Did you know 89% of 510(k) submissions receive FDA reviewer comments related to human factors engineering (HFE)?
Nearly 10 years ago, the US FDA released draft guidance outlining its expectations for manufacturers to apply HFE during medical device and drug-device combination product development. HFE, which is synonymous with “usability engineering,” calls for applying knowledge about users’ behavior, expectations, abilities, limitations to design to ensure safety, effectiveness, usability, and satisfaction. Of course, when it comes to medical and drug delivery products, safety is paramount.
Over the past decade, FDA’s HFE guidance has been finalized and complemented by other guidance focused on particular types of products (e.g., high-risk medical devices, drug delivery devices) or product components (e.g., labeling, software). As suggested by the pivotal guidance’s finalization and evidenced by a high percentage of FDA submissions receiving HFE-related questions and push back, the FDA is upholding their written expectations and in some cases, further raising the bar.
This presentation will introduce attendees to key FDA guidance documents on HFE and call out the key steps manufacturers must take to comply with the guidance and ensure a successful 510(k), PMA, NDA, or other submission. The presenter will share insights that go beyond the written guidance, leveraging 10 years of HFE consulting experience to call out common pitfalls and share lessons learned on how to meet FDA’s expectations and ensure your product can be used safely and effective by the intended users.
Identify FDA’s primary guidance documents related to human factors engineering and describe FDA’s key expectations described therein.
Describe the key activities required for ensuring a product can be used safely and effective by the intended users.
Apply the presenter’s insight and lessons learned beyond the guidance to avoid common pitfalls in applying HFE.