User fee reauthorization bills seek FDA reform: definition of custom devices to be clarified

Congress is currently taking action to reauthorize the user fee programs for devices and prescription drugs, which are currently set to expire on 30 September 2012, and to establish user fee programs for generic drugs and biosimilars. On 24 May 2012, the Senate passed the Food and Drug Administration Safety and Innovation Act. A similar bill, the Food and Drug Administration Reform Act was passed by the House on 30 May. The two bills are now in conference committee. Congressional leadership would like to see the combined bill passed before the 4 July recess. In addition to reauthorizing the user fee programs, these bills include a range of other provisions seeking to reform the U.S. Food and Drug Administration's (FDA) regulation of medical devices, including a provision that seeks to clarify the definition of “custom devices.”

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