FDA BRIEF: Week of August 29, 2016

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MDUFA IV REAUTHORIZATON MEETING & FDA COMMITMENTS

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Industry attendees: MITA, AdvaMed,  ACLA, MDMA

FDA Commitments:

  • Improve consistency, predictability through enhanced supervisory oversight, audits
  • Establish  dedicated premarket Quality Management team
  • Improve quality and consistency of Additional Information and Major Deficiency letters
  • Reduce average total time to decision: 108 days (510(k)s), 290 days (PMAs) FY2022
  • Improve CLIA waiver process, offer CLIA Waiver vendor days, timelines
  • Implement IT improvements
  • Participate in independent assessment of CDRH review process
  • Implement more effective recruiting and hiring strategy
  • Improve employee retention
  • Implement complete time reporting by the end of MDUFA IV
  • Seek authority to eliminate the fifth-year fee offset
  • Improve Pre-Submission process and written feedback
  • Ramp up performance goal for 70% of De Novo within 150 days in FY2022
  • Issue MDUFA decision within 60 days of Advisory Committee recommendation for PMA
  • PMA decision  within 60 days of the sponsor’s response to the Approvable letter
  • Strengthen  Third Party Premarket Review program
  • Improve consistency in review of software as device, other Digitial Health activities
  • Develop expertise on patient engagement, PPI, PRO
  • Establish value of real world evidence to accelerate patient access
  • Etablish conformity assessment program for accredited testing laboratories
  • Enhance IT infrastructure
  • Treat LDTs no less favorably than other devices

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