WASHINGTON — A key senator in the medical-device-reform debate said Congress probably will expand the limited trial of third-party approval rather than OK broader changes.
Sen. Paul Wellstone, D-Minn., a member of the Senate Labor and Human Resources Committee, said consumer groups and traditional opponents of third-party review — such as Sen. Edward Kennedy, D-Mass. — would need to sign off on the changes for them to make it through the Senate.
Committee Chairman James Jeffords, R-Vt., may want broader third-party review, but ``I don't think we'll go as far as [he] wants to go,'' Wellstone told the annual meeting of the Washington-based Medical Device Manufacturers Association, held May 16.
``I'll be very honest with you today and tell you the way to get something passed is to have balance and get consumers behind us,'' Wellstone said.
Third-party review would allows other organizations, such as private labs or universities, to approve medical devices, instead of the Food and Drug Administration.
FDA thinks the current pilot should be expanded, but is not in favor of third-party review of high-risk devices or those requiring clinical data, said R. Bruce Burlington, director of the agency's Center for Devices and Radiological Health.
Third parties also should not be able to give final approval, Burlington said.