FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH

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