PRE-RECORDED WEBINAR: Human Factors – FDA’s New and Renewed Expectations Next

PRE-RECORDED WEBINAR: Human Factors – FDA’s New and Renewed Expectations

By Michael Wiklund

Time To Read Less than a minute

In March 2016, FDA published final guidance on applying HFE to medical devices. FDA also issued a draft list of devices that will always be subject to human factors review along with another draft guidance on applying human factors engineering to combination products.

This hour-long pre-recorded webinar, delivered by co-author of HE-75, Michael Wiklund and Allison Strochlic discusses these changes, the impact to the industry and individual manufacturers. It also includes questions posed by participants during the live event, in March 2016.

Key takeaways from this webinar include:

  • Critical task is the “term of the year” – a use step where a UE or other interaction issue could lead to serious patient or user harm.
  • Need to perform rigorous use-related risk analysis per CDER and CDRH. This serves as the basis for identifying critical tasks, and also determining whether HF data needs to be submitted (along with the high priority doc)
  • Key is when to submit HFE data; the QSR still calls for HFE (validation activities, in particular) and FDA still expects manufacturers to apply HFE during device development as part of a robust design and development process
  • FDA repeatedly encourages manufacturers to submit HF validation test plans for review and seek input on the scope of HF work to be conducted; take them up on the offer, but plan accordingly (up to 3 months review time).

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