Aggregator

FDA Publishes Discussion Paper on Regulating Generative AI-Enabled Med Devices

1 month ago

The FDA has opened a discussion on how generative AI-enabled medical devices should be assessed, evaluated, and monitored. The paper raises pointed questions for manufacturers about risk, premarket review, and postmarket performance of these emerging devices.

The post FDA Publishes Discussion Paper on Regulating Generative AI-Enabled Med Devices appeared first on In Compliance Magazine.

In Compliance