Tag: De Novo classification
FDA has begun requiring electronic De Novo submissions for new medical devices
Editor's Note Beginning October 1, the Food and Drug Administration (FDA) is mandating that all De Novo classification requests be submitted electronically using its eSTAR system, according to a final rule and guidance issued by the agency. As detailed in the September 30 release, the shift marks a procedural change…
Free Daily News
- FDA has begun requiring electronic De Novo submissions for new medical devices
- Spine surgeon shortage deepens as consolidation, site shifts reshape ASC markets
- Study: Outpatient surgery costs hinge on site of care, network status
- Private equity is reshaping ASCs, raising cost and antitrust concerns
- CDC shifts COVID-19 vaccination to individual decision-making, separates chickenpox shot for toddlers
- 31,000 Kaiser nurses, healthcare workers prepare for historic strike
- Guideline refines surgical decision-making for patients with cirrhosis
- Cuts to NIOSH, OSHA threaten decades of worker-safety progress
- No BLS report: Government shutdown stalls key jobs report amid signs of labor market weakness
- AI-powered video models show promise for nursing skills assessment
© Access Intelligence, LLC. All rights reserved. |
Privacy Policy |
Cookie Settings |
Diversity, Equity, Inclusion & Belonging |
Accessibility Statement