Predetermined Change Control Plans for Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
FDA releases draft guidance on Predetermined Change Control Plans (PCCPs) for AI/ML-enabled medical devices, outlining a framework for manufacturers to plan and document future modifications without needing new premarket submissions.
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 manufacturers, health tech startups, and digital health compliance teams developing AI/ML-based SaMD or predictive models. should confirm how it applies to their specific situation before acting. There is a time constraint attached: Comments on the draft guidance are due by November 20, 2024 (90 days after publication).. 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FDA introduces draft guidance on PCCPs, allowing manufacturers to describe planned changes (e.g., algorithm updates) in advance, potentially reducing the need for separate 510(k) submissions for each modification.
Who it affects
Medical device manufacturers, health tech startups, and digital health compliance teams developing AI/ML-based SaMD or predictive models.
What you must do
Review the draft guidance to understand PCCP requirements and consider how to incorporate them into your device development and regulatory strategy.
Deadline
Comments on the draft guidance are due by November 20, 2024 (90 days after publication).
Never miss a change like this again
Aforeworn watches Healthcare AI Regulation (FDA / ONC) around the clock and alerts you the moment a rule moves — with a plain-English brief on what to do.
Start your free trialRelated changes in Healthcare AI Regulation (FDA / ONC)
- Medical Devices; General Hospital and Personal Use Devices; Classification of the Diabetes Digital Behavioral Therapeutic Device
- HIPAA Security Rule To Strengthen the Cybersecurity of Electronic Protected Health Information
- Health Data, Technology, and Interoperability: ASTP/ONC Deregulatory Actions To Unleash Prosperity
- Nondiscrimination in Health Programs and Activities
- Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing