• E-mail
• Print
• RSS

President signs FDA Amendments Act

Device Regulation Alert: Safety, Compliance and Reimbursement News, October 1, 2007

On September 27, President Bush signed "The Food and Drug Administration Amendments Act," reauthorizing the Medical Device User Fee and Modernization Act (MDUFMA).

The FDA issued a press release praising the passage of the legislation and reauthorization of the MDUFMA. The FDA release credits the MDUFMA with getting safe and effective devices to the public faster. Click here to read The FDA statement.

In addition to reauthorizing the user fee program, the legislation also includes provisions concerning the regulation of medical devices such as a unique device identification system that would require inclusion of a unique identifier on device labels.

The legislation also reauthorizes the Prescription Drug User Fee program, the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. Addressing pediatric devices, the legislation includes provisions concerning pediatric device research and post-market surveillance of pediatric devices. Finally, the legislation addresses food safety.

The legislation, as passed by the House and Senate and presented to the White House can be found on theLibrary of Congress Web site. Search for bill number "H.R. 3580."

• E-mail to a Colleague
• Print
• RSS
• Archive