FDA published its final combination-product safety-reporting rule on December 20, 2016. Understanding it starts with the application holder, not a generic reference to manufacturers. A combination-product applicant holds the application or applications for the combination product. A constituent-part applicant holds an application for one part where different applicants hold the applications for the constituent parts. [2016-30485][E9-23519]

The products combine two or more different types among drugs, devices and biological products. FDA's October 1, 2009 proposal supplied the reporting rationale: retain the framework associated with the application used for authorization, supplemented for distinctive constituent-part characteristics. The proposal explains the design question; it was not itself an operative final rule. Both documents belong to the same agency process. [2016-30485][E9-23519]

One final provision specifically addressed constituent-part applicants. Section 4.103 requires them to share received information concerning specified deaths, serious injuries or adverse experiences with one another within five calendar days of receipt. The alternative of sharing only with FDA was removed. This change concerns information exchange between applicants, not elimination of their separate obligations to report to FDA. [2016-30485][E9-23519]

The final rule also separated effectiveness from compliance. It specified January 19, 2017 for effectiveness and compliance with existing application-based requirements. Compliance with listed supplementary provisions, including section 4.103, was deferred until 18 months after that effective date. An applicant's identity, the type of obligation and its compliance schedule therefore have to be read together; publication alone did not start every new duty. [2016-30485][E9-23519]

Source documents

  1. Postmarketing Safety Reporting for Combination Productshttps://www.govinfo.gov/content/pkg/FR-2016-12-20/html/2016-30485.htm
  2. Postmarketing Safety Reporting for Combination Productshttps://www.govinfo.gov/content/pkg/FR-2009-10-01/html/E9-23519.htm