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
- New studies highlight opportunities to improve pediatric anesthesia safety, comfort
- Social and behavioral factors emerging as key predictors of recovery quality after surgery
- Hospitals being squeezed: Anesthesia workforce gaps, payer cuts threaten surgery access
- CDC layoffs cripple national injury and overdose tracking, leaving prevention efforts in doubt
- The Joint Commission makes nurse staffing a national performance goal for 2026
- Telehealth in limbo: Providers split on continuing Medicare services during shutdown
- States take aim at outpatient facility fees driving higher commercial health costs
- Slower acquisitions, mounting debt reshape Surgery Partners growth outlook
- ASCs surge as hospitals and investors chase outpatient growth
- Nearly half of US physicians now work for large systems: GAO links consolidation to higher costs
© Access Intelligence, LLC. All rights reserved. |
Privacy Policy |
Cookie Settings |
Diversity, Equity, Inclusion & Belonging |
Accessibility Statement