This paper is not intended to propose or implement policy changes regarding how CDRH intends to regulate generative AI-enabled devices. This paper is not
intended to communicate CDRH’s proposed (or final) regulatory expectations, including its expectations for supporting evidence in future marketing submissions, but is instead
meant to seek early input from groups and individuals outside the Agency and to advance a broader discussion among stakeholders on this topic.
As with all medical devices, CDRH anticipates applying a risk-based approach to regulating GenAI-enabled devices, taking into consideration the product’s intended use
and technological characteristics. Furthermore, CDRH has long promoted a total product life cycle (TPLC) approach to the regulation of medical devices, including AIenabled devices, and a TPLC approach is likely to be important to the regulation of GenAI-enabled devices
This paper is intended for discussion purposes only and does not represent draft or final guidance.