Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation

On 26 January 2022 the FDA issued the final guidance for industry, FDA staff, and other stakeholders.

FDA is issuing this guidance to describe principles that should be considered when using Patient-Reported Outcome (PRO) instruments in the evaluation of medical devices and provide recommendations about the importance of ensuring the measures are fit-for-purpose. This guidance is not meant to replace the Patient-Focused Drug Development (PFDD) guidance series.

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