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USFDA Med Dev: Marketing Submission Recommendations for Change Control Plan for AI/ML Enabled Device

In order to protect and promote public health, the FDA is issuing this draft guidance to further develop a regulatory approach tailored to artificial intelligence/machine learning (AI/ML)-enabled devices.


Predetermined Change Control Plans (PCCPs) are required to be included in machine learning-enabled device software functions (ML-DSF) marketing submissions. This draft guidance provides recommendations on how to include such information.


This guidance applies to device constituent parts included in combination products, including drug-device and biologic-device products.


In this draft guidance, the FDA provides recommendations on the marketing submission content for a PCCP, which generally includes:

  1. a detailed description of the specific, planned device modifications;

  2. the associated methodology to develop, validate, and implement those modifications in a manner that ensures the continued safety and effectiveness of the device across relevant patient populations, referred to as the “Modification Protocol”; and

  3. an Impact Assessment to describe the assessment of the benefits and risks of the planned modifications and risk mitigations.

Click this LINK to know more details on Policy for Predetermined Change Control Plans, with Example ML-DSF Scenarios Employing PCCPs.

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