Postmarketing Safety Reporting for Combination Products Final Rule Effective January 19, 2017

Last month we reported that FDA Publishes Final Rule for Postmarketing Safety Reporting for Combination Products. This month, we wish to remind you that it has taken effect. The new rule “describes the postmarketing safety reporting requirements that apply when two or more different types of regulated medical products (drugs, devices, and/or biological products, which are referred to as “constituent parts” of a combination product) comprise a combination product and the combination product or its constituent parts have received FDA marketing authorization” (81 FR 92603) and may be found here.  The final rule, first proposed in 2009, may be viewed here (74 FR 50744).  For a story from RAPS on the topic, click FDA Issues Long-Awaited Final Rule on Combo Product Postmarket Safety, or here to learn more about combination product development.

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