Dive Brief:

• FDA issued a final guidance Monday clarifying how to comply with a 2016 final rule on postmarketing safety reporting requirements for combination products.
• The document outlines how to submit reports and avoid duplication. It also explains recordkeeping requirements, with examples for both drug and device-led products, including detailed charts showing which content is required in reports under the rule and when they are due to FDA.
• FDA said it will begin to enforce the additional constituent part-based requirements in July 2020 for most combination products and January 2021 for vaccine combination products. AdvaMed had sought a timeframe for implementation of at least two years, per comments on the draft guidance.

Dive Insight:

The past decade has seen a marked increase in development of medical products that combine devices and drugs or biologics, including targeted treatments in which devices deliver particular doses of a drug to a precise part of the body at set times, FDA said.

The new guidance addresses how to comply with reporting requirements for products that have already received FDA marketing authorization. It spells out which products are subject to the final rule and provides hypothetical scenarios illustrating how to comply with various requirements, including reporting triggers and timeframes.

AdvaMed, in comments on the draft guidance, said it agreed with the agency's aim of consistency and streamlining in the process by avoiding duplicative requirements for combination products. The group had sought to have a proposed five-day reporting requirement on adverse events extended to 15 days. It also asked for detailed tables or matrices outlining the requirements and illustrating various scenarios and expectations.

In the final guidance, FDA provides scenarios in which five-day reporting requirements apply to prevent risk of harm to the public.

"Today, the FDA is taking another step to help applicants better comply with important product postmarketing safety reporting requirements and provide us timely, comprehensive safety information about combination products at established intervals," FDA Principal Deputy Commissioner Amy Abernethy said in a statement.

Baxter had commented that the draft initiative to develop a central reporting system for collection of postmarketing safety information for all medical products would help address the added burden and technical difficulties associated with the new reporting regulation.

But Abbott, in its comments on the draft, argued the agency's approach to safety reporting requirements for combination products was confusing due to the various requirements for each component and asked for algorithms to chart the reporting responsibilities under different approval scenarios.