FDA Again Pushes Back Compliance Date for Safety Reporting Requirements for Combo Products

Regulatory NewsRegulatory News | 23 April 2019 |  By 

A little more than a year after pushing back the date by which combination product companies must comply with certain postmarket safety reporting (PMSR) requirements, the US Food and Drug Administration (FDA) on Tuesday extended the compliance deadline again.

The updated guidance explains how FDA does 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:
  • 31 July 2020 for combination product applicants using the FDA Adverse Event Reporting System (FAERS) and Electronic Medical Device Reporting System (eMDR) to report ICSRs.
  • 31 January 2021 for combination product applicants using the Vaccine Adverse Event Reporting System (VAERS) to report ICSRs.
Both dates were pushed back by a year when compared with the previous version of the guidance from March 2018.

“FDA intends to delay enforcement of these provisions to ensure that 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,” the guidance says. “For all other provisions of 21 CFR Part 4, Subpart B, FDA intends to enforce (or continue enforcing) the requirements per its usual policies as of the compliance date provided in the final rule.”

In addition to the application type-based reporting requirements (depending on if parts of the combo product were approved under a new drug application (NDA) or biologics license application (BLA), etc.), the final rule from 2016 requires combination product applicants to submit additional reports based on the constituent parts included in the combination product (e.g., malfunction reports if the combination product includes a device, field alert reports if it includes a drug and biological product deviation reports if it includes a biologic).

In Tuesday’s Federal Register, the agency partly explained why it updated the guidance: “FDA needs to communicate its compliance policy in a timely manner given the compliance deadlines for certain provisions in 21 CFR part 4, subpart B, and the amount of time needed for firms to prepare for them.”

Compliance Policy for Combination Product Postmarketing Safety Reporting: Immediately in Effect Guidance for Industry and Food and Drug Administration Staff


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