FDA further delays compliance date for postmarketing safety reporting requirements for combination products

After pushing back the date by which combination product companies must comply with certain postmarketing safety reporting (PMSR) requirements, the United States (US) Food and Drug Administration (FDA) have further delayed the compliance deadline by a year.

The updated guidance outlines how the FDA is not planning 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 FDA have delayed enforcement of these provisions to ensure combination product applicants “have sufficient time to update reporting and recordkeeping systems and procedures, including their information technology systems, to comply with these requirements, and in doing so, have sufficient time to consider the recommendations and technical specifications that FDA intends to provide through guidance to support compliance.”

An additional requirement to the application type-based reporting requirements (depending on whether parts of the combination product were approved under a new drug application (NDA) or biologics license application (BLA)), is the final rule from 2016. Combination product applicants are required to submit additional reports based on the constituent parts included in the combination product, for example malfunction reports if the combination product includes a device and field alert reports if the product includes a drug.

To read the FDA’s compliance policy for combination product postmarketing safety reporting, please click here.