Best Practices for Effective and Productive Premarket Meetings with
CDRH
(Text Version) |
|
OMO/Analysis Branch in conjunction with OCD
June 2004
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
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
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…
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
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
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.
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
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
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
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
Updated: January 18, 2005
CDRH Home Page | CDRH A-Z Index | Contact CDRH | Accessibility | Disclaimer
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | HHS Home Page
Center for Devices and Radiological Health / CDRH