Guidance Document For Nonprescription Sunglasses - Guidance for Industry

Description

U.S. Department Of Health and Human ServicesFood and Drug AdministrationCenter for Devices and Radiological Health

Scope & Applicability

• 21CFR820.3§ 820.3 Definitions.

  The definitions in ISO 13485 and in Clause 3 of ISO 9000 (incorporated by reference, see § 820.7 ) apply to this part, except as specified in paragraph (b) of this section, and do not affect the meaning of similar terms defined in this title.Read full regulation →

• 21CFR886.5850§ 886.5850 Sunglasses (nonprescription).

  (a) Identification. Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections. This deRead full regulation →

• 21CFR886.9§ 886.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

  The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reasonably foreseeable characteristics of commercially distributed devices within that generic type or, in the casRead full regulation →

• 21CFR807.3§ 807.3 Definitions.

  (a) Act means the Federal Food, Drug, and Cosmetic Act.Read full regulation →

• 21CFR860.3§ 860.3 Definitions.

  For the purposes of this part:Read full regulation →

• 21CFR801.410§ 801.410 Use of impact-resistant lenses in eyeglasses and sunglasses.

  (a) Examination of data available on the frequency of eye injuries resulting from the shattering of ordinary crown glass lenses indicates that the use of such lenses constitutes an avoidable hazard to the eye of the wearer.Read full regulation →

• 21CFR801.1§ 801.1 Medical devices; name and place of business of manufacturer, packer or distributor.

  (a) The label of a device in package form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor.Read full regulation →

• 21CFR801.4§ 801.4 Meaning of intended uses.

  The words intended uses or words of similar import in §§ 801.5 , 801.119 , 801.122 , and 1100.5 of this chapter refer to the objective intent of the persons legally responsible for the labeling of an article (or their representatives). The intent may be shown by such persons' expressions, the designRead full regulation →

• 21CFR801.5§ 801.5 Medical devices; adequate directions for use.

  Adequate directions for use means directions under which the layman can use a device safely and for the purposes for which it is intended. Section 801.4 defines intended use. Directions for use may be inadequate because, among other reasons, of omission, in whole or in part, or incorrect specificatiRead full regulation →

• 21CFR801.6§ 801.6 Medical devices; misleading statements.

  Among representations in the labeling of a device which render such device misbranded is a false or misleading representation with respect to another device or a drug or food or cosmetic.Read full regulation →

• 21CFR801.15§ 801.15 Medical devices; prominence of required label statements; use of symbols in labeling.

  (a) A word, statement, or other information required by or under authority of the act to appear on the label may lack that prominence and conspicuousness required by section 502(c) of the act by reason, among other reasons, of:Read full regulation →

• 21CFR801.60§ 801.60 Principal display panel.

  The term principal display panel, as it applies to over-the-counter devices in package form and as used in this part, means the part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale. The principal display panel shall Read full regulation →

• 21CFR801.61§ 801.61 Statement of identity.

  (a) The principal display panel of an over-the-counter device in package form shall bear as one of its principal features a statement of the identity of the commodity.Read full regulation →

• 21CFR801.62§ 801.62 Declaration of net quantity of contents.

  (a) The label of an over-the-counter device in package form shall bear a declaration of the net quantity of contents. This shall be expressed in the terms of weight, measure, numerical count, or a combination of numerical count and weight, measure, or size: Provided, That:Read full regulation →

• 21CFR801.116§ 801.116 Medical devices having commonly known directions.

  A device shall be exempt from section 502(f)(1) of the act insofar as adequate directions for common uses thereof are known to the ordinary individual.Read full regulation →

• Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA)

  WHOOP, Inc.

  2025-07-15

• CGMP/QSR/Medical Devices/Misbranded

  Wello Inc.

  2023-11-14

• Adulterated and Misbranded Products, including Products Related to Coronavirus Disease 2019 (COVID-19)

  Lexion Medical LLC

  2021-08-03

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