CBER MDUFMA Activity

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