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FDA Settles Safety Report Requirements for Combination Products after Seven Years

January 6, 2017

The type of postmarket safety report required for a combination medical product will be based on whether the product was approved through a drug, biologic, or device application, according to the FDA’s final rule published today.

Additional reports will be based on the constituent parts of the combination product. These include malfunction reports if the product includes a device, field alert reports in the case of a drug — or biological product deviation reports, as suggested by public comments following the rule’s initial proposal in 2009.

Sponsors are not required to submit more than one report, the agency said, as long as the single report contains all required information and meets applicable deadlines.

The rule largely goes into effect Jan. 20, 2017, as many duties for both combination product and constituent part applicants are generally the same for any application holder already in compliance. Additional reporting requirements based on individual product components will take effect in July 2018.

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