The Food & Drug Administration’s Center for Devices and Radiological Health will release its proposed changes for the 510(k) regulatory pathway for medical devices, President Barack Obama revealed today.
In an opinion piece for The Wall Street Journal, on how to make U.S.’s regulatory systems more efficient, Obama included one sentence regarding the the process for which 2,654 new medical devices were cleared for market last year.
"Tomorrow the FDA will lay out a new effort to improve the process for approving medical devices, to keep patients safer while getting innovative and life-saving products to market faster,"Mr. Obama wrote.
The Advanced Medical Technology Assn., which provided detailed comments on the recommendations the CDRH released for an overhaul of the 510(k) system last August, is hopeful that the FDA will be responsive to industry concerns. AdvaMed was supportive of many of the recommendations put forth in August, but a lot depends on how the guidance is implemented.
"We’re hopeful. We have the sense that the FDA has been sensitized and is responsive to industry concerns and issues over competition," AdvaMed senior executive vice president David Nexon told MassDevice. “The FDA’s own report showed a real deterioration in their performance, so we’re cautiously optimistic, but we’re concerned over sweeping recommendations that could have a negative effect on the industry," he said.
The reception of the 510(k) recommendations has been mixed. Outgoing Medtronic CEO Bill Hawkins last week predicted the forthcoming changes "will be neutral to slightly negativee" for companies looking to get innovative new devices to market. Former 510(k) chief Heather Rosecrans said in November she is skeptical of the CDRH’s proposal to create a new Class IIb designation, which would require clinical data submissions. Meanwhile, Minnesota Sens. Amy Klobuchar (D) and Al Franken (D) along with Rep. Erik Paulsen (R), have championed the medical device industry with speeches and letters to the FDA about upcoming changes to the 510(k) program over the past few months.
FDA chief Dr. Margaret Hamburg has sought to quell concerns over the overhaul.
"We are really undertaking a serious, thoughtful process of review of all the comments as we shape the process,” Hamburg said in an October speech at the annual AdvaMed MedTech conference in Washington, D.C. “As we go forward, there will be still be opportunities for comment, feedback, discussion and shaping.”
The FDA plans to release its proposal on the 510(k) changes tomorrow afternoon at 1:00 p.m.