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Guidance: What The Patient Prefers, And How To Make It Part Of Your FDA Submission

FDA draft guidance lays out how to collect patient preference data and how to present the preferences on device labels. The guidance supports a growing emphasis by FDA to formally incorporate patient input into regulatory decision-making.

CDRH instructs sponsors on how to collect patient preference information, and then incorporate that data into device submissions seeking FDA approval in a May 13 draft guidance

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