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Biosimilars 1

Bioresearch Monitoring Program Inspections: Processes and Procedures for Site Evaluations (DRAFT) Jun 5, 2024

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Modular Submissions for Premarket Approval Applications and Humanitarian Device Exemptions
Content of Premarket Submissions and Lifecycle Management for Artificial Intelligence and Machine Learning-Enabled Medical Devices (DRAFT)
Evaluation of Sex and Gender Differences in Medical Device Clinical Studies (DRAFT)
Notifying Device Supply Disruptions and Manufacturing Discontinuances During Public Health Emergencies
Performance Testing and Labeling Requirements for Pulse Oximeters with Focus on Accuracy Across Skin Pigmentation (DRAFT)

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Medical Devices Premarket Biologics Drugs 510(k) Radiation-Emitting Products Administrative / Procedural Good Clinical Practice (GCP) Postmarket Labeling

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Medical Devices Premarket Biologics Drugs 510(k) Radiation-Emitting Products Administrative / Procedural Good Clinical Practice (GCP) Postmarket Labeling

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