Per the notice below, the United States Food and Drug Administration (FDA) has issued draft guidance for public comment on incorporating voluntary patient preference information in the FDA regulatory approval process.

FDA Issues Draft Guidance on Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle

Today, the U.S. Food and Drug Administration (FDA) issued this draft guidance: Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle.  This guidance, when finalized, is intended to provide recommendations on how patient preferences can be collected and shared with the FDA and be considered in the decision-making process.  It also provides recommendations on the types of patient preference studies that can provide reliable scientific evidence.

Facts about the draft guidance

This draft guidance, when finalized, is intended to:

• Encourage medical device companies to use patient preference information to inform the entire product lifecycle.
• Supersede 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.
• Revise the 2016 guidance to provide additional considerations and practical recommendations based on additional experience evaluating patient preferences regarding devices.

Note: This guidance is not for implementation at this time.

Submit comments on this draft guidance

Submit comments under docket number FDA-2015-D-1580 at www.regulations.gov by November 5, 2024, to ensure the FDA considers comments on this draft guidance before it begins work on the final version of the guidance.

Upcoming Webinar on this guidance

On October 15, 2024, the FDA will host a webinar for industry and other parties interested in learning more about the draft guidance.

Questions?