FDA Says Malfunction Reports Needed for All Medical Devices Until Further Notice
The Food and Drug Administration has issued a notice to clarify that device manufacturers and importers of all devices, including class I and those class II devices that are not permanently implantable, life supporting, or life sustaining, must continue to submit malfunction reports in full compliance with FDA's Medical Device Reporting (MDR) requirements, pending future notice by FDA.
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Comments may be submitted on this notice and are due May 9, 2011.
MDR Requires Mfrs, Importers to Report Device Malfunctions Within Timeframes
The MDR requirements codified under 21 CFR Part 803 mandate that incidents in which a medical device may have caused or contributed to a death or serious injury be reported to FDA and others. For example, importers must submit malfunction reports of adverse events to FDA no later than 30 calendar days after becoming aware of a reportable event; manufacturers must submit reports to FDA no later than 30 calendar days after becoming aware of a reportable event or 5 days after becoming aware of an event that requires remedial action; importers must submit reports of device-related malfunctions to the manufacturer; etc.
However, FDAAA Lightened This Reporting for Certain Devices
The Food and Drug Administration Amendments Act of 2007 (FDAAA, (Public Law 110-85), amended the malfunction reporting requirements under 21 CFR Part 803 for class I devices and for those class II devices that are not permanently implantable, life supporting, or life sustaining.
Under the amended requirements, unless FDA publishes a notice in the Federal Register or sends a letter to the manufacturer or importer stating that a particular class I or class II device described above should be subject to the MDR reporting requirements under 21 CFR Part 803, then malfunction reports for such devices are to be submitted in accordance with other criteria which will be established by FDA.
(FDA explains that the FDAAA did not alter the malfunction reporting requirements for class III devices and those class II devices that are permanently implantable, life supporting, or life sustaining. Therefore, manufacturers and importers of these devices must continue to submit malfunction reports in accordance with the MDR requirements under 21 CFR Part 803. In addition, FDA notes that the FDAAA made no change to the obligation for an importer to submit malfunction reports to the manufacturer in accordance with 21 CFR Part 803 for devices that it imports into the U.S.)
FDA to List Devices Subject to MDR Reporting, Issue Rule on FDAAA Reporting
FDA intends to provide notice in the Federal Register that lists the types of devices that should be subject to the MDR reporting requirements in order to protect the public health. In addition, FDA intends to issue a rulemaking to establish the malfunction reporting criteria for the class I and class II devices which the FDAAA made subject to amended reporting requirements (e.g, reports in summary form and on a quarterly basis).
Until Then, MDR Reporting Needed for All Classes of Devices
To the extent there is confusion as to current malfunction reporting requirements, FDA is publishing this notice to clarify that in the interim, pending further notice by FDA as described above, all device manufacturers and importers of class I and those class II devices that are not permanently implantable, life supporting, or life sustaining, must (along with those Class III and II devices whose reporting was never eased) continue to report in full compliance with the MDR requirements under 21 CFR Part 803.
(Medical devices are classified into classes I, II, and III, with regulatory control increasing from class I to class III.)
FDA background information on MDR available here and here.
FDA contact - Victoria Schmid (301) 796-6108
(D/N FDA-2011-N-0097, FR Pub 03/08/11)