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INDUSTRY NEWS BRIEF: New Draft Guidance on Content of Human Factors in Medical Device Marketing Submissions


Applying cGMPs for Combination Products to Ophthalmic Devices

The FDA recently published new draft guidance regarding Content of Human Factors Information in Medical Device Marketing Submissions. While this, technically, only applies to medical device submissions (510(k), de novo, PMA) and not drug/biologic-led combination products (subject to its own draft guidance, which has a revision currently underway), it does contain relevant information and useful approaches for Human Factors regardless of product type (and notably included OCP during development, but not CDER/CBER).

This guidance is intended to accompany the existing device HF guidance, though some content, including definitions, will be updated to align with those contained herein. Additionally, this guidance is intended to replace the previously issued draft List of Highest Priority Devices for Human Factors Review, which took a more prescriptive approach to the devices requiring HF content. Instead, the new guidance provides a more generalizable process flow that can be applied to all devices (and, notably, a useful approach to handle changes in existing devices) and relies upon the identification and evaluation of critical tasks. It then provides 3 buckets of HF submission categories ranging from the least to most rigorous levels of HF data requirements.

If you are interested in learning how you can apply this new draft guidance to improve your combination product’s Human Factors activities, complete the contact form on our website HERE and we can schedule a call.


Jonathan Amaya-Hodges, Director, Technical Services, Suttons Creek, Inc. – Jonathan has over 16 years of multidisciplinary experience in regulated medical products (drugs, biologics, medical devices, and combination products) at multiple global companies. He has practical experience in Development/Engineering, Quality Assurance, and Regulatory Affairs for various types of combination products with a focus on drug delivery. Additional background includes digital health (including smart packaging/connected devices and software as a medical device, or SaMD) and in vitro diagnostics, along with clinical development (bridging) and lifecycle management for combination products. Jonathan engages with the global combination product community by speaking at conferences, lecturing in courses, serving key roles within prominent industry organizations, and interfacing with regulators on a variety of topics.