Application of Risk Management Principles for Medical Devices
This CDRH Learn module explains U.S. FDA's thoughts on the application of risk management principles for medical devices. It provides important information on risk analysis tools and review of benefit-risk information, including concepts from ISO 13485:2019. To view more educational resources please visit https://www.fda.gov/training-and-cont....
▶︎
Risk Basics for Medical Devices
▶︎
AGDD 2025 | D2S04 - Nitrosamines: Known Issues and Practical Advice
▶︎
Is My Product A Medical Device
▶︎
Commissioner’s National Priority Voucher (CNPV) Pilot Program Public Hearing
▶︎
FDA Grand Rounds - Clinical Omics Biomarker Discovery and Validation in Precision Medicine
▶︎
OTP Town Hall: Best Practices for Preparing BLA Submissions for Cell and Gene Therapy Products
▶︎
Understanding the Nutrition Facts Label, the Updated “Healthy” Claim, and Other Nutrition Claims
▶︎
ClinicalTrials.gov: Essentials for Academic Medical Centers – Pre-recorded Training Video
▶︎
AGDD 2025 | D2S03 - Common Deficiencies and Resolutions: Complex Drug Substance/Excipients/Products
▶︎
AGDD 2025 | D1S01 - Product-Specific Guidance for Complex Products: From Research to Standards
▶︎
FDA Direct: Combating Rare Diseases at the FDA
▶︎
How is CDRH Structured?
▶︎
FDA Grand Rounds - Pharmacovigilance in Practice: From Safety Signals to Regulatory Action
▶︎
AGDD 2025 | D1S02 - Session 2: Q&A Discussion Panel
▶︎
CDRH - REdI Annual Conference 2026: Innovative Regulatory Strategies to Advance Medical Products
▶︎
FDA Direct: These 9 Drugs Were Awarded National Priority Vouchers
▶︎
Conversations on Cancer: Patient first = Project Facilitate
▶︎
AGDD 2025 | D2S04 – Session 4: Q&A Discussion Panel
▶︎
VRBPAC -- May 28 Meeting
▶︎