FDA BRIEF: Week of August 29, 2016
NEW LOGO
MDUFA IV REAUTHORIZATON MEETING & FDA COMMITMENTS
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