Post-Market Surveillance

Post-Market Surveillance. The manufacturer shall establish and maintain a post-market surveillance system to proactively collect, analyze, and act upon information about the safety, performance, and quality of marketed products, in accordance with 21 CFR Part 822 (for medical devices), 21 CFR 314.80 (for drugs), and applicable FDA guidance. The post-market surveillance program shall include: (a) systematic monitoring of complaint data, adverse event reports, and Medical Device Reports (MDRs) or MedWatch reports; (b) analysis of product return data, field service reports, and warranty claims; (c) monitoring of published literature, clinical registries, and real-world evidence databases for safety signals related to the product or product class; (d) periodic review of post-market data to identify trends, emerging risks, or changes in the benefit-risk profile; (e) signal detection algorithms and statistical methodologies for early identification of safety concerns; and (f) procedures for implementing corrective actions, including field safety corrective actions, product recalls, or labeling changes, when warranted by post-market data. Post-market surveillance reports shall be submitted to regulatory authorities as required by applicable regulations and within the prescribed timeframes.