FDA Draft PriorityDevices for Human Factors Review

FDA issued a draft guidance entitled “`List of Highest Priority Devices for Human Factors Review.” FDA is issuing this draft guidance document in order to inform medical device manufacturers which device types should have human factors data included in premarket submissions. For device types listed the guidance suggests that information indicated in the new Final HFE/UE guidance be included in the premarket submissions or should provide a detailed rationale that supports the conclusion that human factors data are not necessary. The guiidance also indicates FDA may recommend or require human factors data be included in premarket submissions through other guidance or on a case-by-case request basis by reviewers. It is interesting that the list of device types in this guidance does not include all high risk devices and no radiation emitting or radiation therapy devices are included. The full guidance is at the link provided.

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