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. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/design-control-guidance-medical-device-manufacturers
An assortment of software-related FDA guidances, some of which may be applicable: https://www.fda.gov/medical-devices/digital-health-center-excellence/guidances-digital-health-content
And a bit of background on regulatory framework for SaMD: https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd
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Anne LeBlanc
United States
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Original Message:
Sent: 25-Aug-2023 04:50
From: Richard Vincins
Subject: Regulations/Guidances surrounding Beta Testing of SaMD
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.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 25-Aug-2023 02:29
From: Erik Vollebregt
Subject: Regulations/Guidances surrounding Beta Testing of SaMD
If the beta testing involves testing the software on actual persons then you might want to look at clinical trial / clinical investigation regulations too.
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Erik Vollebregt
Partner
Amsterdam
Netherlands
Original Message:
Sent: 24-Aug-2023 11:40
From: Aditi Kinikar
Subject: Regulations/Guidances surrounding Beta Testing of SaMD
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
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Aditi Kinikar
Beachwood OH
United States
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