By Stewart Eisenhart, Emergo Group
Center for Devices and Radiological Health (CDRH)
FDA 510(k) changes drop tomorrow
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.
FDA device branch: Complaints surge, disputes cut in half
The Food & Drug Administration’s Center for Devices and Radiological Health saw 29 percent increase in complaints last year, logging a record high of 171 in 2010.
The surge in complaints is less dramatic than the 45 percent increase the agency saw from 2009 to 2010, but the number of contacts, comprised of complaints, disputes and inquiries the agency fielded rose from 250 to 414, up 66 percent.
MassDevice On Call: FDA science chair says agency not risk-averse
CDRH offers webinar on internal review
The Food & Drug Administration’s Center for Devices and Radiological Health will host a live webinar covering the agency’s recent internal review of the 510(k) program and the addition of a new Science Council designed to assist in FDA’s medical device decision-making.
The federal watchdog agency made a report on the CDRH’s review available August 4, requesting public comment on the proposed changes.