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Biomedical Polymers and Compounds™

ISO

FDA and ISO Standards for Medical Devices

The Food and Drug Administration (FDA) requires that medical device manufacturers establish and follow quality systems to help ensure products consistently meet applicable requirements and specifications.  The quality system regulations (QSR) for FDA regulated products are known as current good manufacturing practices (CGMP).  These requirements were first implemented in 1978 under the Federal Food, Drug and Cosmetic Act and defined in section 21 part 820 of the Code of Federal Regulations (21 CFR part 820).

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