AI in Healthcare January 12, 2021
The FDA’s new Digital Health Center of Excellence has released a document describing how it will henceforth oversee and evaluate software that incorporates AI and machine learning for medical applications.
The center, which launched in September as a part of the Center for Devices and Radiological Health (CDRH), says it will consider such incorporations as potential contributors to devices’ total lifecycle performance.
In its announcement of the plan’s release, FDA summarizes five primary actions it will now take:
1. Further developing the proposed regulatory framework, including through issuance of draft guidance on a predetermined change control plan (for software’s learning over time);
2. Supporting the development of good machine learning practices to evaluate and improve machine learning algorithms;
3. Fostering...
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