Posted by Michael Wonder on 23 Jul 2019
FDA reinforces need for applicants to submit thorough and timely safety information for combination medical products
22 July 2019 - Today, the U.S. FDA released a final guidance, “Post-marketing 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 post-marketing safety reporting requirements for combination products.
Although the post-marketing safety reporting (PSMR) 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, record-keeping requirements, and how to avoid duplications when submitting safety information to the agency.
This final guidance provides examples for both drug and device-led combination products with detailed flowcharts explaining which reports are required under the PMSR rule, and discusses the content for these reports, and when they are due to the FDA.
