FDA Finalizes Combo Product Postmarket Safety Reporting Guidance

Regulatory NewsRegulatory News | 22 July 2019 |  By 

The US Food and Drug Administration (FDA) on Monday finalized guidance explaining postmarket safety reporting (PMSR) requirements for combination products and their constituent parts.
"In the past decade we have seen a marked increase in interest from manufacturers who seek to develop medical products that combine devices, drugs and/or biologics,” said FDA Principal Deputy Commissioner Amy Abernethy, noting that the newly finalized guidance will “help applicants better comply with important product postmarketing safety reporting requirements and provide us timely, comprehensive safety information about combination products at established intervals.”
Specifically, the 44-page guidance addresses how combination product makers can comply with a 2016 final rule that established new requirements for submitting safety reports based on all the constituent parts of the product in addition to application-type reporting.
The final rule also established that the makers of constituent parts must share certain postmarket safety information with one another.
The final guidance comes after FDA twice pushed back compliance dates for the safety reporting requirements for constituent parts, most recently in April 2019 when the agency said it 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.
While the final guidance does not mention the enforcement dates, a page on FDA’s website marked current as of 22 July leaves those dates intact.
The final guidance itself is broken up into sections providing background information about the guidance and how combination products are regulated; general and specific considerations for postmarket safety reporting for combination products; details on how and where to submit postmarket safety information to FDA and what data should be included in those reports.
The guidance also includes two hypothetical examples of postmarket safety reporting considerations for combination products. The first example follows a product marketed under a new drug application comprised of an injectable drug in a sterile pre-filled syringe and the second involves a drug-eluting stent marketed under a premarket approval application.
FDA, Federal Register Notice


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