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Pharma Compliance Info FDA to establish patient advisory committee on medical devices Marketing & Market Access

FDA to establish patient advisory committee on medical devices

The U.S. Food and Drug Administration on Friday announced the establishment of its first-ever patient advisory committee on medical devices.
The new 11-member group will include nine voting members “knowledgeable in areas such as clinical research, primary care patient experience and health care needs of patient groups in the United States.” The committee will also have one nonvoting “consumer representative,” and one nonvoting “industry representative.”
The committee, according to the FDA, is designed to inject a patient perspective into the agency’s deliberations on device development, approval and monitoring. The FDA says the committee will help the government “meet its public health commitment to improve patient health and quality of life.”
Among other things, the committee will offer suggestions about FDA policies and rules and designs for clinical trials and device labels. It also will examine ways to determine patient preferences, how to best report patient experiences with medical devices and how to remedy unmet clinical needs.
To read the article by Jim Spencer

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