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The More the Merrier: Knowing When, Why, and What to Tell FDA About Combination Product Postmarket Events

21 December 2016

Medical Device Alert

The FDA announced yesterday that it is issuing final regulations governing postmarketing safety reporting for combination products. The regulations become effective January 19, 2017, but companies will have until July 19, 2018 to comply with some of the new reporting requirements provided for in the new regulations. The final regulation clarifies reporting requirements for holders of applications covering the whole combination product and holders of applications covering the individual constituents that make up a combination product.

Overall, the final regulation represents a significant transformation in how safety reporting must be handled for combination products. Click here to read more.


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