S FDA Regulation for Medical Devices In USA, Medical devices are classified into three categories based on the associated risk, namely: Class I, II and III. Class I devices will have least associated risk while class III devices will have the highest associated risk. Accordingly, regulatory control surges from Class I devices to Class III devices.
Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications.
The quality systems for FDA-regulated products (food, drugs, biologics, and devices) are known as current good manufacturing practices (CGMP’s).
CGMP requirements for devices in part 820 (21 CFR part 820) were first authorized by section 520(f) of the Federal Food, Drug, and Cosmetic Act (the act).
Under section 520(f) of the act, FDA issued a final rule in the Federal Register of July 21, 1978 (43 FR 31 508), prescribing CGMP requirements for medical devices.
This regulation became effective on December 18, 1978, and was codified under part 820. We at Maven Profcon Services provide consultancy in regards to compliance to USFDA, 510K, IEC 60601-1/2/6, IEC 62304, IEC 62366 and ISO 13485.
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