Description
The Center for Devices and Radiological Health has found numerous imported and domestic sunlamp products labeled in such a way as to render the label illegible and/or inaccessible to view by the consumer under normal conditions of purchase and use.
Scope & Applicability
Product Classes
1Sunlamp products are electronic products as defined by Section 355(2) [42 U.S.C 263c(2)]
Stakeholders
2Person responsible for establishing FSVP; Person in the United States who owns or has purchased the food at time of entry; entity responsible for FSVP compliance; Entity responsible for FSVP compliance; Entity responsible for conducting hazard analysis; Subject of FSVP requirements for food for humans and animals.; The entity responsible for FSVP compliance and supplier approval.; entity responsible for foreign supplier verification; entity responsible for developing FSVP; entity responsible for
Entity required to conduct postmarket surveillance; entity responsible for submitting postmarket surveillance plans; Entity holding the approved PMA, HDE, or cleared 510(k); The entity responsible for conducting postmarket surveillance and submitting reports.; Entity that can use the checklist as a reference for submissions.
Regulatory Context
Attributes
1Requirement for text and images in submissions.
Related CFR Sections (3)
- 21CFR1040.20§ 1040.20 Sunlamp products and ultraviolet lamps intended for use in sunlamp products.
(a) Applicability.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 →
- 21CFR801.5§ 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 →
See Also (8)
- CPG Sec. 396.400 Policy on Warned on Sunlamp Products (Status: Final)
- CPG Sec. 300.300 Ineffective Devices - 502(f)(I) Labeling Requirements (Status: Final)
- Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203) (Status: Final)
- Guidance Document For Nonprescription Sunglasses - Guidance for Industry (Status: Final)
- Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants - Guidance for Industry and FDA Reviewers (Status: Final)
- Labeling Recommendations for Single-Use Devices Reprocessed by Third Parties and Hospitals: Final Guidance for Industry and FDA (Status: Final)
- Unique Device Identifier System: Frequently Asked Questions, Vol. 1 : Guidance for Industry and Food and Drug Administration Staff (Status: Final)
- Distinguishing Medical Device Recalls from Medical Device Enhancements: Guidance for Industry and Food and Drug Administration Staff (Status: Final)