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Guidance Documents/Guidance-Document/Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation: Guidance for Industry and Food and Drug Administration Staff, And Other Stakeholders

Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation: Guidance for Industry and Food and Drug Administration Staff, And Other Stakeholders

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

January 26, 2022

January 25, 2022

Center for Devices and Radiological Health

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