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CFR 21
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7:13
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Medical Device Academy
What is 21 CFR 820?
21 CFR Part 820 is the FDA Current Good Manufacturing Practice (CGMP) regulation which became effective on December 18, 1978. The regulations ensure that medical devices distributed in the US market are designed and developed with adequate procedures, people are trained, and quality records are maintained. In 1990, the FDA revised of the CGMP ...
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