Best Practices for Effective and Productive Premarket Meetings by kumar12

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									 Best Practices for
   Effective and
    Productive
Premarket Meetings
    with CDRH
OMO/Analysis Branch in
 conjunction with OCD

      June 2004

                         1
                Purpose
Objective
– Provide Ombudsman and other CDRH staff
  with best practices to advise device firms and
  sponsors to follow when preparing for and
  attending premarket meetings with CDRH
Customer
– Les Weinstein, CDRH Ombudsman
Method
– Facilitate two CDRH focus groups to identify
  best practices for device firms and sponsors
                                                   2
Focus Group Demographics
Focus groups held in June 2004
Seventeen participants total
ODE and OIVD represented
Participants included project managers,
reviewers, and Division Directors
Participants’ experience ranged from a few
months to many years

                                          3
These charts are recommendations and
advice, not requirements, guidelines or
SOPs…

  Advice to Industry from CDRH reviewing
  officials on how to have effective and
  productive premarket meetings
  They speak from experience…




                                           4
 Once you decide a meeting is
        necessary…
Determine the scope of the meeting prior
to contacting CDRH
Put request for meeting in writing and
include:
 - Scope of meeting
- Audio/visual equipment needs
Send background package with request or
immediately after request is acknowledged

                                           5
    Background Package is extremely
             important…
    Should include:
     – scope of the meeting
     – agenda
     – list of attendees
     – specific questions CDRH should address
     – avoid general questions like, “Is the protocol ok?”
    Provide package at least 2 weeks prior to meeting,
    or by date requested, in order for CDRH to fully
    prepare for meeting
    Follow Division-specific procedures where they exist*
*Some Division meetings are more formal/structured than others
                                                                 6
  Presentations Should
be short and to the point
leave time for discussion
focus on scope of meeting and your questions
focus on issues at hand (scientific, regulatory or
administrative)
keep company history to a minimum and make
relevant to agenda
indicate where you are in product timeline
   Please Note: Have handouts and copies of presentation
   available for all attendees at the meeting
                                                           7
          During Meeting

Stick to the designated scope and questions
Limit meeting to 1 hour for presentation,
questions, responses, and action items
Start and end on time
Be open to advice from FDA
Get action items reiterated or recapped at
the end of the meeting
                                             8
                Avoid…
Requesting meeting before you have
adequate information ready to discuss
Surprising CDRH at meeting with new
information not included in background
package, or sending new information just
before meeting. Re-schedule instead
Having side discussions before, during or
after meeting – stick to official agenda and
timeframe
                                               9
  Keep in mind that at meetings
         CDRH cannot:
make guarantees or commitments, see
FDAMA meeting guidance at
http://www.fda.gov/cdrh/ode/guidance/310.html
approve a study or clear/approve device
act as a consultant
give special treatment or favors
hold to feedback provided years ago –
technology does not stay constant
                                                10
            General Advice
Provide several options for dates when
scheduling – be flexible
Begin meeting with an introduction of attendees
- when possible provide business cards
Bring your own laser pointer if needed
If you have to cancel a meeting, do so at least
48 hours ahead
Turn off all beepers, pagers or cells
Get copies of attendance at the end of meeting
                                                  11

								
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