New FDA Draft Guidance regarding Design Development of Medical Devices

The FDA has published a Draft Guidance for Industry and FDA Staff entitled "Applying Human Factors and Usability Engineering to Optimize Medical Devices Design". When finalised, this document will replace the FDA Guidance "Medical Devices Use-Safety: Incorporating Human Factors Engineering into Risk Management" (published on 18 July 2000).

The document contains 35 pages - incl. 3 annexes - and is very extensive. The goal of this guidance is to assist the medical devices industry in performing appropriate human factors testing on medical devices in order to reduce use error and injuries. The FDA hopes that the use of these recommendations will help prevent product recalls. Moreover, the guidance should also help control existing risks and reduce future ones.

The guidance provides recommendations for optimising medical device design through human factor analysis, testing and validation. The whole process of designing Medical Devices can be found under "Design Controls" in the Quality Systems Regulations (QSR) 21 CFR 820. This part of the design process - depicted as "Human Factors Validation Testing" - includes identification and analysis of use-related hazards, validation and risk analysis regarding use failures.

For further details please also see the draft guidance. Comments regarding this draft can be submitted until 19 September 2011. 

Sven Pommeranz
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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