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 FDA also issued a draft list of devices that will always be subject to human factors review along with another draft guidance on applying human factors engineering to combination products.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: