Guidance for Industry
Guidance Document
For
Nonprescription Sunglasses
Document issued on: October 9, 1998
U.S. Department Of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Division of Ophthalmic Devices
Office of Device Evaluation - ii -
  
                            Preface
Public Comment
Comments and suggestions may be submitted at any time for Agency
consideration to David M. Whipple, Associate Director, Division of
Ophthalmic Devices, HFZ-460, 9200 Corporate Blvd., Rockville, MD 20850.
Comments may not be acted upon by the Agency until the document is next
revised or updated.  For questions regarding the use or interpretation of
this guidance contact David M. Whipple at  (301) 594-2205
Additional Copies
World Wide Web/CDRH home page:  http://www.fda.gov/cdrh/ode/sunglass.pdf, or
CDRH Facts on Demand at 1-800-899-0381 or 301-827-0111, specify number 2208
when prompted for the document shelf number. - iii -
  
                       
Table of Contents
Section                                                                                                    Page
Preface --------------------------------------------------------------------------     ii
Introduction -------------------------------------------------------------------     iv
Scope ----------------------------------------------------------------------------     1
Definitions ---------------------------------------------------------------------     1
Regulatory Status
of Nonprescription Sunglasses --------------------------------------     3
Manufacturing Information ------------------------------------------------     3
Label and Labeling Information -------------------------------------------    5
Annex A - Limitations of Exemption
       for Nonprescription Sunglasses --------------------------------------     8
Annex B - Labeling Guidance
       for Nonprescription Sunglasses --------------------------------------    11
Annex C - Bibliography of References
       for Nonprescription Sunglasses --------------------------------------    14 - iv -
  
                                       Introduction
In the United States, nonprescription sunglasses are regulated as medical
devices by the Center for Devices and Radiological Health (CDRH) in the
Food and Drug Administration (FDA).  It is estimated that over 300 million
sunglasses are distributed in this country every year, making them one of the
most widely available over-the-counter ophthalmic devices regulated by
FDA.  In addition, there are hundreds of manufacturers, importers and
distributors of sunglasses who are ultimately responsible for assuring that
the regulatory requirements applicable to nonprescription sunglasses are
being met.  The enclosed guidance document was developed to assist these
individuals in meeting their regulatory responsibilities.
Nonprescription sunglasses are classified and regulated by FDA as class I
devices in accordance with section 886.5850 in Title 21 of the Code of Federal
Regulations (CFR).  Section 206 of the FDA Modernization Act (FDAMA) of
1997 added, among other provisions, section 510(l) to the Act.  This provision
became effective on February 19, 1998.  Section 510(l) states that submission
of a report (i.e., premarket notification) to FDA under section 510(k) is not
required for class I devices unless the class I device is for a use which is of
substantial importance in preventing impairment of human health or
presents a potential unreasonable risk of illness or injury.  FDA does not
believe that nonprescription sunglasses are a type of device that meets the
criteria outlined above for submission of a premarket notification under
section 510(k).  On February 2, 1998, FDA published a notice in the Federal
Register (63 FR 5387) identifying nonprescription sunglasses as a device type
that should be exempt from premarket notification.  The exemption for
nonprescription sunglasses became effective on February 19, 1998.
FDA believes that this deregulation action is appropriate and consistent with
current agency policy for using the least burdensome approach for regulating
medical devices with minimal risks such as those historically associated with
sunglasses.  This deregulation step, however, does not mean that sunglasses
are exempt from any other statutory or regulatory requirements, unless an
order or regulation issued by FDA explicitly provides such exemptions.
Indeed, FDAs determination that premarket notification was unnecessary to
provide a reasonable assurance of safety and effectiveness for
nonprescription sunglasses is based, in part, on the assurances provided by
other regulatory controls.  Nonprescription sunglasses remain subject to
regulations such as those identified as  general controls, which are
applicable to all class I devices, and impact resistant lens requirements.
In addition, there are limitations placed on the exemption of nonprescription
sunglasses, as described in 21 CFR 886.9 and in the February 2, 1998 Federal - v -
  
Register notice.  To avoid unnecessary or inadvertent violations of the Act, the
limitations of the exemption must be clearly understood prior to marketing
sunglasses in the United States without a determination of substantial
equivalence from FDA through the 510(k) process.
FDA is issuing this guidance document for nonprescription sunglasses for
purposes of  (1) informing manufacturers, importers, distributors and other
interested persons of the new regulatory changes affecting these devices; (2)
identifying applicable regulations and voluntary performance standards
associated with the manufacturing and marketing of nonprescription
sunglasses; and, (3) providing guidance on the interpretation of the
limitations of the exemption for Class I devices as it relates specifically to
nonprescription sunglasses.
We hope you find this document to be useful and informative.  We welcome
your comments and requests for further information on the regulation of
nonprescription sunglasses.
A. Ralph Rosenthal, M.D.
Director
Division of Ophthalmic Devices - 1 -
  
Guidance Document
For Nonprescription Sunglasses
I.  Scope:
This guidance is provided to the manufacturers, distributors, importers and
other interested persons to assist them in understanding the regulatory
requirements of the Food and Drug Administration (FDA) that are applicable to
nonprescription sunglasses. This guidance applies to all Class I nonprescription
sunglasses, including clips (clip-ons), that are usually marketed as over-the-
counter (OTC) devices and worn in conjunction with casual or fashion dress and
during general recreational activities.
This guidance does not apply to industrial eyewear, prescription eyewear,
ready-to-wear reading glasses, sport protective eyewear or other forms of
eyewear not defined as nonprescription sunglasses in this guidance.  In addition,
this guidance does not attempt to address additional laws and regulations
enforced by other federal agencies that may also be applicable to
nonprescription sunglasses (e.g. country of origin marking requirements
pursuant to 19 USC Section 1304 of the United States Tariff Act of 1930).
Manufacturers, importers and distributors of nonprescription sunglasses are
expected to be aware of and comply with all laws and regulations, including
those enforced by FDA, that are applicable to their device.
NOTE:  For purposes of this guidance, the terms nonprescription sunglasses
and sunglasses may be used interchangeably.
 
II. Definitions:
This section of the guidance includes terms and definitions that are applicable to
nonprescription sunglasses. This is by no means an all-inclusive list of terms
used within this guidance to describe the regulation of nonprescription
sunglasses.  They are provided as a ready reference source for understanding
and interpreting the information provided in this guidance. [See Annex C-
Bibliography for an informative list of references (e.g., laws, regulations and
standards) that are applicable to nonprescription sunglasses and where relevant
terms and definitions are located].
a.  Manufacturer:  any person who designs, manufactures, fabricates,
assembles, or processes a finished device. The term includes, but is not
limited to, those who perform the functions of contract sterilization,
installation, relabeling, remanufacturing, repackaging, or specification - 2 -
  
development, and initial distributors of foreign entities performing these
functions. [21 CFR 820.3 (o)]
b.  Wholesale Distributor: any person (other than the manufacturer or the
initial importer) who distributes a device from the original place of
manufacture to the person who makes the final delivery or sale of the
device to the ultimate consumer or user.  [21 CFR 807.3 (s)]
c.   Initial Importer: any importer who furthers the marketing of a device
from a foreign manufacturer to the person who makes the final delivery
or sale of the device to the ultimate consumer or user, but does not
repackage, or otherwise change the container, wrapper, or labeling of the
device or device package. [21 CFR 807.3 (g)]
d.  Class I Device: the class of a devices that are subject to only the general
controls authorized by or under Sections 501 (adulteration), 502 
(misbranding), 510 (registration), 5 16 (banned devices), 518 (notification
and other remedies), 519 (records and reports), and 520 (general
provisions) of the Act. [21 CFR 860.3 (c) (1)]
      e.   Nonprescription Device (ophthalmic): an ophthalmic medical device that
is marketed directly to the end user (i.e., consumer) without the need for a
prescription or any other order issued by a licensed eyecare practitioner.
NOTE: Nonprescription devices are commonly sold or distributed as
over-the-counter (OTC) devices. [21 CFR 801 - Subpart C]
f.   Nonprescription Sunglasses: ophthalmic medical devices consisting of
spectacle frames and spectacle lenses or clips (clip-ons) intended for use
in the attenuation of sunlight but not intended to provide refractive
corrections. [21 CFR 886.5850]
g.  Exempt Device (ophthalmic): a type of ophthalmic device that FDA has
granted an exemption from the requirement of premarket notification
under section 510(k) of the Act and  subject to the limitations of
exemptions as described in the Federal Register (FR) announcement dated
February 2, 1998 and titled, Medical Devices; Exemptions from
Premarket Notification and Reserved Devices; Class I. [63 FR 5387]
NOTE:  Ophthalmic devices that are exempt from premarket notification 
[510(k)] can be located in 21 CFR PART 886.
h.  Label:  a display of written, printed or graphic material upon the
immediate container of any device. [Section 201(k) of the Act] - 3 -
  
 i.  Labeling:  all labels and other written, printed or graphic material that is
(1) upon any article (device) or any of its containers or wrappers; (2)
accompanying such article (device) at any time while a device is held for
sale after shipment or delivery for shipment in interstate commerce.
[Section 201(m) of the Act]
III.  Regulatory Status of Nonprescription Sunglasses:
Nonprescription sunglasses are:
a.  described in 21 CFR Section 886.5850  as devices that consist of spectacle
frames or clips (clip-ons) with absorbing, reflective, tinted, polarizing or
photosensitizing lenses intended to be worn by a person to protect  the
eyes from bright sunlight but not to provide refractive corrections;
b.  classified as Class I medical devices (product code HQY) and regulated
under the general controls provisions of the Act; and,
 c.  exempt  from the requirement of premarket notification [510(k)] effective
February 19, 1998 in accordance with Section 206 of the FDA
Modernization Act (FDAMA) of 1997.  In addition, nonprescription
sunglasses are subject to the limitations of exemptions as described in the
Federal Register notice dated February 2, 1998 and titled, Medical
Devices; Exemptions from Premarket Notification and Reserved Devices;
Class I. [63 FR 5387]
NOTE:  Sunglasses that do not meet the criteria for compliance with the
limitations of exemptions must submit a 510(k) and receive a
determination of substantial equivalence from FDA before marketing the
device (See Annex A for Guidance on the Limitations of Exemptions for
Nonprescription Sunglasses).
IV.  Manufacturing Information:
When establishing finished product specifications for sunglasses, manufacturers
should assess the following physical, chemical, optical and toxicological
properties of the major components (i.e., spectacle frames and/or spectacle
lenses) used in the manufacturing of the finished device:
a.   Impact Resistance: Sunglasses shall be fitted with impact-resistant lenses.
Impact-resistant lenses must comply with FDA requirements set forth in
21 CFR 801.410, Use of Impact Resistant Lenses in Eyeglasses and
Sunglasses. - 4 -
  
NOTE:  Use of the words must and shall is appropriate in a voluntary
guidance when a manufacturer is ordered to comply with a requirement
established by law or regulation.
b.  Flammability:  Sunglasses should be manufactured from finished
materials that are nonflammable as defined in the Federal Hazardous
Substances Act [15 U.S.C. 1261 (f)].  Meeting the flammable solids
requirements of 15 USC 1261~1, 1263 and 16 CFR 1500.44 would be
considered adequate for purposes of addressing this specification.
 
c.   Biocompatibility:  Sunglasses should be manufactured from finished
materials that are non-toxic, non-irritating, nor capable of producing
allergic reactions to a significant degree under normal conditions of use.
 
d.  Optical Properties: Sunglasses should be manufactured with plano
spectacle lenses designed to attenuate sunlight and provide the optical
characteristics or properties as stated in the labeling, advertising, or
promotional materials for the device (e.g., polarizing, ultra violet (UV)
blocking, tinted, reflecting. etc.)
Conformance with the requirements of the following voluntary national or
international standards, e.g., American National Standards Institute (ANSI),
International Organization of Standards (ISO), is considered acceptable for good
manufacturing practices and appropriate for use in evaluating the critical design
characteristics and properties listed above.
a.  Impact Resistance:  ANSI Z80.3-1996, Nonprescription Sunglasses and
Fashion Eyewear - Requirements, Section 5.1- Impact Resistance Test
b.  Flammability:  ANSI Z80.3-1996, Nonprescription Sunglasses and Fashion
Eyewear - Requirements Section 5.3 - Flammability Test
c.   Biocompatibility:  ISO 10993, Biological  Evaluation of Medical Devices -
Parts 1-12 - 5 -
  
d.  Optical Properties:
   ISO 14889, Ophthalmic Optics - Fundamental Requirements for Uncut
Spectacle Lenses, Section 4.5.
   ISO 8980 - 3, Ophthalmic Optics -Uncut Finished Spectacle Lenses -
Part 3, Transmittance Specifications and Test Methods.
   ANSI Z80.3 - 1996, Nonprescription Sunglasses and Fashion Eyewear -
Requirements, Sections 4.4 through 4.8.
NOTE 1: The standards cited under Optical Properties (Subsection d)
above may be used to determine refractive properties, transmittance
properties including traffic signal recognition and other optical properties
identified within these standards that may be applicable to the design of
the device.
NOTE 2: Traffic Signal Recognition provisions contained in ANSI Z80.3
were developed with the color defective person in mind.  Approximately
8% of the male population and less than 3% of the female population have
some type of color deficiency. Therefore, some of the requirements of this
section of the standard may be overly stringent for color normal
individuals.
V.  Label and Labeling Information:
The terms label and labeling are related but not interchangeable. The term
label is more restricted in scope and generally consists of the part of the
display that is confined to the device itself.  The term labeling is much broader
in scope and consists of the label on the devices as well as the descriptive and
informational literature that may accompany the device, or may come together at
the devices point of display.  The following is a list of labeling regulations that
are generally applicable to nonprescription sunglasses.
a.  General Labeling Requirements:
Nonprescription sunglasses are generally marketed as OTC medical
devices and are subject to the following general labeling and OTC
labeling requirements outlined in 21 CFR Part 801 - Labeling: - 6 -
  
(1)  Subpart A - General Labeling Provisions:
   Sec. 801.1   - Name and Place of Business;
   Sec. 801.4   - Intended Uses
   Sec. 801.5   - Adequate Directions for Use
   Sec. 801.6   - False and Misleading Statements
   Sec. 801.15 - Prominence of Labeling Statements
(2)  Subpart C - Labeling Requirements for Over-the-Counter Devices
   Sec. 801.60 - Principal Display Panel
   Sec. 801.61 - Statement of Identity
   Sec. 801.62 - Declaration of Net Quantity
(3)  Subpart D - Exemptions from Adequate Directions for Use
   Sec. 801.116 - Medical Devices Having Commonly Known
Directions
(4) Subpart H - Special Requirements for Specific Devices
   Sec. 801.410 - Use of Impact Resistant Lenses in Eyeglasses and
Sunglasses
        b.  Adulteration Laws:
Section 501of the Act contains provisions defining adulteration of
devices.  Specifically, 501(c) states a device is adulterated if its quality
falls below that which it purports or is represented to possess.  Violations
may include non-compliance with an applicable regulation (e.g., non-
compliance with impact resistant lens regulations), non-conformance
with an applicable standard for which conformance is claimed (e.g., non-
conformance with traffic signal recognition provisions of ANSI Z80.3
when conformance is stated or implied in the labeling) or any other
implied or stated labeling claim that would cause the device to be
adulterated within the meaning of Section 501 of the Act (e.g., claims
made by the manufacturer in the labeling for their sunglasses that claim
they are constructed of lenses that block 100% UVA, UVB & UVC if such
statements are untrue with respect to the sunglasses in question). - 7 -
  
   c.  Misbranding Laws
Section 502 of the Act contains provisions on misbranding and false or
misleading labeling for medical devices.  Specifically, section 502(a)
declares that a device is misbranded if its labeling proves to be false or
misleading in any particular.  Historically, OTC devices, such as
sunglasses, are at risk for violations of this law because they are
generally marketed directly to consumers. Violations of this law are not
confined to strict interpretations of statements that are untrue, forged,
fraudulent or deceptive. It may also include labeling that creates a false
impression in the mind of a consumer.  Examples of false or misleading
labeling includes:
   unsubstantiated claims of therapeutic value;
   ambiguity, half-truths, and trade puffery;
   failure to reveal a material fact;
   inadequate, incomplete, or inaccurate statements
   deceptive pictorial matter
To avoid unnecessary or inadvertent violations of the Act, all promotion,
labeling and advertising material should be carefully reviewed to insure
compliance with the labeling laws and regulations applicable to nonprescription
sunglasses (See Annex B for additional labeling guidance on intended use,
performance claims, and directions for use specifically relating to
nonprescription sunglasses).
Annex A - 8 -
  
 Limitations of Exemption for Nonprescription Sunglasses
Nonprescription sunglasses were granted an exemption from the requirement of
premarket notification under section 510(k) of the Act on February 19, 1998.  In
addition, they are subject to the limitations of exemptions as described in 21 CFR
886.9 and in the February 2, 1998 Federal Register (FR) announcement titled,
Medical Devices; Exemptions from Premarket Notification and Reserved
Devices; Class I. [63 FR 5387]
As previously stated in the cover letter of this guidance, Section 206 of the FDA
Modernization Act (FDAMA) of 1997 added, among other provisions, section
510(l) to the Act.  Section 510(l) states that submission of a premarket notification
report to FDA under section 510(k) is not required for a class I device unless the
device is for a use which is of substantial importance in preventing impairment
of human health or presents a potential unreasonable risk of illness or injury,
hereafter referred to as reserved criteria.  FDA does not believe that
nonprescription sunglasses are a type of device that meets the reserved criteria
outlined above to require the submission of a premarket notification report
under section 510(k).  Therefore, on February 2, 1998, FDA published a notice in
the Federal Register identifying nonprescription sunglasses as a device type that
should be exempt from premarket notification.  The exemption for
nonprescription became effective on February 19, 1998.
FDAs decision to grant an exemption from the requirements of premarket
notification for a generic type of device, such as sunglasses, is based upon
existing and reasonably foreseeable characteristics of these devices.  However,
FDA cannot anticipate every change in the intended use of a device that is of
substantial importance in preventing impairment of human health or changes in
the device characteristics that significantly affects the safety or performance of
the device as to present a potential unreasonable risk of illness or injury as
described in the reserved criteria. Therefore, manufacturers of devices for which
FDA has granted an exemption from premarket notification requirements must
still submit a premarket notification [510(k)] to FDA and receive a substantial
equivalence determination before introducing the device into interstate
commerce for commercial distribution when:
a. The device has an intended use that is different from the intended uses of
legally marketed devices in the generic type of device; e.g., a device that
is intended for a different medical purpose, or a device that is intended
for lay use instead of use by health care professionals; or,
 b.  The device has been modified to operate using a different fundamental
scientific technology that differs from those used by legally marketed - 9 -
  
devices in that same generic type of device, e.g., a surgical instrument
that cuts tissue with a laser beam rather than with a sharpened metal
blade.
Any class I device incorporating such changes or modifications is no longer
considered exempt from premarket notification because FDA believes they
would meet the reserved criteria described in section 510(l) of the Act.
The following examples provided below are presented to help illustrate FDAs
interpretation of the limitations of exemptions as it specifically relates to
nonprescription sunglasses.
Example 1 - FDA has previously cleared for marketing nonprescription
sunglasses for use in relieving eye strain and eye fatigue due to glare
from exposure to bright sunlight.  FDA would consider manufacturers
making similar types of sunglasses with a similar type of claim to be
within the limitations of the exemption and no premarket notification
[510(k)] would be required prior to placing the sunglasses into
commercial distribution.  Manufacturers are reminded, however, all
claims must be supported by valid scientific evidence regardless of the
need for submission of a 510(k).
Information supporting any marketing claims should be maintained by
the manufacturer in the appropriate records for the device.
Example 2 - A manufacturer of sunglasses wants to make health related
or other performance claims in their labeling that have not been
previously cleared by FDA in a 510(k).  These claims may include
statements such as, "...for protection against the formation of cataracts..."
or "...for prevention of cataracts and other ocular disorders...",
"...improves visual acuity...", or  "...for use in the treatment of color
blindness...".  Such statements would be considered claims of intended
uses that are different from the legally marketed devices of that generic
type. Therefore, sunglasses making such claims would not be exempt
from premarket notification because they would met the reserved criteria
described above, under section 510(l) of the Act.
The above examples are provided as guidance for interpretation of the
limitations of exemptions as it specifically applies to nonprescription sunglasses.
Past experience has demonstrated, however, that manufacturers of devices that
have been granted an exemption from premarket notification [510(k)]
submission requirements often assume they have achieved a greater degree of
deregulation than the exemption affords.  FDA advises that an exemption from
the requirements of premarket notification does not mean that the device is
exempt from any other statutory or regulatory requirements, unless FDA issues - 10 -
  
an order or regulation that explicitly provides such exemptions.  Therefore, it is
extremely important that all parties involved in the manufacturing and
distribution of nonprescription sunglasses become thoroughly familiar with the
limitations of exemption and with the other general controls that are applicable
to all Class I devices. Familiarity with the laws and regulations applicable to
nonprescription sunglasses will help manufacturers meet their regulatory
responsibilities and avoid unnecessary or inadvertent violations of the Act.
In the past, FDA has taken exception to certain unsubstantiated performance
claims or new intended uses, such as those relating to UV absorbing sunglasses,
that have appeared in promotion, labeling and advertising from several
manufacturers. Warning letters have been issued by FDA to manufacturers
advising them that commercial distribution and promotion of a device with
unsubstantiated claims and without the benefit of a determination of substantial
equivalence through the 510(k) process may result in the adulteration of the
device within the meaning of Section 501 and misbranding of the device within
the meaning of Section 502 of the Act.
It is ultimately the responsibility of the manufacturer to determine if new or
modified type of sunglasses meets the criteria for exemption from submission of
a 510(k) prior to marketing and distribution in the United States.  If a
manufacturer is uncertain as to the regulatory status of their new or modified
sunglasses, please contact the Division of Ophthalmic Devices, at the phone
numbers previously provided in this document, for further advice and guidance
relating to the limitations of exemptions for nonprescription sunglasses.
                                                    Annex B - 11 -
  
               Labeling Guidance for Nonprescription Sunglasses
Intended Use and Performance Claims:
Sunglasses are intended for use in the attenuation of bright sunlight.  They are
generally worn with casual or fashion dress, while driving during daylight or
while participating in general recreational activities.
Sunglasses manufactured with reflective, tinted, polarizing, photosensitizing
lenses and meet ISO 8980 - 3 or ANSI Z80.3 for UV and visible light
transmittance requirements, may also be indicated for use in protecting the eyes
from exposure to bright sunlight including its UV component. The degree to
which sunglasses will attenuate sunlight and block UV varies with the physical,
chemical and optical properties of the lenses.  Therefore, the performance claims
found in the promotion, labeling or advertising for sunglasses may vary
according to its construction.  The following are examples of statements of
intended use and performance claims that are adequate for labeling of
nonprescription sunglasses:
a.  Sunglasses that meet UV requirements of Table 4 of ANSI Z80.3-1996 may
be labeled as follows:
     ...lenses meet ANSI Z80.3 1996 [normal] or [strictest] UV blocking
requirements .
     Additional optional language:  ...lenses block [X]%UVB and [Y]%UVA.
b.  Sunglasses constructed with absorbing, reflective, tinted, polarizing or
photosensitizing lenses attenuate light and reduce glare.  Therefore,
sunglasses may be labeled with a claim such as:
     "...may reduce eye strain and/or eye fatigue due to glare".
c.  Sunglasses that meet the FDA impact resistance requirements may be
labeled with statements such as:
     "...lenses meet applicable government impact resistance requirements but
ARE NOT SHATTERPROOF".
d.  Sunglasses intended for driving should pass the requirements specified in
ISO-14889, section 4.5 or ANSI Z80.3-1996, section 4.6.3, and may be
labeled accordingly.  Sunglasses that do not meet either of these
requirements should be labeled: - 12 -
  
"CAUTION: not for use while driving."
Directions for Use:
OTC nonprescription sunglasses can usually be marketed without
comprehensive directions for use because their common uses are generally
known to the ordinary individual (21 CFR 801.116).  However, manufacturers
may choose to include a section in their labeling to provide information on
selection and use criteria for their sunglasses.  An example of selection and use
criteria are illustrated below:
a.   Sunglasses are required by federal law to be impact resistant, but they are
not shatterproof nor are they an unbreakable shield. They are not
intended to function as impact protective eyewear for use in high-risk
impact sports or for industrial safety uses.
b.   Choose a lens shade with a relationship to use.  Generally speaking, in
and around town, the more cosmetic or light to medium tints are worn;
while on the beach or skiing darker shades are worn.  Ultimately, the
amount of light a lens should transmit relates to the brightness of the
environment and individual comfort.
c.   In selecting sunglasses, test the optical quality of the lens by putting on
the sunglasses and viewing a vertical edge or line. Do this by moving
your head back and forth allowing your eyes to sweep across the lens. If
there is any wiggle in the line, then the lens may have an optical defect
and you should choose another pair.
d.   The frame should fit comfortably and allow the lens to be positioned
directly in front of the eye.
e.   If you are uncertain that the sunglasses you intend to purchase meet
traffic signal recognition requirements, read the labeling to determine if
there are statements recommending that the sunglasses should not be
worn while driving.
In addition, manufacturers may choose to include public service reminders of
commonly understood risks associated with the misuse of sunglasses. Suggested
reminders may include the following:
a.   Tinted eyewear is not recommended to be worn for night driving.
b.   Sunglasses are not intended for use as protection against artificial light
sources, such as sun lamps, lasers, etc. - 13 -
  
c.   Sunglasses are not recommended for high-risk impact sports participants.
d.   Sunglasses are not intended for use as industrial safety eyewear.
e.   Never stare directly at the sun or at an eclipse with or without sunglasses.
  f.   Lenses in sunglasses must meet applicable federal requirements for
impact resistance but they ARE NOT SHATTERPROOF. - 14 -
  
                                                            Annex C
      Bibliography of References for Nonprescription Sunglasses
Laws and Regulations:
   Code of Federal Regulations (CFR) Section 1500 44 (Flammability
Requirements) (1998).
   Sections 501 (Adulterated Devices), 502 (Misbranded Devices), 510
(Registration), 510(k) (Premarket Notification), 516 (Banned Devices), 518
(Notification and Recall of Defective Devices), 519 (Device Reporting), and
520 (General Provisions, Good Manufacturing Practices) of the Federal Food,
Drug and Cosmetic Act (FD&C Act), codified at 21 United States Code (USC)
Sections 351, 352, 360, 360f, 360h, 360i and 360j, respectively.
   Section 206 of the FDA Modernization Act (FDAMA) of 1997 (amending
Section 510(k) of the FD&C Act), PL. 105-115, 111 Stat. 2296, 2338, (Nov. 21,
1997).
   21 CFR 801.1 to 801.16 (General Labeling Provisions), 801.116 (Labeling
Exception), 801.410 (Impact Resistance "Drop Ball" Test), 807.20 (Registration
and Listing), 820.3 (Quality System/GMP Requirements), 820.120 (Labeling
Procedures), 886.9 (Limitations on 510(k) Exemptions), 886.5850
(Classification Regulation for Nonprescription Sunglasses) (1998).
   Sections 2 and 4 (Flammability Requirements) of the Federal Hazardous
Substances Act codified at 15 USC Sections 1261 (f) and (l) and 1263,
respectively.
   Medical Device Amendments Act, PL. 94-205, 90 Stat. 579 (May 28, 1976).
   Section 304, Tariff Act of 1930, codified at 19 USC Section 1304 (Country of
Origin Marking).
   Notice, Medical Devices; Exemptions From Premarket Notification and
Reserved Devices; Class I, 63 Federal Register 5387 (February 2, 1998). - 15 -
  
Voluntary National and International Standards:
   ANSI Z80.3-1996, Ophthalmic - Nonprescription Sunglasses and Fashion
Eyewear Requirements.
   ISO 8980-3, Ophthalmic Optics - Uncut Finished Spectacle Lenses - Part 3 -
Transmittance Specification and Test Methods.
   ISO 14889, Ophthalmic Optics - Spectacle Lenses - Fundamental
Requirements for Uncut Finished Lenses.
   ISO 10993, Biological Evaluation of Medical Devices - Parts 1 through 12.