The SARS-CoV-2 pandemic is dramatically changing the landscape of digital healthcare innovation. The FDA has approved emergency use authorization for a variety of SaMD products, including but not limited to mental health care, clinical decision support, and remote monitoring software applications. In addition, the FDA recently launched the Digital Health Center of Excellence, provided updates on the pre-certification program, and hosted a session to convey the FDA's current insights on AI/ML SaMD validation.

SaMD manufacturers must keep pace with the rapidly evolving regulatory landscape and optimize their software development practices with the goal of effectively and efficiently demonstrating compliance with QMS requirements.

MAIN VIDEO TAKEAWAY

Emergency Use Authorization for SaMD Products, FDA Updates on Digital Health Initiatives, Validation Challenges for SaMD Manufacturers, and Best Practices for Leveraging Agile Methods for SaMD Development.

This presentation originally aired during the 2021 State of Medical Device Virtual Summit.

To watch more related videos, browse the full list of free replays of this song from the virtual summit event: https://youtube.com/playlist?listPLkchw-at8PkO-O70hkzdbQrzc-LtFPUbM

Additionally, you can download the slides for this presentation for free here: https://www.slideshare.net/greenlightguru/software-as-a-medical-device-samd-challenges-and-opportunities-for-2021-and-beyond

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