Most medical devices recently recalled by the FDA 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, says the study team, led by Diana M. Zuckerman of the National Research Center for Women & Families, based in Washington DC.

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, 2011, in advance of print publication June 14 in the 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 note 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.

Medical devices are not subject to the same approval procedures as prescription medications, the study authors noted. A 1976 amendment to the Food, Drug, and Cosmetics Act allowed for two types of medical device review processes: one that grants approval after stringent pre-market testing; the other providing "clearance" to market a new device if it is "substantially equivalent" in structure and usage to devices on the market pre-1976.

The latter, much-simplified process, called the "501(k) provision," was intended to relieve manufacturers from undue regulatory burdens that might discourage innovation.

The result: Today the 501(k) process is by far the more common method of clearance for new devices, with only 1% of new medical device reviews subject to the more rigorous pre-market testing standard, the researchers found.

Eighty of the 113 medical devices recalled by the FDA between 2005 and 2009 received 510(k) clearance, while another eight were exempt from all regulatory review procedures, the study found.

Moreover, 12% of the high-risk recalled devices that got 510(k) clearance should have been subject to rigorous approval review because they were marketed for risky or life-sustaining purposes, the authors said.


[Source: Bloomberg Business Week]