Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions; Guidance for Industry and Food and Drug Administration Staff; Availability
FDA released guidance on marketing submissions for Predetermined Change Control Plans (PCCPs) for AI-enabled medical device software, outlining recommended content and format.
Aforeworn detected this change in the Healthcare AI Regulation (FDA / ONC) space on July 29, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated Medium urgency. Medical device companies, health tech startups, and digital health compliance teams developing AI/ML-enabled SaMD that may require FDA marketing authorization. should confirm how it applies to their specific situation before acting. There is a time constraint attached: No specific deadline; guidance is effective immediately upon publication (December 4, 2024).. Acting after that point can mean penalties, a lapsed licence, or lost eligibility — exactly the kind of surprise Aforeworn exists to prevent. Aforeworn monitors Healthcare AI Regulation (FDA / ONC) continuously and turns every detected change into a plain-English briefing like this one, so you always know first. Forewarned is forearmed.
What changed
FDA published final guidance detailing recommendations for PCCP submissions, including what information to include, how to describe planned modifications, and documentation standards.
Who it affects
Medical device companies, health tech startups, and digital health compliance teams developing AI/ML-enabled SaMD that may require FDA marketing authorization.
What you must do
Review the guidance to align PCCP development and submission strategies with FDA recommendations; update existing PCCP documentation if needed.
Deadline
No specific deadline; guidance is effective immediately upon publication (December 4, 2024).
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