The FDA issued the first warning letter for UDI violations to help ensure compliance
US FDA issued the first warning letter for UDI violations to help ensure compliance
More from Unique Device Identification - UDIMore posts in Unique Device Identification - UDI »
- EU – MDCG 2018-1 v3 Guidance on BASIC UDI-DI and changes to UDI-DI
- EU – Several new UDI-Related documents
- EU – MDR EUDAMED-UDI- Data Dictionary V5.0
- EU – Unique Device Identification (UDI) System – FAQs
- Commission Implementing Decision (EU) 2019/939 of 6 June 2019 designating issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices
More from United States Food and Drug Administration - US FDAMore posts in United States Food and Drug Administration - US FDA »
- EU – Team-NB Position Paper on Documentation Requirements for Drug Device Combination Products Falling in the Scope of Article 117 of MDR 2017/745.
- US – FDA Issues Immediately in Effect Guidance on Ventilators During COVID-19
- US – Ventilator Supply Mitigation Strategies – Letter to Health Care Providers
- US – Update on the Ethylene Oxide Sterilization Master File Pilot Program
- US – FDA Engagement to Mitigate Potential Shortage of Personal Protective Equipment (PPE)
Be First to Comment