Premarket Review Performance Goals

1
Premarket Review Performance Goals

• Patricia B. Shrader
• BD
• November 18, 2004

2
What Do FDAs Numbers Show

• Staffing
• PMA Performance Goals
• 510(k) Performance Goals

3
Staffing

• 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)

• 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
• Of 14 expedited PMAs, 4 decisions (100 meet 2005
  goal of 70 within 300 FDA days) and 29 of
  receipt cohort meeting goal
• 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)

• Of 3 original PMAs and PT supplements, 2
  decisions made (100 of decisions made within
  goal) 67 of cohort meets goal.
• Of 3 180 day supplements, 100 of decisions and
  100 of cohort meets goal.
• 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

• 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.
• 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 Companys Numbers
Show?

• 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.
• 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

• First cycle has lengthened, making it difficult
  to complete reviews in 90 calendar days.
• Simple submissions have increased from 60 to 90
  days.
• First round of questions now at 75 rather than 60
  days.

9
Future Needs

• 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
• Focus on lengthy application reviews (510(k) and
  PMA)
• Problem analysis and solutions implemented
• Focus on technology innovation and preparing for
  the future.