Hi All,
The FDA just published Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations Draft.
This draft guidance document provides recommendations regarding the contents of marketing submissions for devices that include artificial intelligence (AI)-enabled device software functions including documentation and information that will support FDA's evaluation of safety and effectiveness. The recommendations reflect a comprehensive approach to the management of risk throughout the device total product life cycle (TPLC). To support the development of appropriate documentation for FDA's assessment of the device, this draft guidance also proposes recommendations for the design, development, and implementation of AI-enabled devices that manufacturers may wish to consider using throughout the TPLC.
You should submit comments and suggestions regarding this draft document within 90 days of 16 publication in the Federal Register of the notice announcing the availability of the draft 17 guidance. Submit electronic comments to https://www.regulations.gov. Submit written 18 comments to the Dockets Management Staff, Food and Drug Administration, 5630 Fishers Lane, 19 Room 1061, (HFA-305), Rockville, MD 20852-1740. Identify all comments with the docket 20 number listed in the notice of availability that publishes in the Federal Register.
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Michael Roza CPA, CISA, CIA, CC, CCSKv5, CCZTv1, MBA, EMBA, CSA
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