On February 2, 2012, Bloomberg Businessweek published an article regarding a recent bill presented by Democratic congressmen that proposes allowing the U.S. Food and Drug Administration (F.D.A.) to block a medical device if it is based on a past product that has been recalled or that has shown a safety issue. The bill would end a technicality that allows for the approval of a medical device based on a previously recalled product through the 510(k) process. The 510(k) process allows for the approval of a medical device if it is “substantially similar” to a product that is already on the market.
Last year, the F.D.A. issued an alert regarding vaginal implants that were causing pain and injury in a number of patients. Many of these vaginal implants were previously approved through the 510(k) process, based on a “substantial similarity” to a Boston Scientific Corp. mesh. The aforementioned mesh was recalled due to safety concerns in 1999.
The bill presented by Democratic lawmakers not only proposes blocking the approval of medical devices if based on recalled products, but would also require that the F.D.A. review previously approved products to determine the devices that these were based on. Reports on the “device lineage” of a product would then be presented to Congress within three years.
Republican lawmakers also recently presented a bill regarding the F.D.A.’s approval process of medical devices. The bill, spearheaded by Senators John McCain and Bob Casey, proposes streamline the current approval process and easing the agency’s “burdensome review” of new medical devices.
See the full Bloomberg Businessweek article at: