Regulatory Open Forum

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Hi all,

Are there any regulatory guidelines about how the likes of the FDA define Major vs Minor changes to a SaMD? Or is this left to each manufacturer to define? 

In the IMDRF UDI Guidance (IMDRF/UDI WG/N7FINAL:2013), Major and Minor changes are described as:

Major SaMD revisions are meant as complex or significant changes affecting
1) the orPostiginal performance and effectiveness,
2) the safety or the intended use of the SaMD,
These changes may include new or modified algorithms, database structures, operating platform, architecture or new user interfaces or new channels for interoperability.

Minor SaMD revisions are generally associated with bug fixes, usability enhancements (not for safety purpose), security patches or  operating efficiency

Thanks!