The FDA has released final postmarket guidance for manufacturers of drug-device combination products.
The guidance outlines how the agency expects manufacturers of combination products and those that make constituent parts of drug-device combinations to report adverse events and product malfunctions.
Combination-product manufacturers will have five working days to report adverse events that require remedial action to safeguard public health.
Companies whose products fall into the abbreviated new drug application (ANDA), new drug application (NDA) or biologics license application (BLA) marketing categories must submit reports of “serious” and “unexpected” adverse events to the FDA within 15 days of learning of the incident. Manufacturers of drug-device products marketed under a PMA, PDP, HDE, De novo or 510(k) must report such incidents to the FDA within 30 days, the guidance says.
Malfunction reports must be submitted within 30 days. The guidance also covers field alert reporting and correction and removal reporting, information-sharing and recordkeeping requirements and describes methods to streamline reporting.
