FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

CDRH Focuses on Patient Preference in IDE Applications

March 6, 2017
A A

CDRH officials reiterated that investigational device exemption applications should include information on patient preferences.

Patient perspectives are vital for determining the risks and benefits of IDE applications, said Karen Ulisney, a policy analyst in CDRH’s Office of Device Evaluation, in a webinar on the agency’s January IDE guidance.

Additional patient information could include electronic tools such as charts and graphs to enhance informed consent, as well as patient-reported outcomes, and information about how patients experience using a particular device.

View today's stories