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Understanding the Pre-IDE Program: FDA Perspective

Understanding the Pre-IDE Program: FDA Perspective. CAPT Stephen P. Rhodes, USPHS Director, IDE and HDE Programs Office of Device Evaluation AdvaMed AudioConference October 17, 2007. Collaboration with regulated industry are integral to our mission.

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Understanding the Pre-IDE Program: FDA Perspective

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  1. Understanding the Pre-IDE Program: FDA Perspective CAPT Stephen P. Rhodes, USPHS Director, IDE and HDE Programs Office of Device Evaluation AdvaMed AudioConference October 17, 2007

  2. Collaboration with regulated industry are integral to our mission • Committed to communicating and interacting with our stakeholders • ODE/OIVD have 400+ meetings/year • Average 80 meetings per division: 2 meetings/wk/division (not including teleconferences) • FDAMA (1997): Early Collaboration meetings became regulation (Agreement, Determination meetings) AdvaMed October 17, 2005 -- PreIDEs

  3. Why Pre-Submission Discussions? • Benefits (to sponsors and FDA) • Design testing and development plans that will expedite review and approval • Save money and time • More collaborative approach • Minimize surprises • Cost (to sponsors and FDA) • Time and effort • Money AdvaMed October 17, 2005 -- PreIDEs

  4. Advice may be requested at any of these points in premarket phase: • Prior to conducting “proof of concept” animal studies • Preclinical • Prior to expanding clinical trials from feasibility to pivotal phase • Pre-PMA • Day 100 PMA meetings • Post-deficiency letter for 510(k) or PMA • Appeal a final decision on a PMA or 510(k) or an IDE disapproval • Agreement or determination meeting AdvaMed October 17, 2005 -- PreIDEs

  5. Prior to Proof of Concept • Discuss concepts, broad outline of test plan, bench test methodologies (e.g., use of consensus standards, need for animal studies, need for clinical studies) • Discuss possible regulatory pathways • Discuss potential combination product issues • Face-to-face meetings are usually not held at this stage (premature). AdvaMed October 17, 2005 -- PreIDEs

  6. Preclinical phase • Prototype evaluated in preliminary animal models • Proposed clinical application (possibly not specific patient population) and indication for use • FDA feedback on: • Bench testing plan – methods, standards • Animal study protocols • Feasibility study protocols • Preliminary guidance on SR/NSR (need for IDE) • Preliminary (non-binding) guidance on regulatory pathway • Feedback dependent on focused questions • PreIDE meetings/teleconferences encouraged at this stage AdvaMed October 17, 2005 -- PreIDEs

  7. Prior to initiating pivotal trials • Feasibility studies completed (or nearly so) • Device design finalized to extent possible • Animal studies completed (or in follow-up) • Pivotal trial protocol “fleshed out” (including 1º and 2º endpoints, duration, evaluation methods, statistical analysis) • Specific indication for use (and patient population) determined AdvaMed October 17, 2005 -- PreIDEs

  8. Prior to initiating pivotal trials (cont.) • FDA will give feedback on: • Need for further bench/animal studies • Need for pilot study prior to initiating pivotal study • Proposed pivotal study protocol: endpoints, duration, evaluation, statistical analysis plan • Proposed regulatory pathway • Proposed indication for use • Preliminary nonbinding feedback on expedited status, need for advisory panel meeting • Feedback dependent on focused questions • Meetings/teleconferences with FDA encouraged at this stage AdvaMed October 17, 2005 -- PreIDEs

  9. Scheduling informal pre-IDE meetings (not determination or agreement meetings) • Planning/scheduling may be done by project manager (usually 3-4 weeks after preIDE received) • Complete pre-meeting package needed before meeting will be scheduled • Divisions may have checklists/other guidelines for what is expected in pre-meeting package: Check! • Expect meeting to be cancelled/postponed if extensive new information submitted after meeting scheduled AdvaMed October 17, 2005 -- PreIDEs

  10. Pre-IDEs: What they are and what they are not • Tool to provide informal feedback on: • Preclinical test plan • Clinical/statistical test plan • NSR/Exempt investigations • OUS investigations • NOT intended to be: • A tool for negotiation • An iterative process • Modular review • Review of data (“pre-510(k)”, “pre-PMA”) • As in depth as an IDE or marketing application review • Legally binding • Method for dispute resolution AdvaMed October 17, 2005 -- PreIDEs

  11. Recommendations • FDA is doing our homework before your meeting; please do yours! • Think carefully about what you want to get from a meeting – are you ready to talk with FDA? • If you must make changes to device or protocol after pre-IDE package has been submitted, be prepared to cancel and reschedule • Manage your meeting time carefully • Bring right people to discuss focused questions • Ask for clarification AdvaMed October 17, 2005 -- PreIDEs

  12. Recommendations • Do not expect FDA to: • Make guarantees or binding commitments (unless it is a determination or agreement meeting) • Approve study or clear/approve device at meeting • Act as a consultant • Give special treatment or favors • Hold to informal feedback provided years ago – technology does not stay constant • Have a series of meetings on the same topics – make the most of THIS meeting AdvaMed October 17, 2005 -- PreIDEs

  13. More Information • October 10, 2007 Federal Register Notice: • List of Guidance Documents under review in CDRH • Pre-PMA and Pre-IDE Meetings • http://www.fda.gov/cdrh/mdufma/guidance/agenda/fy08.html • CDRH Website: Device Advice http://www.fda.gov/cdrh/devadvice/ AdvaMed October 17, 2005 -- PreIDEs

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