The quality system regulations are for FDA-regulated products (food, drugs, biologics, and devices) are known as current good manufacturing practices (cGMP’s). It is a quality system that is necessary component of any medical device manufacturer seeking regulatory clearance or approval from FDA to commercialize their product in the US. It is necessary for themanufacturer to meet 21 CFR Part 820 requirements of US Code of Federal Regulations, known as the QSR tobring their products to the US market.
The ISO 13485:2016 and Food and Drug Administration (FDA) QSR 21 CFR 820 have several differences, which is what have kept them from harmonizing in the past.
The US Food and Drug Administration was planning to revise its current Quality System Regulations (QSR) under 21 CFR Part 820 to align with the international standard more closely, ISO 13485:2016. The ISO 13485 quality standard forms the basis for qualitymanagement system requirements in the European Union, Japan, Canada, and other regulated medical device markets. FDA was planning to issue a notice of proposed rulemaking in October 2020 establishing US quality system requirements based more closely on ISO 13485:2016, according to the FDA’s Rule List.
Through the proposed rule, FDA intends to provide less onerous pathways for manufacturers of medical device to the market that currently must meet significant FDA QSR requirements particular to the US to obtain 510(K) premarket notification, De Novo, or Premarket Approval (PMA) registration.
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