Final Rule on Postmarketing Safety Reporting Issued by FDA

The FDA has issued a final rule on postmarketing safety reporting requirements as they pertain to combination products. These items may be composed of 2 or 3 constituent parts, such as a medical device and/or a drug and/or a biologic.

The rule builds on the FDA’s ongoing effort to encourage complete postmarketing safety data on various biologic and device products. Both combination product applicants and constituent part applicants are required to comply with postmarketing safety reporting rules, such as sharing safety information with each other and the FDA.

The final rule includes information on what records combination product and constituent part applicants must maintain, as well as how they should submit information to the FDA, specifically, submitting additional reports as needed based on constituent parts. The rules are designed to outline when a single report may suffice, as well as when additional reports must be submitted for instances, such as device correction.

The final rule was first proposed in 2009, and it has been finalized after the review of 16 sets of comments.

This year, the FDA also issued draft guidance on human factors studies and clinical study considerations in combination with product design and development. The administration also provided guidance on implementing human factors, as well as usability engineering to medical devices.