FDA In Brief: FDA reinforces need for applicants to submit thorough and timely safety information for combination medical products

https://www.fda.gov/news-events/fda-brief/fda-brief-fda-reinforces-need-applicants-submit-thorough-and-timely-safety-information-combination?utm_campaign=072219_FIB_FDA%20reinforces%20need%20to%20submit%20timely%20combination%20products%20safety%20info&utm_medium=email&utm_source=Eloqua

FDA In Brief: FDA reinforces need for applicants to submit thorough and timely safety information for combination medical products

Today, the U.S. Food and Drug Administration released a final guidance, “Postmarketing Safety Reporting for Combination Products,” for applicants of combination products—products composed of two or more different types of medical products (i.e., drug, device or biologic)—to further clarify how they can comply with the 2016 final rule on postmarketing safety reporting requirements (PMSR) for combination products. Although the PMSR regulations for drugs, devices and biological products have many similarities, each set of regulations establishes distinct safety reporting requirements, including standards and timeframes. This final guidance explains, among other things, which combination products are impacted by the PMSR requirements, how to submit reports, recordkeeping requirements, and how to ...

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