AI/ML Good Machine Learning Practices

A new draft guidance was issued by Artificial Intelligence/Machine Learning-enabled Working Group, with comments welcomed until Friday 30th August.

There is a comments template on the website to provide the comments and they must be emailed to: imdrf-aiwg@fda.hhs.gov.

• • Title of draft guidance: Good machine learning practice for medical device development: Guiding principles
  • Authoring group: Artificial Intelligence/Machine Learning -enabled Working Group

What is the purpose of the AI/ML Good Machine Learning Practice draft guidance?

The draft guidance is proposed to promote the development of safe and effective AI/ML medical devices, and it is important to maintain alignment with Software as a Medical Device (SaMD). This new document will present 10 guiding principles to encourage collaboration of other international standards organizations to create regulatory policies and guidelines.

Good machine learning practices (GMLP) should keep up with the fast-evolving AI medical device developments and creating more guidance in this field will strengthen international standards. You can read more about the IMDRF’s update here.

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If you would like to discuss or need help understanding the new draft guidance document for AI/ML good machine learning practices, contact us so we can assist you. 

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