The Senate should include the legislation in any 2012 reauthorization of the medical-device user-fee law, Sen. Chuck Grassley (R-Iowa), one of the bill’s co-sponsors, said in a written statement.
FDA officials and many Democrats have repeatedly cited injuries inflicted by some medical devices approved under the 510(k) process to push back against industry arguments that the costly FDA approval process is stifling innovation through burdensome and inconsistent approval requirements.
“Unsafe medical devices pose severe dangers to patients and impede approval of new, safe devices—causing significant costs to our economy as well as health,” Sen. Richard Blumenthal (D-Conn.), another bill co-sponsor, said in a news release.
In addition, the bill’s co-sponsors, including Sen. Herb Kohl (D-Wis.), chairman of the Senate Special Committee on Aging, have sent investigative letters to five companies that recalled faulty medical devices to request detailed information about the companies’ post-market surveillance and recall practices. One letter was sent to Johnson & Johnson, in reference to its DePuy metal-on-metal hip implant, which was the subject of an April 13 worldwide recall.
Wanda Moebius, vice president of policy communications for the Advanced Medical Technology Association, said her organization has not yet seen the bill but “study after study has shown that the 510(k) clearance process is remarkably safe.”
In addition, Moebius said in an e-mail to Modern Healthcare, the FDA already has extensive post-market authority regarding medical technology.