The US Food and Drug Administration (FDA) has released final guidance for reporting and record-keeping requirements applicable to manufacturers of medical devices for device-related adverse events and certain malfunctions. The FDA says the purpose of the updated document – which supersedes the medical device reporting guidance dated March 1997 – is to detect and correct problems promptly, as mandated by the Federal Food, Drug and Cosmetic Act (FD & C Act).
All medical device manufacturers in the United States, including foreign manufacturers who export devices to the country, are subject to the Medical Device Reporting (MDR) regulation. Also subject to MDR requirements are persons or entities that process a single use device for reuse purposes.
These requirements include the submission of three types of MDR reports:
- 30 day initial reports;
- 5 day reports; and
- Supplemental reports.
The guidance details the necessary information to be included in each type of report and the mandatory time frame for submissions.
The FDA believes that manufacturers have a responsibility to inform all persons to immediately forward adverse event information and submit the MDR reports accordingly.