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From Health Law Daily, September 21, 2015

New committee to facilitate patient engagement regarding device regulation

By Kayla R. Bryant, J.D.

A Patient Engagement Advisory Committee has been established by the FDA to advise the agency on medical device issues. The committee will have the freedom to consider agency guidance, clinical trials, patient study design, labeling, clinical needs, alternatives, and various patient-related topics. The agency is requesting comments no later than November 20, 2015, on how it should engage patients and sponsors in the process of testing and approving devices (Notice, 80 FR 57007, September 21, 2015).

Committee. The FDA commissioner will select nine voting members from various experts in the field to serve as the core of the committee. The members will be experienced in clinical research, health care needs of various patient groups, and communicating with patients about their needs. The members will serve for terms of up to four years. Additionally, the commissioner may select non-voting members to serve on a temporary basis from a group of individuals nominated by the industry. According to the agency, the committee will provide relevant perspectives in order to improve communication with patients about the regulatory process for devices.

Patient preference. The agency is attempting to shift from reliance upon expert opinions to a more patient-centered approach, as patients are becoming increasingly active in making choices about their care. The agency believes that patient preference data can be used to help identify which risks and benefits are most important from a patient’s perspective, assess how patients view the tradeoff of risks and benefits, and understand how patient preferences vary.

Comments. The FDA has created a non-inclusive list of questions on which it is soliciting responses, such as:

  • How should FDA engage patients for input related to medical device performance once products are available on the market?

  • How should labeling indicate that only a portion of patients in a patient preference study were willing to accept certain risks in order to achieve probable benefits?

  • How do patients view clinical study informed consent forms?

The agency is also requesting nominations for voting members, individuals and consumer organizations, and individuals and industry organizations.

MainStory: TopStory MDeviceNews ClinicalNews

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