Aug 1, 2019

Final guidance issued by the US Food and Drug Administration explains how combination product manufacturers should comply with post-market safety reporting requirements originally established in late 2016.

The final guidance, issued after delays in 2018 and earlier in 2019, clarifies post-market safety reporting (PMSR) requirements as they pertain to medical device, drug and biological product components of combination products, as well as recommended means by which manufacturers may comply with PMSR rules. According to April 2019 guidance from FDA on PMSR policies for combination products, enforcement dates for PMSR rules are now:

  • July 31, 2020 for combination product manufacturers that use either the FDA Adverse Event Reporting System (FAERS) and/or Electronic Medical Device Reporting System (eMDR) to report individual case safety reports (ICSRs), and
  • January 31, 2021 for combination product manufacturers using FDA’s Vaccine Adverse Event Reporting System (VAERS) for reporting on ICSRs.

FDA has pushed out these compliance deadlines by one year from its previous timeframe set in 2018.

Manufacturers impacted by PMSR reporting rules

The final guidance establishes two high-level types of entities that will have to comply with PMSR requirements: combination product applicants, which hold all FDA marketing authorization applications for a combination product; and constituent part applicants, which hold registration applications for only constituent parts of combination products—i.e., one such entity may hold a Premarket Authorization (PMA) for the laser system component of a combination product, while another entity would hold the New Drug Application (NDA) for the light-activated drug component of that product, according to the final guidance.

“A company is a Constituent Part Applicant only if that entity hold an application to market that product as a constituent part of a combination product,” FDA states in the guidance.

Types of PMSR requirements

Which types of PMSR information a manufacturer must provide to FDA depends on whether that firm qualifies as a combination product applicant or a constituent part applicant. The guidance lists several reporting requirements and how they apply:

  • Application type-based reporting requirements pertain to both combination product and constituent part applicants;
  • Constituent part-based reporting requirements apply only to combination product applicants;
  • Information sharing rules require constituent part applicants to share post-marketing safety data they receive with one another;
  • Submission process rules lay out requirements whereby both combination product and constituent part applicants must submit PMSR data to FDA;
  • Streamlined reporting rules indicate how to meet multiple reporting requirements using a single report;
  • Records retention rules identify which records applicants are required to maintain, and for how long.

In addition, the guidance identifies various types of post-market safety reporting combination product manufacturers will be expected to provide to US regulators, including ICSRs, field alert reports, biological product deviation reports, and correction and removal reports.

Related US FDA regulatory information from Emergo by UL:

  • FDA eMDR adverse event reporting support
  • Webinar: Human factors engineering for combination products