9/13/2019 – Format for Traditional and Abbreviated 510(k)s: Guidance for Industry and FDA Staff 9/13/2019 – Refuse to Accept Policy for 510(k)s: Guidance for Industry and Food…
Posts published in “USA”
Safety and Performance Based Pathway
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