Quality System Information for Certain Premarket Application Reviews Guidance for Industry and FDA Staff February 2003

GUIDANCE DOCUMENT

• Docket Number: FDA-2020-D-0957
• Issued by: Center for Devices and Radiological Health

Medical device premarket applications submitted under section 515(c)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 360(e)(c)(1)(C)], are required to include a number of information components, as set forth in 21 Code of Federal Regulations (CFR) Sec. 814.20. One component covers the current good manufacturing practice requirements included in the Quality System (QS) regulation. A Premarket Approval Application (PMA) is required to include a complete description of the methods, facilities, and controls, in sufficient detail so that FDA can make a knowledgeable assessment of the quality control used in producing the medical device (21 U.S.C. 515(c)(1)(C)).

This guidance has been prepared by the Center for Devices and Radiological Health (CDRH), in coordination with the Center for Biologics Evaluation and Research (CBER), to assist medical device manufacturers in preparing and maintaining the QS information required in premarket submissions.

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