Editor's Note: A previous version of this article incorrectly stated the guidance did not apply to device constituent parts of a combination product. The US Food and Drug Administration (FDA) this ...
On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance ...
firmware and other means for software-based control of medical devices; stand-alone software applications; software intended to be operated on general-purpose computing platforms; dedicated ...
The US Food and Drug Administration (FDA) has released draft guidance for sponsors outlining its thinking about the documentation needed to support the agency’s evaluation of device software functions ...
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