FDA Prepares to Tackle Oversight of AI-Enabled Mental Health Devices
Roger Baits, Contributing Editor
The U.S. Food...
Tag: U.S. Food and Drug Administration
Former Employee of Medical Device Manufacturer Sentenced for Forging Two FDA Letters that Led to Illegal Sale of Medical Devices
The Justice Department announced that a federal...
FDA and CMS Statement: Americans Deserve Accurate and Reliable Diagnostic Tests, Wherever They Are Made
The following is attributed to Jeff Shuren,...
FDA Authorizes Florida’s Drug Importation Program
The U.S. Food and Drug Administration...
Former Employee of Medical Device Manufacturer Pleads Guilty to Forging Two FDA Clearance Letters for Medical Devices
A Philadelphia-area man pleaded guilty for his...
Illumina Cybersecurity Vulnerability Affecting the Universal Copy Service Software May Present Risks for Patient Results and Customer Networks: Letter to Healthcare Providers
The U.S. Food and Drug Administration (FDA) is...