After the FDA conducts its premarket review of a medical device, the manufacture and performance of the device are tightly controlled and monitored through a series of postmarket requirements. FDA’s postmarket requirements encompass every aspect of a device’s manufacture – from production and processing to packaging, distribution and use.
Postmarket requirements include adverse event reporting, which provides a mechanism for manufacturers and other stakeholders, including patients, to detect and report potential issues to FDA. Device manufacturers must also establish comprehensive recall procedures so that if a device experiences a serious problem on the market, it can be addressed quickly and effectively. Some higher‑risk products are subject to additional postmarket surveillance and tracking requirements, and manufacturers may be required to conduct postmarket surveillance studies or post-approval studies.
FDA’s Medical Device Reporting (MDR) regulation requires device manufacturers, importers and device user facilities to report certain device-related adverse events and product problems to the FDA. The regulation also requires manufacturers to develop, maintain and implement written procedures for the identification and evaluation of all medical device events (e.g., malfunctions, serious injuries and deaths) to determine whether the event is an MDR reportable event. FDA recently announced a program that permits manufacturers of select medical devices to submit certain device malfunctions on a summary, quarterly basis.
FDA implements a unique device identification (UDI) system to adequately identify medical devices through their distribution and use. At this time, the label of most devices include a UDI in human and machine readable form. Device labelers must also submit certain information about each device to FDA’s Global Unique Device Identification Database (GUDID). Other countries and regions have either implemented UDI requirements or are considering doing so.
We support FDA inspections of regulated medical device facilities to determine their compliance with applicable laws such as the Federal Food, Drug, and Cosmetic Act and its implementing regulations. We share FDA’s goal of efficient inspections that provide FDA with needed information while minimizing the disruption of the inspected facility and preserving FDA and industry resources.