FDA Publishes Guidance On Radiology Images And Device Data For Submitting 510(k)s
The US FDA has updated guidance on computer-assisted detection devices that was first released in 2012. The document, which is intended to help developers win FDA approval of their products, was last updated in 2020.
You may also be interested in...
To mesh with a final order reclassifying medical-image analyzers, the US agency has also published a final guidance on computer-assisted detection (CADe) devices that was first finalized more than six years ago.
Now that the CHIPS and Science Act is law, AdvaMed wants the Biden administration to use it to ensure device makers get the semiconductor chips they need for their products while preventing the US from facing another shortage of the essential components, as experienced during the pandemic.
Compatibility Issues With Some LAV Connectors And Prefilled Syringes Can Interrupt Drug Delivery, FDA Warns
The US FDA says issues with certain LAV connectors attached to prefilled glass syringes may cause clogging and prevent the proper administration of drugs. This could result in serious harm, especially during emergencies.