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Should Patients Have a Say in Medical Device Regulatory Matters?

FDA has opened a docket to receive input from the public on a new priority list of patient preference-sensitive areas that may impact the design and conduct of premarket medical device clinical studies, benefit-risk assessments, and postmarket evaluation.

FDA continues to make surprising moves in 2019. On Thursday, the agency opened a docket to receive input from the public on a new priority list of patient preference-sensitive areas that may impact the design and conduct of premarket medical device clinical studies, benefit-risk assessments, and postmarket evaluation.

The priority list, developed based on public input the agency previously received, is intended to provide greater clarity about areas in which FDA would find patient preference information most informative for medical device regulatory decisions.

“Patients are the experts in living with their disease or condition, the outcomes that are most important to them, and how they weigh benefits and risks," said Jeff Shuren, director of the FDA's Center for Devices and Radiological Health. "Through our Patient Preference Initiative, we’ve committed to seeking patient input on these types of topics to help inform our regulatory decision making. Through better collection and understanding of information that matters to patients, we can ensure our evaluation throughout the lifecycle of a medical device includes a better reflection of the patient experience."

Shuren said that by asking patients, industry members, and researchers to provide comments and feedback on the list of patient preference areas, FDA is working to ensure that the "valuable insights from patients continue to inform the agency's decisions and understanding."

In addition to the identified patient preference-sensitive topics listed, FDA asked for feedback from the public on whether the list itself needs to be modified. The agency said it is interested in information about existing studies that may already be available to help address the information FDA is seeking.

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