FDA finalises postmarketing safety reporting requirements guidance for combination products

The United States (US) Food and Drug Administration (FDA) have finalised guidance which details the postmarketing safety reporting (PMSR) requirements for combination products and their constituent parts.

The FDA stated that they have seen a “marked increase in interest from manufacturers who seek to develop medical products that combine devices, drugs and/or biologics” therefore, this guidance aims to help companies increase compliance with important postmarketing safety reporting requirements for products and provide the FDA with comprehensive safety information regarding combination products at established intervals.

The finalised guidance document outlines how combination product manufacturers can comply with the 2016 final rule which established new requirements for submitting safety reports based on all the constituent parts of the product, including application-type reporting.

The FDA have twice pushed back the compliance dates for the safety reporting requirements for constituent parts, the most recent occurred in April 2019 when the FDA states that they do not intend to enforce 21 CFR 4.102(c) and (d) (constituent part-based PMSR requirements), 4.104(b)(1) and (b)(2) (submission process for constituent part-based Individual Case Safety Reports (ICSRs)), and 4.105(b) (recordkeeping requirements) until:

  • 31st July 2020 for combination product applicants using the FDA Adverse Event Reporting System (FAERS) and Electronic Medical Device Reporting System (eMDR) to report ICSRs.
  • 31st January 2021 for combination product applicants using the Vaccine Adverse Event Reporting System (VAERS) to report ICSRs.

The final guidance on the postmarketing safety reporting requirements provides information regarding how combination products are regulated, general considerations for postmarket safety reporting for combination products, information on how and where to submit postmarket safety data to the FDA and what should be included in these reports.

To read the FDA’s guidance on postmarketing safety reporting for combination products, please click here.