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MDUFMA Update

MDUFMA Update. Blood Products Advisory Committee December 12, 2003. Mary Elizabeth Jacobs, Ph.D. Associate Director for Regulatory Affairs Office of Blood Research and Review Center for Biologics Evaluation and Research. MDUMA Update. Resources and Workload Review Performance FY 03

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MDUFMA Update

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  1. MDUFMA Update Blood Products Advisory Committee December 12, 2003 Mary Elizabeth Jacobs, Ph.D. Associate Director for Regulatory Affairs Office of Blood Research and Review Center for Biologics Evaluation and Research

  2. MDUMA Update • Resources and Workload • Review Performance FY 03 • MDUFMA Implementation • Stakeholder Meeting • FY 04 Plans

  3. CBER Resources • FTEs for Device Review • FY 02: • 56 FTEs total device “burn” • 47 FTEs in MDUFMA activities • FY 03: • 69 FTEs total device “burn” • 41 in OBRR • 59 FTEs in MDMFMA activities • 38 in OBRR • Expected 5% decrease in 04 budget

  4. CBER Workload FY 03: BLA/BLS • Submissions received 10/1/02 - 9/30/03

  5. CBER Workload FY 03: PMA • Submissions received 10/1/02 - 9/30/03 • PMAs (all modular) 3 • PMS (180 day) 2

  6. CBER Workload FY03: 510(k)s • Submissions received 10/1/02 - 9/30/03

  7. 510(k)s Received by CBER(does not include Transferred and Refused to Accept)

  8. CBER FY 03 MDUFMA Performance 10/1/02 – 9/30/03 ALL MDUFMA FY’05 GOALS MET in FY’03

  9. Time to Final Decision*510(k) Receipt Cohort from 10/1/02 – 9/30/03 *Includes SE/NSE but not WTH (n=4) **Times may increase with completion of pendings.

  10. CBER 510(k) Cycles(from receipt to final decision as of 9/30/03*) *Includes SE/NSE but not WTH (n=4) **Cycles may increase with completion of pendings.

  11. Workload FY 02 vs 03: 510(K)s • No. 510(k)’s received in FY 02 and 03 Type 02 03 • traditional 28 46 • abbreviated 7 7 • special 5 11 • total 40 64

  12. Average Review Times for 510(k)’s Received in 02 and 03 • Comparison of FY 02 and FY 03 is for submission cohorts at end of their respective fiscal years FDA Time to SE/NSE decision (days) Type 02 03 • Traditional 147 65 • Abbreviated 108 60 • Special 42 18 • Total 115 53

  13. Average No. Cycles for 510(k)’s Received in FY 02 and FY 03 • Comparison of FY 02 and FY 03 is for submission cohorts at end of their respective fiscal years Average Cycles to SE/NSE Decision Type 0203 • Traditional 1.75 1.32 • Abbreviated 1.67 1.33 • Special 1.67 1.00 • Total 1.71 1.24

  14. What improvements led to better performance in FY 03? • Better management • Input from a professional consultant • Better definition of roles, mentoring • Focus on problem solving in-cycle • Emphasize problem solving, not just problem finding • Complete review earlier in cycle, then problem-solve • Supervisor and Reviewer training • Least Burdensome • 510(k) paradigm • Reinforce training at Division meetings

  15. Better Performance, (cont.) • Better document handling • New courier service • Barcoded delivery system • Now extended to INDs • Improved SOP for document handling • Harmonization with CDRH • Best practices workshop

  16. MDUFMA Implementation (since June BPAC) • Guidance • PMA letters • Modular Review • Pediatric Devices • List of Accredited Persons for Third Party Inspections

  17. MDUFMA Stakeholders Meeting December 3, 2003 • Opportunity to present views • Gaithersburg Hilton • Pre-registration required • Notice on CDRH website at: www.cdrh.fda.gov

  18. MDUFMA Priorities: FY ‘04 • ‘03 concentrated on timeliness, problem solving, met all 05 goals • ‘04 maintain timeliness, problem solving approach • ‘04 training in MDUFMA guidances, implementation, e.g., bundling, consistency of review, enhanced management oversight

  19. MDUFMA Priorities: FY 04 • Consistency of review • Strict adherence to review pathways • Expanded use of checklists • Clear expectation for management oversight • Building on detailed SOP for process • Detailed schedule to all reviewers • Initiate earlier review of labeling

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