FDA Delays Enforcement of Certain Combination Product Reporting Requirements

Posted March 27, 2018

The Food and Drug Administration (FDA) has issued two guidance documents—one final and one draft—intended to clarify the postmarket safety reporting requirements for combination products, which include a medical device and a drug or biological product.

The guidance was developed to provide “greater clarity about the FDA’s postmarket expectations for combination products” and push back enforcement of some provisions of a 2016 final guidance document, which applied to combination products subject to premarket review by the FDA, according to the agency.

In final guidance titled Compliance Policy for Combination Product Postmarketing Safety Reporting, the FDA stated it will delay enforcement of some parts of the 2016 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 final guidance were not affected.

According to this final guidance, the FDA will use the delayed enforcement period to educate combination product applicants on provisions where they are “less familiar” and provide guidance to help them comply; allow combination product applicants “sufficient time to update reporting and recordkeeping systems and procedures, including information technology systems;” and provide time to consider the recommendations of the forthcoming final guidance.

Draft guidance found in Postmarketing Safety Reporting for Combination Products provides instructions to help companies comply with the 2016 postmarket safety reporting final rule. The new guidance explains when and how a single report may be used to meet multiple reporting requirements and submission timelines for a combination product, which can be a challenge because the regulations for components of a combination device may not be entirely the same.

“Combination products, like continuous glucose monitors combined with insulins pumps to act as an artificial pancreas for patients, present significant opportunities for innovation and improvement in patient care. Today’s action will help sponsors comply with important FDA regulations on postmarketing safety reporting for these products process,” 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.”

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.