However, precautions must
be taken to assure that these display units are not ultimately sold to the consumer.
Manufacturers of eyeglass or sunglass frames with demonstration lenses can use any of
various options to ensure that these units are not used by the public. These options are
listed below.
1. At least one lens in each pair of eyeglasses should have the word
"demonstration" etched in its lower quadrant. The letters should be large enough
to be easily seen with normal vision.
2. A visible line may be drawn through the center of the lens.
3. A notch can be removed from the lower quadrant of at least one lens in each pair
of eyeglasses.
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4. A hole can be drilled in each lens in the wearer's line of sight.

PREMARKET NOTIFICATION
39. Q.

Because spectacle frames and nonprescription sunglasses are common products, must
manufacturers submit a premarket notification 510(k), like other medical device
manufacturers?

A.

Yes, however spectacle frames and sunglass manufacturers should not make complex
premarket notification 510(k) submissions. When submitting the premarket notification
510(k), specifically address the following areas:
For spectacle frames, discuss the material used in its manufacture. If it is plastic, has it
been tested for flammability? What are its dermatological characteristics? How does the
strength and resilience of the proposed material compare to that commonly used?
For sunglasses, discuss whether the product consists of absorbing, reflective, tinted,
polarizing, or photosensitized lenses. If claims are made for reduction of UV
transmission, how was the percentage of reduction determined? Especially for a new
material, how does it respond to drop ball testing?
LIABILITY

40. Q.

What is the personal liability, with regard to injury claims, of a physician, optometrist,
optical retailer, or optical wholesaler under the regulation?

A.

Personal liability should be discussed with an attorney or with professional guilds or

associations and their counsels.

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REFERENCES
1. American National Standards Institute. "Practice for Occupational and Educational Eye and
Face Protection." ANSI Z87.1, New York (1979).
2. American National Standards Institute. "Recommendations for Prescription Ophthalmic
Lenses." ANSI Z80.1, New York (1979).
3. American National Standards Institute. "Sunglasses and Fashion Eyewear." ANSI Z80.3, New
York (1986).
4. American National Standards Institute. "Dress Frames." ANSI Z80.5, New York (1986).
5. U.S. Department of Defense. "Sampling Procedures and Tables for Inspection by Attributes."
MIL-STD-105D. Washington, D.C. (1975).
6. Department of Health, Education, and Welfare. Question and Answer Pamphlet #1 on
Impact-Resistant Lenses. HEW Publication (FDA) 72-4002 (1972).
American national standards can be obtained from the American National Standards Institute,
1430 Broadway, New York, NY 10018.
Military standards can be obtained from the U.S. Naval Publications and Forms Center; 5801
Tabor Avenue, Philadelphia, PA, 19120.

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APPENDIX A. FDA DISTRICT OFFICES

Food & Drug Admin.
1521 W. Pico Blvd.
Los Angeles, CA 90015-2486
Phone: (213) 688-3776
Food & Drug Admin.
50 United Nations Plaza
Federal Office Bldg, #526
San Francisco, CA 94102
Phone: (415) 556-0318
Food & Drug Admin.
500 U.S. Customhouse
721 19th St.
Denver, CO 80202
Phone: (303) 837-4915
Food & Drug Admin.
7200 Lake Ellenor Dr.
Suite 120
Orlando, FL 32809
Phone: (305) 855-0900
Food & Drug Admin.
1010 W. Peachtree St., N.W.
Atlanta, GA 30309
Phone: (404) 881-4266
Food & Drug Admin.
1222 Post Office- Bldg.
433 W. Van Buren St.
Chicago, IL 60607
Phone: (312) 353-7379
Food & Drug Admin.
4298 Elysian Fields Ave.
New Orleans, LA 70122
Phone: (504) 589-2401

Food & Drug Admin.

585 Commercial 6t.
Boston, MA 02109
Phone: (617) 223-5066
Food & Drug Admin.
900 Madison Ave.
Baltimore, MD 21201
Phone: (301) 962-4012
Food & Drug Admin.
1560 E. Jefferson Ave.
Detroit, MI 48207
Phone: (313) 226-6260
Food & Drug Admin.
240 Hennepin Ave.
Minneapolis, MN 55401
Phone: (612) 787-3904
Food & Drug Admin.
St. Louis Station
808 N. Collins St.
St. Louis, MO 63102
Phone: (314) 425-4137
Food & Drug Admin.
1009 Cherry St.
Kansas City, MO 64106
Phone: (816) 374-5521
Food & Drug Admin.
20 Evergreen Pl.
East Orange, NJ 07018
Phone: (201) 645-3023

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Food & Drug Admin.

850 Third Ave.
Brooklyn, NY 11232
Phone: (718) 965-5301
Food & Drug Admin.
599 Delaware Ave.
Buffalo, NY 14202
Phone: (716) 846-4478
Food & Drug Admin.
1141 Central Pkwy.
Cincinnati, OH 45202
Phone: (513) 684-3504

Food & Drug Admin.

Houston Station
1440 North Loop, Suite 250
Houston, TX 77009
Phone: (713) 229-3530
Food & Drug Admin.
909 First Ave.
Room 5003
Seattle, WA 98174
Phone: (206) 442-5304

Food & Drug Admin.

900 U.S. Customhouse
2nd be Chestnut St.
Philadelphia, PA 19106
Phone: (215) 597-3040
Food & Drug Admin.
Fernandez Juncos Ave.,
Stop 81
Puerto de Tierra
San Juan, PR 00905
Phone: (809) 753-4245
Food & Drug Admin.
297 Plus Park Blvd.
Nashville, TN 37217
Phone: (615) 251-5851
Food & Drug Admin.
3032 Bryan St.
Dallas, TX 75204
Phone: (214) 767-0317

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APPENDIX B. VOLUNTARY STANDARDS

The American National Standards Institute (ANSI) standard 280.1, "Recommendations for
Prescription Ophthalmic Lenses," permits the use of a plastic film on top of the lens during the
impact test, as follows:
"To avoid surface damage from the impact of the ball, the lens may be inserted in a
polyethylene bag or covered with a polyethylene sheet before testing. The thickness of
polyethylene covering the lens shall not exceed 0.076 mm (0.003 in.), and shall conform to the
requirements for polyethylene sheeting, Type II, given in ANSI Specification for Polyethylene
Film and Sheeting, ANSI/ASTM D2103, 1971, or the latest revision thereof. The protective
sheet shall be in contact with the lens surface in the test area before the ball is dropped."
FDA agrees to accept this practice when a method of 100 percent testing of finished lenses is
used, although FDA realizes that the impact energy of the falling ball, as transmitted to the lens,
may be reduced by more than 10 percent. FDA still affirms, however, that in any case of dispute,
the referee test as described in 21 CFR 801.410 will prevail. Also, for any new developments in
the materials of lenses, the referee test shall be used in verifying conformance of the new material
to these specifications.
Restriction: When the impact resistance of the lenses is verified by a statistical sampling plan,
FDA insists that the referee test, or its equivalent or superior, be used without the plastic film.

17