Medical Device Reporting

Although manufacturers and importers of medical devices have been required since 1984 to report to FDA all device-related deaths, serious injuries, and certain malfunctions, numerous reports show widespread under reporting. The Safe Medical Devices Act (SMDA) was brought about in 1990 to increase the information that the FDA and manufacturers receive about serious problems involving medical devices. To implement SMDA, the FDA established the MDR regulations after several amendments.

Medical Device Reporting (MDR) is the mechanism for the FDA to receive reports from manufacturers, importers and user facilities detailing significant medical device adverse events, so they can be detected and corrected quickly. These reports can be of different types, and the user facilities (hospitals, clinics, etc) and manufacturers are required by law to report any significant adverse events or findings.

User Facilities - Should report (i) device related deaths to both FDA and the Manufacturer within 10 days; (ii) device related serious injuries to the manufacturer of the FDA (in case manufacturer is not known) within 10 days. Annual reports of deaths and serious injuries are to be filed to the FDA systematically. In addition, user facilities are to report any information that reasonably suggests that a medical device has caused or contributed to a MDR reportable event and provide all information that is reasonably known to them (no evaluation or investigation is necessary). Records related to an adverse event, whether reported or not, must be kept for two (2) years from the date of the event for FDA access.

Manufacturers - Should submit (i) 30-day reports of deaths, serious injuries or malfunctions to FDA within 30 days of being aware; (ii) baseline report to the FDA to identify and provide basic data on the device being reported (along with 30-day report); (iii) 5-day reports on events that require immediate actions/reforms to FDA within 5 work days. Following the FDA Modernization Act (FDAMA), domestic distributors are not required to file MDR reports, but must maintain complaint files. However, importers must continue to file MDR reports.

Failure to comply with the MDR regulations is a punishable criminal offense and is prohibited under the Food, Drug and Cosmetic Act FD&C Act. The MDR form or the MedWatch 3500A Form is available online and can be filed electronically. To make the process more specific, the FDA has developed a coding manual for completing FDA Form 3500A. The manual contains hundreds of codes for adverse events and will be updated as needed. Most of the MDR information other than trade secrets and financial information are available for public review. As seen, the medical device industry is highly regulated with immense emphasis given to safety and efficacy.