Safety and Performance Based Pathway
Posts published in “United States Food and Drug Administration – US FDA”
Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health
Safer Technologies Program for Medical Devices
Special Premarket Notification [510(k)] Pathway
Cybersecurity in Medical Devices: Communication That Empowers Patients.
Consideration of Benefit-Risk Approaches for Weight-Loss Devices
Acceptance Review for De Novo Classification Requests
Humanitarian Device Exemption (HDE) Program
The FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication
Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions