Team-NB Position Paper on Documentation Requirements for Drug Device Combination Products Falling in the Scope of Article 117 of MDR 2017/745.
Posts published in “United States Food and Drug Administration – US FDA”
FDA Issues Immediately in Effect Guidance on Ventilators During COVID-19
Ventilator Supply Mitigation Strategies – Letter to Health Care Providers
Update on the Ethylene Oxide Sterilization Master File Pilot Program
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
Soft (Hydrophilic) Daily Wear Contact Lenses – Performance Criteria for Safety and Performance Based Pathway