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FDA - PRO Update




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

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/principles-selecting-developing-modifying-and-adapting-patient-reported-outcome-instruments-use

Up front of the PRO Workshop, at which Prof Katharine Barnard-Kelly is an invited speaker and discussion panel member, the FDA have published this important guidance:

The objectives of this guidance are to:

  1. Describe principles that may be considered when using PRO instruments in the evaluation of medical devices (Section III);

  2. Provide recommendations about the importance of ensuring the PRO instruments are fit-for-purpose (Section III), and;

  3. Outline best practices to help ensure relevant, reliable, and sufficiently robust PRO instruments are developed, modified, or adapted using the least burdensome approach (Section IV).

Further information on the workshop, and registration can be found here:

Medical Devices Virtual Public Meeting - Patient-Reported Outcomes (PROs) and Medical Device Evaluation: From Conception to Implementation

SEPTEMBER 30, 2020

https://www.fda.gov/medical-devices/workshops-conferences-medical-devices/medical-devices-virtual-public-meeting-patient-reported-outcomes-pros-and-medical-device-evaluation




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