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CBER MDUFMA Activity

CBER MDUFMA Activity. MDUFMA Stakeholder Meeting November 18, 2004. Leonard Wilson Review Management Center for Biologics Evaluation and Research. MDUFMA Implementation. Harmonization with CDRH Continues Participation on all MDUFMA Committees

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CBER MDUFMA Activity

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  1. CBER MDUFMA Activity MDUFMA Stakeholder Meeting November 18, 2004 Leonard Wilson Review Management Center for Biologics Evaluation and Research

  2. MDUFMA Implementation • Harmonization with CDRH Continues • Participation on all MDUFMA Committees • MDUFMA guidances issued as joint documents by CDRH and CBER • Harmonization of review processes and procedures • e.g. use of CDRH “blue book” memos as interim general reviewer guidance pending development of appropriate CBER SOP’s • Device Review Subcommittee of RMCC • Management initiatives in OBRR

  3. CBER DEVICE FTEs

  4. Preliminary FY03 510k Performance 10% of cohort awaiting final decision as of 10/31/04 Performance may decrease with completion of pending submissions.

  5. Preliminary FY04 510k Performance 11% of cohort awaiting final decision as of 10/31/04 Performance may decrease with completion of pending submissions.

  6. Preliminary FY03 PMA Performance 33% of cohort awaiting final decision as of 10/31/04 Performance may decrease with completion of pending submissions.

  7. Preliminary FY04 PMA Performance 100% of cohort awaiting final decision as of 10/31/04 Performance may decrease with completion of pending submissions.

  8. FY03 BLA Performance

  9. Preliminary FY04 BLA Performance

  10. What improvements led to better performance ? • Better management • Focus on problem solving in-cycle • Supervisor and Reviewer training • Document handling further improves (e-submissions too!) • CBER/CDRH 3rd annual Best Practices workshop

  11. MDUFMA FY 05 • Apply a Quality Systems approach to the Review Process • CBER 510(k)s increasing • Systematic management of time frames (cycle strategy) • Mid cycle meeting • Increased electronic submissions

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