understanding the pre-ide program: fda perspective capt stephen p. rhodes, usphs director, ide and...

Understanding the Pre-IDE Program: FDA Perspective

CAPT Stephen P. Rhodes, USPHSDirector, IDE and HDE ProgramsOffice of Device Evaluation

AdvaMed AudioConferenceOctober 17, 2007

AdvaMed October 17, 2005 -- PreIDEs

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)


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


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


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).


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


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


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


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


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


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


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


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/