The Medical Device User Fee Agreement (MDUFA) IV that was authorized recently included some initiatives of interest to the medical technology industry. Three of them were fleshed out today by FDA Commissioner Scott Gottlieb, MD. They include a new process for reporting device malfunctions, a proposed list of device accessories suitable for re-classification to the lowest-risk Class I category and draft guidance on the issuance of Certificates to Foreign Government requested by firms exporting FDA-regulated medical devices from the United States.
FDA announced that it has posted a Federal Register notice and opened a public docket requesting comments on a proposed list of accessories for which, it says, “general controls will provide a reasonable assurance of safety and effectiveness and which the FDA may classify as Class I, low-risk devices." This initiative 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, said the agency. “We are seeking public comment that will inform our thinking as we finalize this list,” added Gottlieb.
FDA also announced that it has finalized a program for manufacturer reporting of certain device malfunction medical device reports in summary form. The Voluntary Malfunction Summary Reporting Program allows manufacturers to report certain device malfunctions in summary form on a quarterly basis, rather than on an individual basis, for certain product codes. A pilot program conducted by FDA reportedly identified several benefits, including a more efficient review and understanding of malfunction issues. Also, because summary reports bundle similar malfunction events for a device, the identification of related adverse events and trends was improved, according to the agency. Safeguards have been included to ensure effective surveillance is not compromised and that public availability of post-market information remains readily available. The program does not apply to reportable death or serious injury events, which are still required to be sent to FDA within 30 calendar days of the manufacturer becoming aware of those events. There are other caveats, as well, including the ineligibility of devices that fall under product codes in existence for less than two years.
The program “will allow us to more efficiently detect potential safety issues and free up resources to better focus on addressing the highest risks, such as deaths and serious injuries, associated with medical devices,” said Gottlieb.
Finally, FDA issued draft guidance today titled, “Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices,” which explains the denial process for Certificate to Foreign Government (CFG) requests for medical devices exported from the United States. This guidance clarifies the reasons FDA may deny a request for a CFG, and describes the information that FDA will provide to a firm whose request for a CFG for a device is denied as well as the process for requesting a review of that decision. 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, said FDA in a news release.
Gottlieb characterized these three initiatives as steps FDA is taking to “advance innovation and surveillance for medical devices.”
They are part of the MDUFA agreement for 2019, which saw a slight uptick in fees from 2018. “The standard fee for a 510(k) premarket notification submission increased by only a couple hundred dollars, from $10,566 in 2018 to $10,953 in 2019,” reported Regulatory Focus, the media outlet for the Regulatory Affairs Professionals Society (RAPS). Both figures are more than double what they were in 2017, it added, when the fee was $4,690.