The FDA issued a new Medical Device Reporting for Manufacturers, describing its current regulation on reporting and record keeping requirements applicable to manufacturers of medical devices for device-related adverse events and certain malfunctions.
These requirements are contained in its Medical Device Reporting (MDR) regulation at Title 21, Code of Federal Regulations (CFR), Part 803, as authorized by section 519 of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations.
The MDR regulation provides a mechanism that allows the FDA to identify and monitor adverse events (deaths and serious injuries) and certain malfunctions involving medical devices. The goal is to detect and correct problems in a timely manner. The requirements of the MDR regulation are enforced under the authority of the FD&C Act. The enforcement mechanisms include seizure, injunction, civil money penalties, and criminal prosecution.
The MDR regulation also includes adverse event reporting and record keeping requirements for medical device user facilities (e.g., a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, outpatient treatment facility), importers of medical devices, and medical device distributors.
Manufacturers, including foreign manufacturers, of legally marketed medical devices in the United States are required to:
- Submit reports of MDR reportable events involving their medical devices [21 CFR 803.10(c) and 803.50];
- 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.
- Establish and maintain complete files for all complaints concerning medical device events.
For manufacturers, “MDR reportable events” are events that manufacturers become aware of that reasonably suggest that one of their marketed devices may have caused or contributed to a death or serious injury, or has malfunctioned and the malfunction of the device or a similar device that they market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur .