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Quality Control Guide for Sunlamp Products (FDA 88-8234) March 1988

Docket Number:
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

Sunlamp products and ultraviolet lamps manufactured on or after May 7, 1980 must conform to applicable portions of a performance standard (21 CFR 1040.20, amended effective September 8,1986), and their manufacture must be in accord with the medical devices Good Manufacturing Practices (GMP) regulations promulgated under the Food, Drug, and Cosmetic Act (FD&C). This guide is intended to assist manufacturers of these products in satisfying both the GMP requirements and in developing and implementing quality assurance (QA) programs. This guide provides the criteria and the underlying philosophy used by FDA to evaluate manufacturers' QA programs.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2020-D-0957.

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