2018-05687: Postmarketing Safety Reporting for Combination Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA staff entitled "Postmarketing Safety Reporting for Combination Products." This draft guidance addresses certain means by which applicants may comply with the final rule on postmarketing safety reporting (PMSR) requirements for combination products that FDA issued on December 20, 2016. Combination products are products composed of two or more different types of medical products (drug, device, and/or biological product). Although the PMSR regulations for drugs, devices, and biological products share many similarities, each set of regulations establishes distinct postmarketing reporting requirements, standards, and timeframes. The final rule provides clarity on the PMSR requirements for combination products to ensure consistent and complete reporting while avoiding duplication. This draft guidance is not final nor is it in effect at this time.
The agency’s own summary, as published.
What this changes
Amends 1 part of the Code of Federal Regulations — the standing rules this notice rewrites.
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