The FDA announces its first Patient Engagement Advisory Committee.


As promised, the FDA just announced its first Patient Engagement Advisory Committee, designed to bring together patients, advocacy groups, and experts to discuss complex patient care issues including regulation of medical devices.

The Committee will have nine voting members, along with a non-voting industry representative and one non-voting consumer rep. It is expected to meet twice a year, with the possibility of adding subcommittee’s as deemed necessary.

In addition to device labeling and device-related quality of life issues, the Center for Devices and Radiological Health (CDRH) could ultimately seek counsel from the Committee in a number of areas, including:

  • Agency guidance and policies
  • Clinical trial or registry design
  • Patient preference study design
  • Benefit-risk determinations
  • Unmet clinical needs
  • Patient reported outcomes

CDRH is hoping to find experts in several arenas, including:

  • Strategies for communicating benefits, risks and clinical outcomes to patients and research subjects
  • Primary care patient experience
  • Healthcare needs of various patient groups across the U.S.
  • The work of patient and health professional organizations
  • Clinical research

To nominate yourself or a colleague, click here.

About AssurX, Inc.
AssurX, Inc. provides global companies with enterprise quality management systems and regulatory compliance software solutions. AssurX’s flexible, all-in-one system automates quality and compliance related processes so issues can be centrally managed—from detection to corrective action and trend analysis. It helps collect, organize, analyze and share information to better manage risk and improve quality and compliance performance everywhere in the enterprise.

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