FDA Publishes Draft Guidance on AI Updates

A new draft guidance by the US Food and Drug Administration (FDA) would allow developers of artificial intelligence (AI) and machine learning (ML) digital health solutions to make changes to their products without submitting a new application. The plan would let submissions include predetermined change control plans (PCCP) that would lay out how developers would ensure changes are safe and effective.

According to Ferdous Al-Farique, “While the agency has already allowed more than 500 AI/ML products on the market, many of which already allow PCCP, Congress passed legislation as part of the 2023 Consolidated Appropriations Act that gave FDA explicit authority to approve PCCPs as part of AI/ML product applications.”

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(Source: Regulatory Focus, March 31^st, 2023)