Got Patient Care Ideas? FDA Wants to Hear Them

Article title
logo

Got Patient Care Ideas? FDA Wants to Hear Them | AssurX Quality Management System QMSAs 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.

With decades of expertise built into our quality management and regulatory compliance software, the AssurX Quality Management Software Platform helps companies maintain quality and compliance standards, streamline workflow and better manage any enterprise. Our configurable software and understanding of users’ needs produce a unique system that easily adapts as a customer’s business evolves. AssurX is an ideal partner for regulated companies looking for better operational control and efficiency while staying compliant. To learn more, visit: www.assurx.com.

Summary
Got Patient Care Ideas? FDA Wants to Hear Them
Article Name
Got Patient Care Ideas? FDA Wants to Hear Them
Description
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.
Author
Publisher Name
AssurX
Publisher Logo
Quality Management Software
AssurX Quality + ComplianceA single versatile software system can improve quality, compliance and streamline workflow.
Don’t Miss A Post

Subscribe to our blog to receive an email when we publish new content.

Quality Management Software
AssurX Quality + ComplianceA single versatile software system can improve quality, compliance and streamline workflow.