June 12, 2017
FDA extends UDI compliance dates for Class I, unclassified devices
Editor's Note
The Food and Drug Administration (FDA) has notified medical device labelers that the compliance dates for unique device identifier (UDI) requirements for Class I and unclassified medical devices has been extended from September 24, 2018, to September 24, 2020, and for direct mark requirements from September 24, 2020, to September 24, 2022.
The extensions were made in response to industry concerns about meeting compliance dates and to resolve higher-risk device issues before adding lower-risk devices to the UDI system.
Free Daily News
- Kentucky Derby, SPD race: Leadership lessons energized SPD professionals at HSPA 2025
- Continuum-based protocol offers new strategy for preventing PONV after thyroidectomy
- Pembrolizumab sets new standard in advanced head and neck cancer surgery, trial shows
- Subarachnoid spinal anesthesia offers safe, effective option for high-risk obstetric patients
- Same-day discharge after catheter ablation gains backing from top cardiology societies
- Tenet, HCA post strong Q1 results, but caution looms over policy uncertainty, outpatient trends
- Telemedicine transforms postoperative care through safer, faster, patient-centered recovery
- ASCA conference coverage to keep ASC leaders informed
- Study: Prolonged COVID symptoms more likely for healthcare workers
- Study: Patients of female surgeons experience fewer complications, lower long-term readmission
© Access Intelligence, LLC. All rights reserved. |
Privacy Policy |
Cookie Settings |
Diversity, Equity, Inclusion & Belonging |
Accessibility Statement