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Compliance In Focus
Posted by John Lehmann on Mon, Jun 4, 2012

Medical Device User Fee Act- Full Steam Ahead!

Act Moves ForwardThe votes are in! The FDA Reform Act (FDARA) was strongly supported by the House of Representatives in their recent vote. We’ve been following the progress of the act, as it’s a hot topic in our industry.

This act includes many titles, but the main one our industry is focused on is Title II: The Medical Device User Fee Act Reauthorization. According to a Fact Sheet online, the title hopes to speed the review of medical devices by making the following improvements:

  • FDA would have to report its total time for reviewing devices
  • Review process would include greater interaction between sponsors and the agency
  • An independent entity would review the device approval and clearance process
  • FDA would have to implement a corrective action plan to address deficiencies

Faster reviews while maintaining patient safety- sounds like a win-win! However, the fine print includes millions of dollars in user fees, around $595 million over the next five years, in order to support these initiatives. The FDA user fees will also create new FDA programs to help innovative products reach patients faster, and secure industry employment.

This bill’s passage through the house was also covered in a MassDevice article. In the story it’s noted that “medical device makers largely lined up in support of the agreement, in which the FDA agreed to a number of changes in device review protocol in efforts to improve decision times and make the process more transparent and predictable.”

We would love to hear your thoughts on FDARA. Were you surprised at the almost unanimous bipartisan House vote? Let us know what you think.

Photo Credit: andynash


Topics: The FDA Reform Act, The Medical Device User Fee Act Reauthorization, House of Representatives


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