The U.S. 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. 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 Medical Device Reporting (MDR) regulation, according to Regulatory Focus (RAPS). 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.
"FDA believes that manufacturers have a responsibility to inform all employees, including marketing, sales, engineering, manufacturing, regulatory, legal, installation, and service personnel, to immediately forward adverse event information to the appropriate person appointed by those entities to submit MDR reports," the agency states in the final guidance.
According to FDA, a medical device may be considered to have "caused or contributed" to a death or serious injury, or to have played as a factor in these adverse events, as a result of either: device failure; malfunction; improper or inadequate design; manufacture; labeling; or user error. Any of these reasons may constitute an MDR reportable event, for which manufacturers should submit an MDR report using appropriate FDA forms.
FDA enjoins manufacturers to investigate all complaints of adverse events, but points out certain situations when an MDR report need not be submitted.
For instance, a manufacturer can opt not to file a report when it has information by persons qualified to make a medical judgment (e.g., physicians, nurses, risk managers, biomedical engineers) that a device did not cause or contribute to a death or serious injury, or that a malfunction would not be likely to cause or contribute to a death or serious injury, if it were to recur. The manufacturer, however, should document said information in its MDR event files.
FDA requires manufacturers to establish and maintain – for two years from the date of the event or a period equivalent to the expected life of the device, whichever is greater – complete MDR files in either written or electronic form, and should identify them prominently as “MDR Files” so they can be located easily.
Also, companies should develop, maintain, and implement written MDR procedures, which must describe how the manufacturer conducts its own investigations of events that may be reportable. FDA says these internal investigations should involve "good faith effort" on the part of the manufacturer to obtain necessary information about the event.
According to FDA, it reserves the right to release information in MDR reports for public disclosure in response to a Freedom of Information Act request. However, the agency said it will delete any information pertaining to trade secrets, financial information, and personal health information (including serial numbers of implanted devices).
FDA also provides examples of specific issues and situations that manufacturers may encounter when dealing with potential MDR reportable events, and when filling in specific items in FDA forms to be submitted.
The release of the 52-page, Q&A-format final guidance comes a month after some lawmakers questioned FDA for keeping retrospective summary reports of thousands of cases of device-related patient injuries, years after they occurred. In response, the regulator says requiring excessive paperwork would "clog" the reporting system and strain resources.
FDA is working to improve its post-market surveillance activities through other means, however, and has scheduled a workshop to seek advice on how to facilitate the reporting of device-related death or serious injury events by U.S. hospitals.