U.S. regulators should make sure high-risk medical devices undergo the agency's toughest review process before they are allowed on the market, a congressional watchdog report said on Thursday.

A Democratic lawmaker said he would hold hearings on the FDA's device review process and, if needed, develop legislation to protect patients.” GAO’s investigation confirms my concerns that the approval process for medical devices is woefully inadequate. For years, Congress has required high-risk medical devices to undergo stringent pre-market review, but GAO's findings show that is simply not happening in every case," said New Jersey Rep. Frank Pallone, who chairs the health subcommittee of the House of Representatives Energy and Commerce Committee.

 


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