FDA Cares What Patients Think About Devices
Wednesday, May 13, 2015
FDA is showing that it takes patient input and preferences seriously, by giving the medical device industry new draft guidance on the role of patient preference information in the review process and the product development process. The draft guidance, "Patient Preference Information—Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device Labeling," outlines best practices for patient preference studies and data collection, and how best to incorporate the information in labeling.
This isn't the first time FDA has shown interest in patient preference information. In 2012 FDA published guidance on the patient perspectives that may be considered by agency reviewers, including patient tolerance for risk and perspective on benefit. This new draft guidance sticks to considering patient risk tolerance and benefit perspective, and emphasizes that submitting such information is voluntary for device sponsors. FDA believes such information could be useful because it helps reviewers understand how patients prioritize certain risks and benefits and how widespread these views are among the patient group. In addition, the guidance states that devices may be better suited than drugs for patient preference information "because the mechanism of action for devices is often well-characterized and fairly localized," unlike drugs.