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 FDA’s Center for Devices and Radiological Health wants to to facilitate device innovation through the loosening of regulatory practices, establishing a Council on Medical Device Innovation to identify the unmet public health needs and obstructions to medical device development where action by the federal government can have an effect. During the workshop, members of the council will discuss the tension between regulation and innovation in the medical device business.
The FDA has recognized the public health benefits of medical devices but also noted in its announcement of the meeting that “unnecessary barriers to market may exist either due to market failures or regulatory inefficiencies” and that those barriers may be "out of proportion to what is warranted based on the public health needs."
Participants in the workshop must register on the FDA’s website by June 9.
MassDevice will hold a webcast detailing decision times, third-party review details and more on the Food & Drug Administration’s 2009 510(k) clearances.