Clinical Decision Support Software
This guidance clarifies the scope of FDA’s oversight of clinical decision support software intended for health care professionals (HCPs) as devices.
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FDA Roundup: January 19, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. -
FDA Roundup: July 14, 2023
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. -
FDA Roundup: July 23, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. -
Absolutely Natural – 715690 – 12/30/2025
CGMP/Finished Pharmaceuticals/Adulterated -
List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic
The FDA maintains a list of approved new drug application (NDA) drug products that are no longer protected by patents or exclusivities, and for which the FDA has not approved an ANDA referencing that NDA drug product. -
LiquidCapsule Manufacturing, LLC – 717069 – 12/19/2025
CGMP/Finished Pharmaceuticals/Adulterated -
Tower Laboratories Ltd. – 717456 – 12/23/2025
CGMP/Finished Pharmaceuticals/Adulterated -
Diagnostic Intravascular Catheter Recall: Conavi Removes Novasight Hybrid Catheters
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program -
Infusion Pump Software Recall: Baxter Removes Sigma Spectrum Infusion System Platforms
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program -
Intravascular PICC Catheter Recall: Bard Removes PowerPICC Intravascular Catheters
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program -
Aspiration System Correction: Calyxo Updates Use Instructions for CVAC Aspiration Systems
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program