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FDA Issues New PMA Guidance as a Part of MDUFA III Agreement

Thursday, October 18, 2012  
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While FDA began collecting updated user fees for PMAs earlier this month, new guidance detailing PMA submission and approval was issued this week. The changes in guidance are designed to speed up the review process and meet goals set by the agency. By 2017, FDA hopes to be meeting performance goals 90% - 95% of the time.

"The additional funds obtained from user fees will enable FDA, with the cooperation of industry, to improve the device review process to meet certain performance goals and implement improvements for the medical device review process," the agency wrote.

Some changes include:

  • Pre-application reviews
  • Shared outcome goals
  • Formulation of "Missed MDUFA Decision" notices

MDMA is following the implementation of MDUFA III very closely as well as working with Members of Congress as they address sequestration and appropriations for the FDA.

To read the full guidance document, please click here.