Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Part Two
0
By
In Healthcare Law
Posted

Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) – Part Two

Key provisions of the FDA’s proposed regulatory framework of software that uses and adapts to artificial intelligence and machine learning

READ MORE
 Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD)
0
By
In Healthcare Law
Posted

Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD)

The FDA has a new proposal for approving AI and ML software that looks at the total product lifecycle from development to post-market uses and the adaptations the software learns

READ MORE
 FDA Policy on When Software that Uses Artificial Intelligence and Machine Learning qualifies as a Medical Device
0
By
In Healthcare Law
Posted

FDA Policy on When Software that Uses Artificial Intelligence and Machine Learning qualifies as a Medical Device

As more artificial intelligence products become available, the FDA is reevaluating its approval criteria. For now, De novo approval and 501(k) are being used along with premarket approval.

READ MORE
 A Benevolent Artificial Intelligence Will Usher In Utopia
0
By
In Business Law, FDA & FTC Law, Healthcare Law
Posted

A Benevolent Artificial Intelligence Will Usher In Utopia

A benevolent AI (artificial intelligence) could usher in utopia... but will augmented intelligence destroy it?

READ MORE