FDA Publishes Final Rule on Postmarketing Safety Reporting for Combination Products

On December 20, 2016, FDA announced a final rule (Docket No. FDA-2008-N-0424) describing the postmarketing safety reporting requirements when two or more different types of regulated medical products are marketed as a combination product. The new rule is meant to ensure complete postmarketing safety reporting and to avoid duplicative reporting.  The postmarketing safety reporting requirements specific to each constituent part apply to the combination product itself (drugs, devices, and/or biological products, are referred to as the “constituent parts”).  This will benefit public health by ensuring that safety information is appropriately directed to the Agency for a timely review of the information.

The final rule may be read here.

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