«

»

May 06

Device Advisory Committee Changes

If you don’t like how things are, change it!  You’re not a tree.

– Jim Rohn

Planning on attending an Advisory Committee meeting for a medical device in the near future?  If you’re a regular at them, you may soon notice something different.  The FDA’s Center for Devices and Radiological Health (CDRH) recently announced some changes it is making to the way device Advisory Committees will operate.  Hopefully, these changes will increase transparency and help assuage some of the (pointed) observations about a perceived disconnect between some statements by panel members and their final vote.

Summary of Changes:

  • The panel staff has been centralized to improve continuity.
  • Voting will now be done by ballot, not by a show of hands.  Ballot results will be tallied and revealed at the meeting.  Each panel member’s vote will become public.  (Presumably this is to limit the appearance of peer pressure during voting.)
  • Panels will give their opinions and recommendations to the questions posed by the FDA without interruption.
  • Panels will vote only on the safety and effectiveness of the device in question (i.e., risk vs. benefit).  Previously, panel members voted on whether they thought the device should be approved.
  • CDRH will no longer present a single, consolidated analysis.  Differing opinions between CDRH reviewers, if any, are now allowed to be expressed.

The last one is the biggest and is clearly a response to accusations levied against CDRH in the last year or so.  Allowing, maybe even encouraging, different reviewer opinions to be voiced in public should go a long way towards pulling back the veil that critics accuse CDRH of operating behind.  It’s not likely to be extended to other types of AdComms any time soon, but if this helps restore faith in CDRH, we may eventually see a broader application.

If you’d like to read more about this, Mark Senak has a good write up about some of the history that led to these changes over on Eye on FDA.

If you don’t like how things are, change it! You’re not a tree.

– Jim Rohn

Planning on attending an Advisory Committee meeting for a medical device in the near future? If you’re a regular at them, you may soon notice something different. The FDA’s Center for Devices and Radiological Health (CDRH) recently announced some changes it is making to the way device Advisory Committees will operate. Hopefully, these changes will increase transparency and help assuage some of the (pointed) observations about a perceived disconnect between some statements by panel members and their final vote.

Summary of Changes:

· The panel staff has been centralized to improve continuity.

· Voting will now be done by ballot, not by a show of hands. Ballot results will be tallied and revealed at the meeting. Each panel member’s vote will become public. (Presumably this is to limit the appearance of peer pressure during voting.)

· Panels will give their opinions and recommendations to the questions posed by the FDA without interruption.

· Panels will vote only on the safety and effectiveness of the device in question (i.e., risk vs. benefit). Previously, panel members voted on whether they thought the device should be approved.

· CDRH will no longer present a single, consolidated analysis. Differing opinions between CDRH reviewers, if any, are now allowed to be expressed.

The last one is the biggest and is clearly a response to accusations levied against CDRH in the last year or so. Allowing, maybe even encouraging, different reviewer opinions to be voiced in public should go a long way towards pulling back the veil that critics accuse CDRH of operating behind. It’s not likely to be extended to other types of AdComms any time soon, but if this helps restore faith in CDRH, we may eventually see a broader application.

If you’d like to read more about this, Mark Senak has a good write up about some of the history that led to these changes over on Eye on FDA.