FDA Postpones Enforcement of Combination Product Rules, Outlines Requirements for Constituent Parts

The FDA issued two guidances on postmarketing safety reporting for combination products, pushing back reporting requirements for certain combination products and clarifying reporting rules for their constituent parts.

In one guidance, titled Compliance Policy for Combination Product Postmarketing Safety Reporting, the agency said it will not immediately enforce certain provisions of the 2016 postmarketing safety reporting rule.

The FDA said it will not enforce recordkeeping requirements for combination product applicants who use the agency’s Adverse Event Reporting System and Electronic Medical Device Reporting System before July 31, 2019.