Tag: Computer-Assisted Detection Devices

Recently Posted FDA Guidance Documents

1/24/2020 –¬†Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment: Guidance for Industry 1/22/2020 –¬†Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data – Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions: Guidance for Industry and FDA Staff […]

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