Health Agencies Release 5 Machine Learning-Led Device Norms

Hospital & Healthcare Management October 28, 2023
Content Team HHMGlobal

The MHRA, FDA, as well as Health Canada have jointly gone on to publish five guiding principles for machine learning-enabled medical device- MLMD manufacturers so as to develop predetermined change control plans- PCCPs.

The idea behind these guiding principles is to assist manufacturers of MLMDs by decreasing the regulatory requirements for reconsideration in case of specific modifications or improvements to their respective devices.

Building upon the 10 guiding principles for good machine learning practice, the 5 guiding principles for manufacturers of MLMD state that a properly constructed and carefully planned approach must be:

1. Bounded and focused: Describing the particular modifications that manufacturers intend to make.
2. Risk-based: The intent, design, and execution of a PCCP are guided by an approach...

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