Hogan Lovells Publications | Medical Device Alert | 07 December 2016
U.S. Senate passes 21st Century Cures Act, clearing numerous device-related provisions for the president’s signature
The U.S. Senate has just passed the 21st Century Cures Act, in line with the House of Representatives’ passage of the bill last week. This represents a culmination of efforts, dating back several years, to enact legislation to streamline how FDA reviews and approves drugs and medical devices. The bill incorporates several provisions that, once signed into law, would impact FDA’s premarket review and regulation of medical devices.
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