Description
Eyeglasses and sunglasses (eyewear) that are intended to affect the structure or function of the body or intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, are devices within the meaning of section 201(h) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(h)). These devices are subject to applicable device regulations under Title 21, Code of Federal Regulations. Impact-resistant lenses reduce the number of eye injuries from eyeglasses and sunglasses. Glass lenses, plastic lenses, or laminated glass lenses can be made impact resistant by any method. However, lenses generally must be capable of withstanding the impact test described in 21 CFR 801.410.
Scope & Applicability
Product Classes
10Subject of the guidance document
Regulatory classification for spectacle frames and lenses.
Requires registration and listing
Lenses used for retail display, typically not impact resistant.
Regulated as devices requiring impact resistance.
Lenses regulated by both FDA and OSHA.
Regulated as devices under the act
Regulated as devices under the act; Goggles making UV claims are regulated as sunglasses.; Nonprescription ophthalmic devices
lenses that must be tested individually for impact resistance
over-the-counter glass lenses including magnifying spectacles and sunglasses
Stakeholders
8Entity responsible for submitting NDINs
Assists FDA in communications with foreign establishments
The IOR's name, address, and FEI are required for the WEF request.
Considered manufacturers if they perform lens processing.
Must comply with registration if meeting facility/responsible person definitions
Allowed value for reporter qualification
May direct the use of non-impact-resistant lenses; Professional authorized to prescribe nonimpact-resistant lenses.
Entity required to comply with cigarette warning requirements
Regulatory Context
Attributes
4Required property for lenses; property of a lens to withstand physical force
AQL used for determining lot acceptance or rejection
Property required for lenses under 21 CFR 801.410.
characteristic of samples chosen for representative testing
Identified Hazards
Hazards
2Reduced by impact-resistant lenses
risk identified in toys intended for children under 3
Related CFR Sections (9)
- 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 →
- 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 →
- 21CFR886.5844§ 886.5844 Prescription spectacle lens.
(a) Identification. A prescription spectacle lens is a glass or plastic device that is a lens intended to be worn by a patient in a spectacle frame to provide refractive corrections in accordance with a prescription for the patient. The device may be modified to protect the eyes from bright sunlightRead full regulation →
- 21CFR886.5842§ 886.5842 Spectacle frame.
(a) Identification. A spectacle frame is a device made of metal or plastic intended to hold prescription spectacle lenses worn by a patient to correct refractive errors.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 →
- 21CFR807.65§ 807.65 Exemptions for device establishments.
The following classes of persons are exempt from registration in accordance with § 807.20 under the provisions of section 510(g)(1), (g)(2), and (g)(3) of the act, or because the Commissioner of Food and Drugs has found, under section 510(g)(5) of the act, that such registration is not necessary forRead full regulation →
- 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 →
- 21CFR886.5840§ 886.5840 Magnifying spectacles.
(a) Identification. Magnifying spectacles are devices that consist of spectacle frames with convex lenses intended to be worn by a patient who has impaired vision to enlarge images.Read full regulation →
Related Warning Letters (10)
- 2025-12-09
CGMP/QSR/Medical Devices/Adulterated
Envoy Medical Inc.
- 2025-11-25
CGMP/QSR/Medical Devices/Adulterated
Hong Qiangxing Shenzhen Electronics Limited
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated
Contec Medical Systems Co., Ltd.
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Royal Philips
- 2025-10-28
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Qianjiang Kingphar Medical Material Co Ltd.
- 2025-10-21
CGMP/QSR/Medical Devices/Adulterated
LEVO AG
- 2025-10-07
CGMP/QSR/Medical Devices/Adulterated
Technological Medical Advancements LLC
- 2025-09-30
Medical Device Reporting/Misbranded
Insung Medical Co. Ltd.
- 2025-09-23
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
The Richline Group, Inc.
- 2025-09-16
Investigational Device Exemptions (IDE)/Premarket Approval Application (PMA) Adulterated Device
SeniorLife Technologies, Inc.
See Also (8)
- Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- CPG Sec. 130.400 Use of Microfiche and/or Microfilm for Method of Records Retention (Status: Final)
- CPG Sec. 130.300 FDA Access to Results of Quality Assurance Program Audits and Inspections (Status: Final)
- CPG Sec. 300.100 Inspection of Manufacturers of Device Components (Status: Final)
- Device Labeling Guidance #G91-1 (Blue Book Memo) (Status: Final)
- CPG Sec. 310.100 Pacemaker Reuse (Status: Final)
- Variance from Manufacturer Report Number Format - No. 5 (Status: Final)
- Immunotoxicity Testing Guidance (Status: Final)