US FDA Forming Patient Engagement Committee on Medical Devices

The US Food and Drug Administration has begun forming a new Patient Engagement Advisory Committee (PEAC) to improve communications with patients and users on various clinical and regulatory issues involving medical devices.

FDA Patient Engagement Advisory Committee (PEAC) to advise on medical device registration determinationsAccording to the FDA’s announcement and accompanying blog post, the formation of the new committee reflects a trend toward “patient-centered” healthcare in which the agency will make more of an effort to include patient perspectives in regulatory and clinical processes.

As planned, the PEAC will have nine voting members appointed by the FDA commissioner from clinical research, primary care and patient advocacy sectors. The commissioner may also appoint non-voting members nominated by industry participants to attend individual PEAC meetings.

Issues on which the PEAC will advise the FDA include:

  • FDA guidance and policies
  • Underserved or unmet clinical needs
  • Clinical study design
  • Available alternative treatments
  • Benefit-risk determinations
  • Patient-reported outcomes
  • Device labeling
  • Quality of life issues

 

Although the FDA emphasizes greater consideration of issues such as patient preference information in its device clearance and approval determinations, the agency clearly states on its blog that such information will not trump scientific and clinical data when it comes to market authorization decisions:

“However, patient preference information will not be used to justify approval of unsafe or ineffective devices: if FDA determines the device would expose patients to an unreasonable or significant risk of illness or injury, or that the benefits do not outweigh the risks for a defined target population, FDA would not approve such a device.”
 

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