- FDA is rolling out a new initiative aimed at getting patient input on issues that may affect regulatory decisions on devices and making device clinical trials more patient-centric.
- The agency announced Thursday it opened a docket to get patient feedback on a priority list of topics of patient preference areas on devices.
- The effort is part of FDA's Patient Science and Engagement program, which seeks to increase patient engagement in medical device decision making and was mandated under 2017 user fee legislation.
Patients' specific preferences could help inform medical device decision making, the agency said, including device design and shaping clinical studies. The agency is seeking input on a patient preference information list to help identify topic areas patients care about the most and which may affect the design and conduct of premarket medical device clinical studies, benefit-risk assessments, and postmarket evaluation.
FDA staff are looking to better understand the full impact of the disease or condition and treatment options on patients and caregivers. For example, the agency said patients might evaluate the benefits and risks of a technology or treatment differently from healthcare professionals and caregivers.
The initiative is part of FDA’s commitments under reauthorization of the 2017 medical device user fees.
The Center for Devices and Radiological Health committed to publish a list of priority areas where preference-sensitive data can inform regulatory decision making.
But at least one health policy analyst said the patient preference list is more likely to help industry than patients.
"I think this is something industry wants to urge the FDA to lower their standards, because the device companies have recruited and trained patients to lobby for the issues that the device industry would benefit from," Diana Zuckerman, president of the National Center for Health Research in Washington told MedTech Dive in an email.
"If you look at what the FDA said, it is clear that they have heard from desperate patients who are willing to take risks with unproven devices, not patients who were harmed by devices and want to urge FDA to have higher approval standards," she said.
Comments on the list are due July 2.