FDA Pushes Back Enforcement of Some Postmarket Safety Reporting Requirements for Combo Products

Regulatory NewsRegulatory News | 20 March 2018 |  By 

The US Food and Drug Administration (FDA) on Tuesday released two new guidance documents to help companies address a final rule from 2016 on postmarketing safety reporting (PSMR) requirements for combination products.

One guidance, which is taking effect immediately and is just four pages, notes that FDA does not intend to enforce certain requirements under the 2016 final rule to ensure that combo product applicants have sufficient time to update reporting and recordkeeping systems and procedures, including their IT systems, to comply with the requirements.

Specifically, FDA said it does not intend to enforce portions of the final rule related to constituent part-based PMSR requirements, submission process for constituent part-based Individual Case Safety Reports (ICSRs) and recordkeeping requirements prior to 31 July 2019 for combination product applicants using the FDA Adverse Event Reporting System (FAERS) and Electronic Medical Device Reporting System (eMDR) to report ICSRs, and 31 January 2020, for combo product applicants using the Vaccine Adverse Event Reporting System (VAERS) to report ICSRs.

But for other provisions of 21 CFR Part 4, Subpart B, FDA said it intends to enforce the requirements per its usual policies as of the compliance date provided in the final rule. And although this guidance is immediately in effect, FDA said it will review all comments received and revise the guidance as appropriate.

The other 45-page draft guidance released Tuesday features sections on how to submit combo product PMSR information to FDA, constituent part-based reporting requirements that apply only to combo product applicants and other information on ICSRs, streamlining reports for the same event, as well as hypothetical examples.

FDA Commissioner Scott Gottlieb said in a statement: “The draft guidance issued today explains when a single, complete report can be used to meet multiple reporting requirements and what the requirements are for sharing safety information with co-applicants of a combination product. Combination products, like continuous glucose monitors combined with insulins pumps to act as an artificial pancreas for patients, present significant opportunities for innovation and improvement in patient care."

The Final Rule on Postmarketing Safety Reporting for Combination Products goes into effect 19 July 2018.


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

Draft Guidance: Postmarketing Safety Reporting for Combination Products Guidance for Industry and FDA Staff


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