US FDA Extends Safety-Reporting Deadline For Certain Combination Products, Issues Guidance

22 Mar 2018

After issuing a major combination product post-market safety reporting rule at the end of 2016, US FDA released guidance to add context for companies developing the products. The agency has also extended compliance deadlines in many cases until 2019.

US FDA is giving companies more time to comply with elements of a 2016 combination product reporting requirement rule while issuing guidance to help implement the rule.

Specifically, the agency published a draft guidance and a separate, effective-immediately final guidance on reporting requirements for combination products outlined in the earlier rule.