Details on the FDA new draft Guidance, "Content of Human Factors Information in Medical Device Marketing Submissions."
On December 9th the FDA released a new draft Guidance, Content of Human Factors Information in Medical Device Marketing Submissions. The draft guidance can be accessed here: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-human-factors-information-medical-device-marketing-submissions
The new guidance takes a risk-based approach to determining the required amount of HF Data for a submission. In some instances, this will reduce the amount of HF Data required for modified devices.
Summary of Key Points:
After finalization, this guidance will supersede the draft guidance “List of Highest Priority Devices of Human Factors Review.”
Upon finalization of the new draft guidance, FDA intends to concurrently revise “Applying Human Factors and Usability Engineering to Medical Devices” to:
o incorporate the definitions from the new guidance
o replace Section 9 “Documentation”
o replace Appendix A “Human Factors and Usability Engineering Report”
The requirements for the HF Data to include in the submission are based on the HF Submission Category. The new guidance provides three Human Factors (HF) Submission Categories:
o Submission Category 1: Modified devices in which there are NO changes to the UI, intended users, intended uses, intended use environments, training and labelling.
o Submission Category 2: New devices with no critical tasks or modified devices in which there were changes to one or more of the following: UI, intended users, intended uses, intended use environments, training and labelling but there are NO new critical tasks introduced and/or NO change that impacts critical tasks.
o Submission Category 3: New devices with critical tasks or modified devices with new critical tasks introduced or existing critical tasks impacted by changes.
The new guidance provides the following table:
