IEC TR 62366 Usability Engineering Guidance

A committee draft (CD) of “IEC TR 62366-2: Medical devices – Part 2: Guidance on the application of usability engineering to medical devices” was issued for comment. This technical report provides medical device manufacturers with guidance on how to integrate usability engineering (also called human factors engineering) principles and user interface design practices into their overall medical device development processes. It focuses not only on usability as it relates to safety, but also on how usability relates to attributes such as task accuracy, completeness and efficiency, and user satisfaction. This is a companion document to IEC 62366-1, which is currently out for final (FDIS) ballot.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:

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