Hello Anon,
There is not a specific requirement in the regulation or submission content for Usability testing to be included/performed, though today it is more and more expected. It really depends on the type of device, how being used in Point of Care (POC) testing, the assay being used, the interface of the device, etc. It would be recommended to at least have a usability file/report which follows along with IEC 62366-1 or better to have a fully compliant usability report to the standard. FDA also has a guidance document regarding usability which is helpful to gather information related to an IVD POC device such as labelling, instructions for use, and risk management relationships to use of the device.
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 31-Jul-2023 13:53
From: Rajeswari Devanathan
Subject: IVD - Human Factors / Usability Engineering
For a 510(k) or Special 510(k) submission, the FDA expects manufacturers to provide evidence of compliance with the applicable HFE/UE standards and guidance.
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Raje Devanathan
Amerisource Bergen
TPIreg, Innomar Strategies
Senior Manager - Regulatory Affairs, Medical Devices
rdevanathan@tpireg.com
3470 Superior Court
Oakville ON L6L0C4
Canada
Original Message:
Sent: 31-Jul-2023 13:31
From: Anonymous Member
Subject: IVD - Human Factors / Usability Engineering
This message was posted by a user wishing to remain anonymous
Hi All,
Is it a requirement for a 510(k)/Special 510(k) to be submitted with Human Factors / Usability Engineering for a point of care device/instrument?<o:p></o:p>