AAMI News May 2018

FDA Delays Enforcement of Combination Product Reporting Requirements

The Food and Drug Administration (FDA) has issued two guidance documents—one final and one draft—focusing on postmarket safety reporting requirements for combination products, pushing back enforcement of several provisions and seeking feedback on its proposals.

“Today we are issuing guidance to manufacturers on how they can provide more complete and relevant information related to combination products,” said FDA Commissioner Scott Gottlieb in a statement. “We want to make sure that the process for submitting safety information to the FDA is clear, efficient, and promotes timely evaluation of potential safety issues.”

In final guidance titled Compliance Policy for Combination Product Postmarketing Safety Reporting, the FDA stated it will delay enforcement of some parts of a 2016 final rule related to constituent part–based postmarket safety reporting requirements, the submission process for constituent part–based Individual Case Safety Reports (ICSRs), and recordkeeping requirements. The new enforcement deadlines are July 31, 2019, for combination product applicants providing an ICSR using the FDA Adverse Event Reporting System and Electronic Medical Device Reporting System and Jan. 31, 2020, for applicants using the Vaccine Adverse Event Reporting System. Other enforcement deadlines outlined in the 2016 rule were not affected.

According to the guidance document, the agency will use the delayed enforcement period to educate combination product applicants on provisions they are “less familiar” with and provide guidance to help them comply; allow combination product applicants “sufficient time to update reporting and recordkeeping systems and procedures”; and provide additional time for applicants to consider forthcoming recommendations and technical specifics as systems and procedures are updated.

The second guidance document released by the agency in late March, a draft called Postmarketing Safety Reporting for Combination Products, provides instructions to help companies comply with the 2016 rule. The draft guidance explains when and how a single report may be used to meet multiple reporting requirements and submission timelines for a combination product, as well as specifies when and how co-applicants of combination products must share safety information about the product with one another.

The FDA is accepting comments on both documents via www.regulations.gov. Comments on Postmarketing Safety Reporting for Combination Products are due by June 19, 2018.