A new FDA proposal is meant to streamline voluntary malfunction summary reporting for medical device companies.
The proposal – which is now under a comment period until Feb. 26, 2018 – would allow a medtech company to provide certain malfunction medical device reports (MDRs) in a summary format on a quarterly basis – instead of filing each individual MDR within 30 days.
The proposed Voluntary Malfunction Summary Reporting Program would not include device user facilities or importers of medical devices.
FDA further explained in its announcement:
“This announcement reflects goals for streamlining malfunction reporting outlined in the commitment letter agreed to by FDA and industry and submitted to Congress, as referenced in the Medical Device User Fee Amendments Act of 2017 (MDUFA IV Performance Goals and Procedures). These goals include permitting manufacturers of devices in certain product codes to report malfunctions on a quarterly basis and in a summary format.”
Under the proposed summary reporting program, FDA would still require individual reports within 30 days if a device is potentially involved in a reportable death or serious injury.
A previous pilot program at FDA found that summary reporting reduced the volume of reports by more than 87% while preserving information around the context of malfunction event. Bundling “like events” into a single summary report, according to FDA, would greatly reduce the number of reports manufacturers need to submit to FDA, streamline work at FDA, and would make malfunction event trends for a particular device more readily transparent to the public.
FDA’s proposal to streamline the voluntary malfunction summary reporting is encouraging news, said Lisa Olson – president 0f RCRI, a regulatory consulting company based outside Minneapolis.
“While frequent reporting helps transparency, it does create a lot of work for everyone,” Olson said. “The FDA is in a difficult spot balancing congressional requirements, good regulatory science and public education. The latest approach is an encouraging sign that the agency is thinking creatively to protect public health while minimizing reporting burdens.”
