Tuesday, February 21, 2012

New House Bill to Change Medical Device Approvals Process

(exerpts from Rottenstein web site)

Future Models Wouldn’t ‘Repeat Same Flaw’ under the Bill

On February 2, 2012, Bloomberg‘s Web site reported that House Democrat Edward Markey (MA) sponsored a bill that would prevent medical device manufacturers from claiming their new products are “substantially equivalent” to existing, approved problematic devices. Specifically, the bill came about not because of the DePuy hip recall but because of a 1999 recall of vaginal mesh manufactured by Boston Scientific. Despite the numerous injuries Boston Scientific’s mesh caused women, subsequent manufacturers still used it to help their newer meshes through the 510(k) process. As a result, many women were injured.

If passed into law, the bill would permit the FDA to deny 510(k) premarket approval if the manufacturer of the preexisting device(s) had recalled their product or if the FDA was in the process of deciding to remove it. Manufacturers would also have to demonstrate how their new devices differed from troubled ones, and importantly, they would have to report to Congress if any devices in their current products’ “device lineages” had been recalled.

When asked to comment on the bill, Representative Markey said, “If an automobile is recalled for a major safety problem, we wouldn’t allow future models to repeat this same flaw, and the same should be true for the medical devices used in our bodies.” “The bill ensures that devices do not mimic the mistakes made by other products.”

No comments:

Post a Comment