Seeking to add patient perspective to its regulatory functions, the U.S. Food and Drug Administration is setting up a panel to advise the agency on the use and regulation of medical devices.
"Although it may seem odd in retrospect, the development of new technologies intended to improve patients' lives has largely relied upon expert opinions rather than asking patients and families directly what they consider most important," Nina L. Hunter, a regulatory Scientist in FDA's Center for Devices and Radiological Health, and Robert Califf, FDA's Deputy Commissioner for Medical Products and Tobacco, write in a blog post announcing the Patient Engagement Advisory Committee.
Patient viewpoints will be most useful, the authors say, in ways including:
- To help identify the most important benefits and risks of a technology from a patient's perspective
- To assess how patients think about the tradeoffs between benefits and risk benefits for a given technology
- To help understand how patient preferences vary across a population
The committee will discuss issues such as where and how best to engage patients across the device development and assessment lifecycle, and how FDA and sponsors should communicate patient preference information to patients.
The FDA "may consider rigorous, systematically gathered patient preference information as a part of the totality of the evidence from clinical and nonclinical testing. However, patient preference information will not be used to justify approval of unsafe or ineffective devices," the authors state.
The committee will consist of a core of nine voting members, including the chair, all selected by the commissioner or designee from experts who are knowledgeable in areas such as clinical research, primary care patient experience, and health care needs of patient groups in the United States, according to an announcement.
Too many apps, tools and technologies are entering the healthcare marketplace without proof that they help consumers live healthier lives, Richard Milani, chief clinical transformation officer at Ochsner Health System wrote recently in Fortune.
Even high-risk medical devices lack proper verification of effectiveness and safety, according to a article in the Journal of the American Medical Association.