FDA Confirms Interim Requirement to Report Device Malfunctions Until it Adopts Alternative Reporting Criteria Through Rulemaking

By Jennifer B. Davis –

Three and a half years ago, Congress directed FDA to identify lower risk devices for reporting malfunction MDRs on a quarterly basis in summary form.  FDA still has not done so. 

Specifically, the Food and Drug Administration Amendments Act of 2007 (“FDAAA”), Title II, section 227, amended section 519(a) of the FDC Act.  The amendment directed FDA to identify in a Federal Register notice, or through letters to manufacturers, those Class I and Class II devices (if not permanently implantable, life supporting, or life sustaining) that the agency determined should remain subject to the Part 803 Medical Device Reporting requirements, and to establish new, less burdensome criteria for reporting malfunctions for such devices in summary form on a quarterly basis.  (The reporting requirements for Class III devices, and for Class II devices that are permanently implantable, life supporting, or life sustaining were not affected by FDAAA.  We also note that some devices could, if FDA so determines, be altogether exempt from malfunction reporting.)

Since the enactment of FDAAA, FDA has taken no action to implement this amendment,  prompting understandable industry confusion as to what the current malfunction reporting requirements really are – until now, that is.  Last week, FDA published a Federal Register notice clarifying that manufacturers and importers of class I and class II not permanently implantable, life supporting, or life sustaining devices “must continue to report in full compliance with part 803, pending further FDA notice . . . as to specific device types subject to part 803, and the establishment of [alternative reporting] criteria.”  Notwithstanding congressional intent that the reporting burden be reduced, the agency maintains “it is necessary to subject all such devices to part 803 in the interim, in order to protect the public health by ensuring that there is no gap in malfunction reporting for any device.”  Given the uncertainties about whether and how FDA actually reviews and uses malfunction medical device reports once they are submitted, this rationale seems questionable.  The notice does not say when FDA plans to propose regulations implementing the amendment.  The wait continues . . . .