Congress, FDA Commissioner Question Device Pre-Market Review Process

Full article reprinted from "The Gray Sheet" - June 22, 2009

House Energy and Commerce Health Subcommittee Chair Frank Pallone said legislation is needed to restrict the types of devices cleared through FDA's 510(k) process. Read more...

Congress, FDA Commissioner Question Device Pre-Market Review Process

Full article reprinted from "The Gray Sheet" - June 22, 2009

House Energy and Commerce Health Subcommittee Chair Frank Pallone said legislation is needed to restrict the types of devices cleared through FDA's 510(k) process.

"There is evidence of an approval system that's broken," the New Jersey Democrat said at a June 18 subcommittee hearing to examine the adequacy of current device regulations in protecting patients.

"I think there's a need for legislation here," Pallone told "The Gray Sheet."

"I don't think the issue is whether or not we should have a 510(k) process ... but whether it is overly used, and essentially abused," he said during the hearing.

William Maisel, a cardiologist at Beth Israel Deaconess Medical Center, agreed that too many devices are cleared through the less-stringent 510(k) review program. More than 90% of medical devices enter the market via 510(k) review; other low-risk products are exempt from pre-market notification, and only about 1% of devices go through the most-rigorous pre-market approval (PMA) process.

Maisel told the subcommittee that "more safeguards are needed."

Although FDA has "most of the tools that they need" to regulate the broad spectrum of medical products, "there needs to be better clarification of which type of 510(k) devices should have clinical data associated with them. I don't think it should be on a case-by-case basis," Maisel testified.

Rep. John Dingell, D-Mich., also suggested that FDA may have "too much discretion" to determine whether products going through 510(k) review have the same intended use or technological characteristics as existing devices.

 

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