Report Blames Speedy FDA Clearance for Medical Device Recalls

Alan Mozes, U.S. News: February 14, 2011

Most medical devices recently recalled by the U.S. Food and Drug Administration for posing life-threatening or serious safety risks were initially approved for use by that same agency through an expedited approval process, new research reveals.

The findings call out for an overhaul of the regulatory process, to keep unsafe products from reaching the market in the first place, said the study team, led by Diana M. Zuckerman of the National Research Center for Women & Families, based in Washington D.C.

About one-third of the recalled devices were related to cardiovascular concerns, although the speedy approval process is supposedly reserved for products posing only a low or moderate safety risk, the study authors noted.

Their report is published online Feb. 14 in advance of print publication June 14 in theĀ Archives of Internal Medicine.

“The standards used to determine whether a medical device is a high-risk or life-sustaining medical product prior to approval are clearly very different from the standards used to recall a medical device as life-threatening,” the authors noted in a journal news release. “Our findings reveal critical flaws in the current FDA device review system and its implementation that will require either Congressional action or major changes in regulatory policy.”

The FDA, however, has already taken steps to strengthen its approval process, according to an agency spokeswoman who noted these findings are not new. […]


Read the original article here.