Regulatory/Compliance

Dr. Jeffrey Shuren, head of the Food & Drug Administration’s medical device oversight arm, told a Massachusetts audience that results from the agency’s internal, soup-to-nuts review of its 510(k) clearance program are due out in a few weeks.

At the second in a series of "town hall" meetings in Woburn, Mass., the Center for Devices & Radiological Health’s leader said the federal watchdog would seek public comment on the report before making any changes to the program.

Shuren told MassDevice that the agency still hasn’t decided exactly what changes are in store for the 510(k) process.

As part of its ongoing attempt to remove bureaucratic impediments from the development of medical devices, the Food & Drug Administration is planning a public workshop to address innovation in the medical device industry June 24 in Washington.

The Food & Drug Administration is proposing to expand the amount of information it reveals about its approvals process for medical devices and drugs, including revealing applications for investigational device exemptions and when it denies applications.

The 21 proposed changes, released May 19, are already drawing fire from industry. AdvaMed, the national lobby for the medical devices industry, said the proposed changes would weaken intellectual property protections and stifle innovation.

Dr. Jeffrey Shuren, director of the Food & Drug Administration’s medical device oversight arm, will present the Center for Devices and Radiological Health’s priorities for the upcoming fiscal year, which include facilitating innovation and increasing transparency.

The FDA branch launched a transparency website in April to share information about its decisions on medical devices and radiation-emitting products. The CDRH is also hoping to address how the FDA engages with the medical device industry.