1 / 10

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

2 nd Annual CDRH/CBER Stakeholder Meeting November 18, 2004 Gaithersburg, 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

axel-stanley
Download Presentation

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

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. 2nd Annual CDRH/CBER Stakeholder MeetingNovember 18, 2004Gaithersburg, MD Modular PMA Updates Thinh Nguyen CDRH/ODE

  2. 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

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

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

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

  6. Modular Data FY 00 – FY 03

  7. 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

  8. 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 predictability • Disadvantage – Longer review time

  9. 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 time • Disadvantage – Less predictability

  10. Modular Performance Goal • Other Options? • Submit to MDUFMA Docket

More Related