The Food & Drug Administration wants the public’s help in figuring out whether its premarket approval process for medical devices is strict enough.
In May, the FDA set out to be more transparent with its approval process. Among possible changes, the agency is considering the public disclosure of companies’ investigational device exemption filings, a proposed change to the PMA process that drew fire from industry groups including AdvaMed, which cited intellectual property issues. The industry council has been lobbying the FDA to balance innovation and public safety to boost the device industry’s economic performance.
The agency specifically wants comment on whether its proposals will be practical and enhance the process. It’s also looking for input on the accuracy of its estimates about the burdens the protocol places on device makers and ways to reduce that burden, including how to make the data collection process more efficient.
In January, the federal watchdog’s Center for Devices and Radiological Health announced substantial changes to the 510(k) and PMA approval processes and a possible re-organization of the entire agency. The FDA planned to make many the changes, outlined on its website, by September. The proposed adjustments include implementing a “total product life cycle approach,” enhancing communication and transparency, strengthening its workforce and finding new ways to address unmet public needs. The FDA held a public meeting in February covering its review and clearance of medical devices sold and marketed in the U.S. CDRH director Dr. Jeffrey Shuren will present his agency’s priorities for the upcoming fiscal year at a town hall meeting in Woburn, Mass., June 22.