The FDA requires manufacturers to conduct post-market surveillance of certain Class II and Class III medical devices. Failure by manufacturers to comply with the FDA requirements under section 522 can lead to harsh enforcement actions. This white paper provides manufacturers with an overview of the FDA’s post-market requirements and helps them understand what the FDA expects when they issue a 522 order.
Final FDA Guidance – Post-Market Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act
White Paper
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