Software & SaMD

Most AI medical device companies misunderstand PCCPs

March 13, 2026

By Dr. Ebot Eyong

A Predetermined Change Control Plan (PCCP) is not regulatory flexibility. It is a pre-authorized change under strict control. This article explains why PCCPs require clear change definitions, statistical thresholds, bias monitoring, drift detection, rollback procedures, and documented impact assessments.

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Partner With Dr. Eyong

A Predetermined Change Control Plan (PCCP) is not regulatory flexibility.

It is a pre-authorized change under strict control.

As FDA scrutiny increases.

Here’s what leaders need to know:

A PCCP must clearly define which changes are allowed
Statistical performance thresholds must be predefined
Bias monitoring cannot be optional
Drift detection must be built into governance
Rollback procedures are mandatory
Impact assessments must be documented for every update

If your PCCP is vague, FDA will issue deficiencies.

If your PCCP is overly narrow, you gain no flexibility.

The balance requires:

AI governance maturity
ISO 14971 integration
Strong statistical design
Regulatory foresight
Cross-functional execution

Done correctly, a PCCP becomes a competitive advantage.

Done poorly, it increases regulatory risk.

AI innovation without a structured regulatory architecture is exposed.

At E&E Medicals & Consulting, we help manufacturers design FDA-ready PCCPs that scale globally and align with EU AI Act and MDR expectations.

If you're building AI-enabled devices, governance isn’t optional - it’s strategic.

— Dr. Ebot Eyong
Global AI Regulatory Strategy

For more information, visit https://eemedicals.com/

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Continue exploring Dr. Ebot Eyong’s professional insights on healthcare regulation, FDA submissions, AI-enabled medical devices, quality systems, and global compliance strategy.

AI & Digital Health

FDA Expands Digital Health Exemptions: Implications for AI-Enabled Medical Devices

December 18, 2025

By Dr. Ebot Eyong

FDA’s revised digital health guidance expands exemptions for certain low-risk digital health products from active regulatory oversight. This article explains how wearables, wellness products, clinical decision support tools, and AI-enabled software may be affected by the updated risk-based approach.

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Cybersecurity & Cloud Systems

Cloud-Based Systems for Medical Devices: FDA Perspective

April 22, 2024

By Dr. Ebot Eyong

The FDA advocates adopting cloud-based systems for medical devices, highlighting benefits such as scalability, enhanced security, collaboration, innovation potential, and operational cost savings. This article explains FDA perspectives and best practices for cloud-based medical device systems.

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CMC & FDA Submissions

Why is Module 3 (CMC) in FDA's New Drug Application (NDA) submission always challenging?

May 23, 2025

By Dr. Ebot Eyong

Despite thorough engagement with agencies such as the FDA, companies continue to face CMC and analytical issues that lead to Complete Response Letters. These issues often arise late, exposing gaps between sponsor expectations and FDA standards, especially in assay reproducibility, validation, and tech transfer.

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EU Regulatory Strategy

EU Proposal to Revise MDR and IVDR: Implications for Innovation, Documentation, and Software Oversight

February 17, 2026

By Dr. Ebot Eyong

The European Commission has proposed a targeted revision of the Medical Device Regulation and In Vitro Diagnostic Regulation aimed at supporting innovation while reducing unnecessary administrative burden. This article explores the impact on technical documentation, manufacturers, implementation challenges, and software oversight.

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