Issue Date: March 1, 1988
Issued by: Center for Devices and Radiological Health
Topic(s): Tanning Lamps, Booths & Beds
Status: Final
Quality Control Guide for Sunlamp Products (FDA 88-8234)
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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