On March 21, 2018, the Food and Drug Administration (FDA) published two guidance documents addressing postmarketing safety reporting requirements (PMSR) for combination products.  The FDA had previously issued a Final Rule on PMSR for combination products on December 20, 2016 (PMSR Final Rule).

By way of background, combination products are therapeutic and diagnostic products that combine drugs, devices, and/or biological products. Because PMSR regulations for medical products in different categories are individualized (for example, PMSR are different for drugs than they are for medical devices and biological products), the two new guidance documents clarify the PMSR requirements that apply when a product is comprised of multiple medical categories. According to the FDA, these documents were issued in an effort to further interpret the Final Rule by ensuring consistent and complete reporting while simultaneously avoiding duplication in reports.

New PMSR Guidance Documents

Compliance Policy for Combination Product Postmarketing Safety Reporting, effective immediately, addresses how to comply with the final rule on PMSR for combination products. In order for the FDA to communicate its compliance in a timely manner given the upcoming compliance deadlines for certain provisions in 21 CFR Part 4, the guidance is effective immediately without comment. The guidance describes the FDA’s compliance policy for combination PMSR for combination applications and constituent party applications and activities under the PMSR Final Rule. According to an FDA Press Release accompanying release of the guidance documents, the FDA does not intend to enforce certain requirements under the PMSR final rule for a period of time to ensure that combination product applicants have sufficient time to update reporting and recordkeeping systems and procedures, including their information technology systems, to comply with the PMSR Final Rule.

Postmarketing Safety Reporting for Combination Products; Draft Guidance for Industry and Food and Drug Administration Staff is a draft guidance document addressing specific means by which applicants may comply with the final rule on PMSR requirements for combination products. The guidance clarifies under what circumstances the criteria for being able to submit a single report to FDA are met that: (1) the reports can be submitted in the same manner and (2) the combined report satisfies all applicable reporting requirements, including submission timelines. According to the FDA, the draft guidance provides clarity on how to meet the PMSR requirements under the PMSR Final Rule, including streamlining opportunities to ensure consistent, timely and complete reporting of adverse events while avoiding unnecessary duplication. It also clarifies how and when co-applicants of combination products must share safety information about a combination product with one another under the PMSR Final Rule.

For more information about what constitutes a combination product, please click here.

This post was co-authored by Chelsea Sousa, legal intern at Robinson+Cole. Chelsea is not yet admitted to practice law.