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Medmarc Blog (blog.medmarc.com)

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Predetermined Change Control Plans (PCCPs)

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FDA, Life Sciences Industry, AI, Machine Learning, Predetermined Change Control Plans (PCCPs)

IMDRF Posts Guidance for Predetermined Change Control Plans

September 08, 2026

The International Medical Device Regulators Forum (IMDRF) has posted a guidancefor predetermined change control plans (PCCPs), a vital document for regulatory harmonization. The scope of this IMDRF...

2 minute read
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FDA, Products Liability, AI, Medical Device, Predetermined Change Control Plans (PCCPs)

Evolving Labels and Warnings for AI-Enabled Devices: Managing Risks

October 21, 2025

When FDA finalized its guidance on Predetermined Change Control Plans (PCCPs) and, shortly after, joined Health Canada and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) in...

2 minute read
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FDA, Products Liability, AI, Medical Device, Predetermined Change Control Plans (PCCPs)

FDA Guidance on AI Medical Devices: Predetermined Change Control Plans

September 25, 2025

One of the challenges regulators face with AI-enabled medical devices is that they are not static products. Unlike a traditional implant or diagnostic tool, the device that receives FDA approval may...

2 minute read
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