The FDA has entered into the federal register a new draft guidance pertaining to "software as a medical device" (SaMD). The guidance is presented as representing the FDA's current thinking on ...

This morning the FDA released two guidance documents relating to the regulation of various digital health software devices. The first is a draft guidance outlining categories of clinical decision ...

The Internet and the always connected world have significantly improved medical care with devices that can transmit patient data in real-time to caregivers. But with this growing reliance on software ...

On January 6, 2024, FDA released draft guidance on Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (the “draft guidance”). The ...

We are very proud of this result. A no‑483 outcome is a testament to the discipline, expertise, and dedication of our ...

Medical device manufacturers that want to avoid a long deficiency letter will want to pay close attention to FDA’s final cybersecurity guidance, updated in June 2025 (and again in February 2026).