FDA unveils new guidance extending postmarket safety regulations on some combo products

The FDA unveiled two new draft guidelines, extending post-market safety regulations on some combination products. (Image: FDA)

The FDA set into place two new draft guidelines for device and drug makers that address a final rule from its 2016 postmarketing safety reporting requirements for combination treatments that involve a drug, device and/or biological product.

The first of the new guidelines says the regulatory agency won’t enforce certain requirements under the PSMR final rule so that combination product applicants have enough time to update their reporting and record-keeping systems and procedures technology in order to be compliant with the requirements.

“The draft guidance issued today explains when a single, complete report can be used to meet multiple reporting requirements and what the requirements are for sharing safety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


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The FDA said it doesn’t plan on immediately enforcing parts of the final rule related to constituent part-based PMSR requirements, the submission process for constituent part-based Individual Case Safety Reports, and record-keeping requirements. Those won't be enforced before July 31, 2019 for combination product applicants using the FDA Adverse Event Reporting System and Electronic Medical Device Reporting System to report ICSRs. For combination product applicants using the Vaccine Adverse Event Reporting System to report ICSRs, the rule won't be enforced before Jan. 31, 2020.

However, related to other provisions of 21 CFR Part 4, Subpart B, the agency said it will enforce the requirements for the compliance date provided in the final rule, adding that it will review all comments received and revise the guidance as deemed appropriate.

The other draft guidance addressed how to submit combo product PMSR information to the agency, constituent part-based reporting requirements that apply only to combination product applicants and other information on ICSRs, and streamlining reports for the same event.

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