The guidance issued by the US Food and Drug Administration (FDA) explains how combination product manufacturers should comply with post-market safety reporting requirements which were originally established in 2016. It was supposed to be issued in 2018 but got delayed by almost a year. The guidance elaborates on the 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.

The enforcement dates for PMSR are as follows:

  • 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)
  • January 31, 2021 for combination product manufacturers using FDA’s Vaccine Adverse Event Reporting System (VAERS) for reporting on ICSRs.

The two high-level types of entities impacted by this rule are the ​combination product applicants​ (the ones which hold the FDA marketing authorization for combination products) and the ​constituent part applicants​( the ones which hold the registration applications for constituent parts of the combination products). The type of PMSR information the firm is supposed to disclose to the FDA depends on whether it falls under the combination product applicant or the constituent part applicant.

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