Postmarketing Safety Reporting for Combination Products

After more than seven years, the US Food and Drug Administration (FDA) issued a final rule on Combo Products.

First proposed in 2009, the rule “Postmarketing Safety Reporting for Combination Products” was introduced to help clarify the postmarket safety reporting requirements for drugs, devices, and biological products when combined to create a combination product. The rule is intended to promote and protect public health and ensure consistent and appropriate postmarket safety reporting for combination products while avoiding duplicate reporting.

To date, the FDA has not issued regulations on postmarket safety reporting for combination products; instead provisions were applied to each constituent part (i.e. reporting requirements specific to drugs, devices or biological products). That practice can result in inconsistent and incomplete postmarket safety reporting for combination products and their constituent parts. Thus, the implementation of the final rule is to ensure complete safety reporting without duplication.

The rule requires manufacturers marketing combination products to comply with the postmarket reporting requirements for the application type of their product such as a new drug application, a biologic license application or premarket approval, as well as the reporting requirements for any constituent parts for their product.

Currently, the FDA only expects manufacturers to comply with postmarket safety reporting requirements for the application type of their product; however, beginning in July 2017, combination product applicants will need to comply with reporting requirements for the constituent parts included in the combination product such as

  • Malfunction reports if the combination product includes a device; or,
  • Field alert reports if it includes a drug.

Moreover, constituent part applicants will be required to share safety reports with each other for applications of the same combination product.

To read the final rule in its entirety:

Postmarketing Safety Reporting for Combination Products