Risk Basics for Medical Devices
This CDRH Learn module explains U.S. FDA's thoughts on the basics of medical device risk. It provides important definitions, describes basic concepts and lays foundational knowledge on the topic of risk and its use throughout the total product life cycle. To view more educational resources please visit https://www.fda.gov/training-and-cont....
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Application of Risk Management Principles for Medical Devices
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FDA Direct: Citrus Regs, Natural Dye Pledges, and Hidden Opioids
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CDRH Patient Education Program: Patients as Advisors in Medical Device Clinical Studies
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Medical Device Quality Management System Regulation Risk Management
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ClinicalTrials.gov: Essentials for Academic Medical Centers – Pre-recorded Training Video
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FDA Direct: These 9 Drugs Were Awarded National Priority Vouchers
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FDA Direct: An Eye on CDRH: Regulating for a New Era of Medical Devices
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Understanding the Nutrition Facts Label, the Updated “Healthy” Claim, and Other Nutrition Claims
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FDA Direct: Faster Reviews, Food Dye Wins and Protecting American DNA
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CDER - REdI Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products
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CDRH - REdI Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products
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FDA Direct: Combating Rare Diseases at the FDA
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Cybersecurity Awareness for Connected Medical Devices
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OTP Town Hall: Best Practices for Preparing BLA Submissions for Cell and Gene Therapy Products
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FDA Direct: The Power of Real-Time Clinical Trials
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FDA Grand Rounds - Clinical Omics Biomarker Discovery and Validation in Precision Medicine
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How is My Medical Device Classified?
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FDA Direct with Dr. Martin Makary, FDA Commissioner
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Commissioner’s National Priority Voucher (CNPV) Pilot Program Public Hearing
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