FDA Announces Enforcement Discretion for Postmarketing Safety Reporting of Combination Products


In an immediately effective guidance document entitled Compliance Policy for Combination Product Postmarketing Safety Reporting (here), the FDA is announcing that it will exercise enforcement discretion for certain safety reporting requirements outlined in the Combination Product Postmarketing Safety Reporting Final Rule issued on December 20, 2016 (81 FR 92603) and codified in 21 CFR Part 4, Subpart B.  The specific provisions covered by this discretionary period are fully outlined in the guidance.

The decision to delay enforcement of specific sections of the Act and previous final guidance document is to ensure that combination product applicants have sufficient time to update their reporting and recordkeeping systems “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.”  All other sections of the Act and final guidance document will be enforced with the exception of the following sections, along with a date for which the enforcement delay is granted.

  • The FDA does not intend to enforce the following provisions of the combination product PMSR final rule applicable to Combination Product Applicants prior to the dates provided in the bullets below: 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)1), and 4.105(b) (recordkeeping requirements).
    • July 31, 2020, for Combination Product Applicants using the FDA Adverse Event Reporting System (FAERS) and Electronic Medical Device Reporting System (eMDR) to report ICSRs.
    • January 31, 2021, for Combination Product Applicants using the Vaccine Adverse Event Reporting System (VAERS) to report ICSRs.

The FDA notably sticks to its timing for the delay of enforcement and, thus, combination product applicants should be certain that they are ready to meet the new compliance dates for the specific section outlined above once those dates arrive.