USFDA Periodic Safety Reporting Requirements for Device Constituent Parts in Combination Products


Codresearch

Uploaded on Feb 23, 2026

COD Research is a global clinical research and pharmacovigilance service provider offering end-to-end solutions in Regulatory Affairs, Medical Safety, Drug Safety, and Clinical Operations. We specialize in periodic safety reporting (PSUR, PBRER, PADER, DSUR), signal management, risk management plans (RMP), EVDAS monitoring, and post-marketing surveillance for drugs, biologics, medical devices, and combination products. Our expert team ensures USFDA, EMA, and global regulatory compliance through high-quality documentation, safety reporting, and strategic regulatory support tailored to client needs.

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