1. Premarket Review Performance Goals Patricia B. Shrader BD November 18, 2004

2. What Do FDA’s Numbers Show l Staffing l PMA Performance Goals l 510(k) Performance Goals

3. Staffing l CDRH Staff Increases ’02-’04  ODE and OIVD +15% (OIVD includes compliance activities)  OC +7%  OSB +13%  OSEL +15%  CBER +43%

4. PMA Performance (CDRH ’04 receipt cohort) l Of 41 original PMAs and PT supplements, 11 decisions meet 2006 goal of 80% decisions within 320 FDA days and 27% of receipt cohort meeting goal l Of 14 expedited PMAs, 4 decisions (100% meet 2005 goal of 70% within 300 FDA days) and 29% of receipt cohort meeting goal l Of 104 180 day supplements, 63% of decisions meet ’05 goal of 80% of decisions within 180 FDA days, 60% of cohort meet goal

5. PMA Performance (CBER ’03 receipt cohort) l Of 3 original PMAs and PT supplements, 2 decisions made (100% of decisions made within goal); 67% of cohort meets goal. l Of 3 180 day supplements, 100% of decisions and 100% of cohort meets goal. l BLAs: No originals. Of 3 efficacy supplements, 100% of decisions and 100% of cohort meets goal (action within 300 calendar days). Of 75 mfg. Supplements, 99% of decisions and 99% of cohort meets goal (action within 120 calendar days).

6. 510(k) Performance l CDRH: Of 3492 in MDUFMA receipt cohort, 2470 SE and NSE decisions; 89% meet ’05 goal of 75 of SE/NSE decisions within 90 FDA days; 63% of cohort meeting goal to date. l CBER: Of 60 in MDUFMA receipt cohort, 53 decisions (100% within goal) and 88% of cohort within goal.

7. The Big Question: What Do My Company’s Numbers Show? l For Medical Devices, in ’04, 2 traditional, 2 special 510(k)s and one STED submitted.  Traditional 510(k) review times 58 days and 117 days. Special 510(k) review times 24 days and 2 days. STED pending. l For Diagnostics, in ’04, 14 510(k) submitted, 13 traditional (12 CDRH, 1 CBER), 1 special.  Ten traditional 510(k)s cleared in less than 90 days (26-71 days), 1 special cleared in 21 days.  Three 510(k)s took 148, 173, and 248 days.

8. Anecdotal Data from Other Diagnostic Companies l First cycle has lengthened, making it difficult to complete reviews in 90 calendar days. l Simple submissions have increased from 60 to 90 days. l First round of questions now at 75 rather than 60 days.

9. Future Needs l Good Data!  Timing: GAO report incomplete because FDA had data on 11 of 20 established performance goals.  How fees are actually used (review v. surveillance activities)  Resources needed to review each type of application l Focus on lengthy application reviews (510(k) and PMA)  Problem analysis and solutions implemented l Focus on technology innovation and preparing for the future.