USA – FDA Finalizes Combo Product Postmarket Safety Reporting Guidance

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 Abernathy, 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…