Combination Products Get Extra Year for Postmarket Compliance

April 26, 2019

The FDA gave sponsors of combination drug/device products another year to get their IT affairs in order before complying with new postmarket safety reporting requirements.

Companies that make products that would have to report either to the drug or device reporting databases now have until July 2020 to comply with the agency’s December 2016 final rule. Companies that make products related to vaccines have until January 2021.

Last year the agency published a final guidance on the new rule that requires companies that hold the rights to constituent parts of combination products—say, an insulin maker whose product was used in a pump—to file postmarket safety reports. The industry had asked the FDA to clarify the scope of the guidance.

The agency said it delayed enforcement of the rule so companies could build up the information technology infrastructure to comply with the new rules. On Tuesday, the agency extended the deadline even further.

The FDA expects companies to build up “robust IT systems and internal processes” to make sure they are tracking and reporting adverse events for combination products, an agency spokesman told FDAnews.

Read the FDA’s extension notice here: www.fdanews.com/04-23-19-FDAguidance.pdf. — Bill Myers