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Compliance In Focus
Posted by Brandy Smith on Fri, Oct 19, 2012

NEW!! FDA Guidance for Review/Approval Time-Lines

Stemming from the much anticipated Medical Device User Fee & Modernization Act (MDUFMA), FDAC  Users jlehmann Pictures New Staff Images 062011 Imarcfinishemail New FDA guidance for review approval timelines issued a new guidance regarding Premarket Approval Applications (PMAs) review and approval timelines. As the guidance plainly states in the introduction “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.”

As part of the improvements to the medical device review process, the new user fees set decision goals as follows:

  • 180 Days: Original PMAs and Panel-track Supplements without panel
  • 320 Days: Original PMAs and Panel-track Supplements with panel
  • 90 Days: Real-time Supplements
  • 180 Days: 180-day Supplements
  • A shared goal for total time from application submission to decision
  • "Missed MDUFA Decision" notices for companies whose reviews have missed goals by 20 days

FDA also lays out in the guidance specifics on when the review “time clock” starts and stops with each step regarding FDA’s actions:

  • Approval Order
  • Approvable Letter
  • Major Deficiency Letter
  • Not Approvable Letter
  • Denial Order
  • Acknowledgement of Voluntary Withdrawal

As with any newly established goals, these are ones FDA hopes will be easier to obtain as processes improve. In fact, the agency hopes to reach the timeline goals 90%-95% of the time- consistently- within the next five years.

Hopes are that this guidance will help all players involved, specifically Center for Devices & Radiological Health (CDRH) and the medical device industry, with satisfaction in review times and goals. After all, with a drastic increase in User Fees for PMAs, hopefully industry gets what it’s paying for.

Have you read the new guidance? Do you think this is a positive outcome from the new MDUFMA agreements? Share your thoughts below.

Photo Credit: Moonrhino

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Topics: FDA Guidance, Review/Approval Time-Lines, Medical Device User Fee & Modernization Act, FDA


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