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.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.