FDA Medical Device Approval System Broken

At the subcommittee's hearing on the Medical Device Safety Act of 2009, Rep. Frank Pallone Jr. (D-NJ), chairman of the health subcommittee of the House Energy and Commerce Committee said that "there is evidence that the Food and Drug Administration (FDA) approval system for medical devices is 'broken' and a comprehensive review of the major issues and potential problems is needed" according to CQ HealthBeat. During the same hearing, Marcia Crosse, the Goverment Accountability Office's director of Healthcare, said "that the GAO has repeatedly pointed to shortcomings in the medical device approval process that continue today." Pallone called for the standards, procedures and rules for certain approving certain devices need to be adjusted to meet modern needs in getting the devices to those in need with confidence in their safety.