CDRH Eyes Revisions to Patient Preference Guidance

The Center for Devices and Radiological Health (CDRH) has invited comments on ways to include patient perspectives in medical device approval applications as the center plans to update its current guidance on patient preference information. 

The center has specifically asked for input on methods for eliciting patient preference, what information to provide to the FDA on a patient preference study and examples of patient preference studies that could help support regulatory decisions.

The information will be considered in a proposed revision of the 2016 final guidance, Patient Preference Information — Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling.

Comments on the questions are due by June 6. Read CDRH’s notice here: bit.ly/3GpXXAd.

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