CDRH New - January 26, 2022

If your email program has trouble displaying this email, view as a webpage. January 26, 2022 The Center for Devices and Radiological Health (CDRH) posted these new items on FDA.gov on January 25, 2022. To view listings for other dates, see CDRH New - News and Updates. 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 Patient Engagement in the Design and Conduct of Medical Device Clinical Studies - Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders CDRH Patient Engagement (Updated) Clinical Outcome Assessments (COAs) in Medical Device Decision Making (Updated) Webinar - Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation - Final Guidance - March 1, 2022 Webinar - Patient Engagement in the Design and Conduct of Medical Device Clinical Studies - Final Guidance - March 22, 2022 Virtual Public Workshop –– Study Design Considerations for Transbronchoscopic Thermal Ablation Devices for the Treatment of Oligometastases to the Lung; April 5 & 6, 2022 Federal Register: Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation Federal Register: Patient Engagement in the Design and Conduct of Medical Device Clinical Studies

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