FDA Issues Immediately in Effect Guidance on Ventilators During COVID-19
Posts tagged as “US FDA”
Ventilator Supply Mitigation Strategies – Letter to Health Care Providers
FDA Engagement to Mitigate Potential Shortage of Personal Protective Equipment (PPE)
FDA Issues Final Guidance on the 510(k) Third Party Review Program
Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
FDA issues “Guidance on Conduct of Clinical Trials of Medical Products During the COVID-19 Pandemic”
Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery
Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior
Soft (Hydrophilic) Daily Wear Contact Lenses – Performance Criteria for Safety and Performance Based Pathway
Bone Anchors – Premarket Notification (510(k)) Submissions