Quality system Regulation - FDA 21 CFR Part 820

FDA 21 CFR Part 820 covers the processes used in, & the facilities & controls used for the design, manufacture, packaging, labelling, storage, installation & servicing of medical devices. Manufacturers are inspected by the US FDA as per Part 820, however, there is no certification process for Part 820 & only compliance with the requirements is assessed.

FDA QSR Compliance for medical device manufacturers

The quality systems for FDA-regulated products (food, drugs, biologics, and devices) are known as Current Good Manufacturing Practices. CGMP requirements for devices in part US FDA 21 CFR Part 820 (21 CFR part 820) were first authorized by section 520(f) of the Federal Food, Drug, and Cosmetic Act, FDA 21 CFR part 820 (QSR 21 CFR part 820 ) is USFDA current good manufacturing (CGMP) requirements for medical device manufacturers. The FDA 21 CFR part 820 also known as Quality System Regulation i.e. FDA QSR which outlines current good manufacturing practise (CGMP) regulations that control the techniques used in and the efficiency and controls used for, the manufacturing, labelling, packaging, storage, installation, design, and servicing of all finished medical devices predetermined for human use and marketing in the United States Of America.

Operon Strategist assists companies and medical device manufacturers by providing consultancy services that support the registration of drug-device combination products.  We have experience with each constituent part and the GMP regulations that together form the basis for their development and manufacture: Drug  (21 CFR 210 and 211), Device (FDA 21 CFR part 820) and Combination Products (21 CFR Part 4).

Read More  -   FDA 21 CFR part 820

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