2nd Annual CDRH/CBER Stakeholder MeetingNovember 18, 2004Gaithersburg, MD

Modular PMA Updates

Thinh Nguyen

CDRH/ODE

Modular PMA Guidance

Revisions:Panel track supplements, i.e., those with pre-

clinical data, may be submitted as modular PMA

Modules may be submitted at the same time if acceptable to review division

Modular PMA Data FY 00 - FY 03Number of Modules Received

86

80

83

73

6668707274767880828486

Nu

mb

er

of

Mo

du

les

FY 00 FY 01 FY 02 FY 03

Fiscal Year

Modular PMA Data FY 00 - FY 03Avg. Review Time Per Cycle

130 123

104

127

0

20

40

60

80

100

120

140

Avg

. R

evie

w T

ime (

FD

A

Days)

FY 00 FY 01 FY 02 FY 03

Fiscal Year

Modular PMA Data FY 00 - FY 03Avg. # of Review Cycles

1.3 1.3 1.31.2

0

1

2

Avg

. R

evie

w C

ycle

FY 00 FY 01 FY 02 FY 03

Fiscal Year

Modular Data FY 00 – FY 03

91 92107

138

185

9195

122

180

258

90 91

115

135

196

114129 135

182

220

0

50

100

150

200

250

300

Nu

mb

er

of

FD

A D

ays

FY 00 FY 01 FY 02 FY 03

Percentile

50%

60%

70%

80%

90%

Modular Data FY 00 – FY 03

Number of modules are decreasing (per FDA guidance document)

Modules are more complex (e.g., pre-clinical vs. biocompatibility)

Wide variability in the number of review days Review time is unpredictable

Proposed Performance GoalOption #1 The following cycle goal will applied:

For FY 06, 70% of the modules received will have an action taken within 120 days for each review cycle

For FY 07, 80% of the modules received will have an action taken within 120 days for each review cycle

Advantage – More predictabilityDisadvantage – Longer review time

Proposed Performance GoalOption #2 The following cycle goal will applied:

For FY 06, 50% of the modules received will have an action taken within 90 days for each review cycle

For FY 07, 60% of the modules received will have an action taken within 90 days for each review cycle

Advantage – Shorter review timeDisadvantage – Less predictability

Modular Performance Goal

Other Options? Submit to MDUFMA Docket