FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

CDRH Focuses on Patient Preference in IDE Applications

March 6, 2017

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.

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