The FDA announced it is taking steps to advance innovation and surveillance for medical devices through the implementation of three initiatives related to the recent user fee re-authorization, according to an Aug. 16 news release.
For its first initiative, the FDA has finalized the Voluntary Malfunction Summary Reporting Program, which allows medical device manufacturers to report device malfunctions in summary form on a quarterly basis—rather than on an individual basis—for certain product codes.
A piloted version of the program posed several benefits, according to the FDA, including more efficient review of malfunction issues that did not compromise the surveillance and public availability of post-market information regarding the devices.
The finalized program has three limitations:
- It does not apply to reportable death or serious injury events (which are still required to be sent to the FDA within 30 calendar days of the manufacturer becoming aware of those events).
- Devices under product codes in existence for less than two years are not eligible for the program.
- The FDA also may still require individual malfunction reports instead of summary reports for devices that are eligible for the program, such as when individual reports are necessary for specific devices or from a specific manufacturer in order to address a public health issue.
Secondly, the FDA is requesting public commentary on a proposed list of accessories to which general controls will provide assurance of safety and effectiveness. This effort is to fulfill another requirement of the FDA Reauthorization Act of 2017.
If the FDA classifies these accessories as class I, low-risk devices, it will “reduce the regulatory burden for those devices and help support the agency’s risk-based approach so that resources can be better focused on the products that pose the most risk to patients,” stated the agency.
Lastly, the FDA has issued a draft guidance called, Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices.
According to the agency, this guidance explains the denial process for Certificate to Foreign Government (CFG) request for medical devices exported from the U.S.
“This guidance applies only to CFGs for devices that are approved or cleared for marketing in the U.S. or are exempt from premarket submission requirements,” the FDA explained. “It is intended to provide clarity for those seeking these certificates, and the FDA will consider comments submitted about the draft guidance before determining a final approach.”