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FDA Guidance Encourages Companies To Include Patient Preferences In Submissions

 
• By Brian Bossetta

The US FDA has issued a draft guidance document providing recommendations on how device firms can collect patient preference data to share with the agency as it reviews applications. The current draft supersedes final guidance the agency published in 2016.

Patient Data
• Source: Shutterstock

New draft guidance from the US Food and Drug Administration urges medical device firms to incorporate patient preference information (PPI) in the development and evaluation of their products.

The draft document, “Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle,” supersedes final guidance the FDA issued in 2016 which the agency published to help sponsors use patient preferences to strengthen their applications

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