Regulatory Open Forum

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  • 1.  Regulations/Guidances surrounding Beta Testing of SaMD

    Posted 24-Aug-2023 11:41

    Hello All!

    We are a standalone Medical Device Software company. We are trying to formalize our Beta Testing process. We want to look at regulations/ guidance documents/ standards surrounding Beta Testing and use that as a input. We've been looking at the IEC 62304, IEC 62366 standards, also the FDA guidance (General Principles of Software Validation, Jan 2002). Does any one know of any other resources we could possibly look at?

    Thank you,


    Aditi Kinikar
    Beachwood OH
    United States

  • 2.  RE: Regulations/Guidances surrounding Beta Testing of SaMD

    Posted 25-Aug-2023 02:30

    If the beta testing involves testing the software on actual persons then you might want to look at clinical trial / clinical investigation regulations too.

    Erik Vollebregt

  • 3.  RE: Regulations/Guidances surrounding Beta Testing of SaMD

    Posted 25-Aug-2023 04:50

    Good day Aditi,

    The concept of beta testing is not really in the medical device world.  There is verification and validation testing for software.  Beta testing would commonly be performed in a validation stage where typically the testing would still be done internal.  Erik is correct testing software with human subjects using a SaMD would need to be considered under clinical testing.  Testing of beta version in a clinical setting would generally be frowned upon by regulatory agencies unless the software has gone fully through the validation process; beta version would not be viewed in this manner.  While this may be a traditional software development term, in the medical device industry should consider more verification and validation phases with software development as described in IEC 62304.

    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs

  • 4.  RE: Regulations/Guidances surrounding Beta Testing of SaMD

    Posted 27-Aug-2023 16:58

    Hello Aditi

    You'll probably want to make a clear definition of what you mean by 'beta testing'. In the medical device context, some will assume that beta testing means something like user acceptance testing by early adopters of a released (validated, cleared, or approved) device, while others will assume it means pre-release validation testing, summative usability testing, and/or clinical evaluation of an investigational device. The requirements are very different.

    The general guidance on design control may be useful in conjunction with 62304.

    An assortment of software-related FDA guidances, some of which may be applicable:

    And a bit of background on regulatory framework for SaMD:

    Anne LeBlanc
    United States