Emergo Group’s Human Elements Analysis & Design staff takes a more in-depth take a look at new FDA HFE steering for medical gadgets.

Emilee Stanczyk, Emergo Group

The FDA issued a brand new draft HFE steering doc, Content material of Human Elements Info in Medical System Advertising Submissions, on Dec. 9, 2022. The steering goals to assist medical system producers decide what analysis info ought to be included in advertising and marketing submissions for medical gadgets. This submit summarizes the steering and describes the submission classes and analysis info wanted for every class.

The brand new steering is meant to enhance the FDA’s ultimate HFE steering from 2016, Applying Human Elements and Usability Engineering to Medical Units. The brand new steering outlines what analysis info to incorporate in a advertising and marketing submission, as famous above, however doesn’t describe how you can carry out a human elements analysis; that is the place the 2016 draft steering stays significantly related.

Figuring out the submission class and analysis info to submit

The draft steering doc accommodates a flowchart that producers can use to find out which of the three outlined classes their advertising and marketing submission matches into based mostly on solutions to the next questions:

1. Is the submission a modification to an present system?
2. (If a modified system) Are there any adjustments to the consumer interface, supposed customers, makes use of, or use environments, coaching, or labeling?
3. Based mostly on the use-related threat evaluation (URRA), are there any vital duties current (if a brand new system), or have any new vital duties been launched or any present vital duties been impacted (for a modified system)?

Under, we describe the three submission classes and, for each, share a fast instance and listing the required analysis info.

• Class 1 is for modifications made to an present system, however no adjustments to the consumer interface, supposed customers, makes use of, or use environments, coaching, or labeling. For instance, upgraded cybersecurity options that don’t affect the consumer interface. Class 1 submissions ought to embody an announcement that explains why the system modifications don’t “have an effect on the human elements concerns of the modified system,” leveraging earlier evaluations to supply a conclusion and high-level abstract.
• Class 2 is for brand spanking new gadgets that would not have any vital duties or modifications made to an present system (together with adjustments to the consumer interface, supposed customers, makes use of, or use environments, coaching, or labeling) that don’t add or affect vital duties. For instance, labeling adjustments that don’t have an effect on any vital duties. Class 2 submissions ought to embody a rationale for why there are not any vital duties (for brand spanking new gadgets) or why no vital duties are added or impacted (for modified gadgets). For all Class 2 submissions, HFE report sections 1-4 are anticipated to be submitted as nicely (extra on this under).
• Class 3 is for brand spanking new gadgets with vital duties or modifications to an present system (together with adjustments to the consumer interface, supposed customers, makes use of, or use environments, coaching, or labeling) that add or affect vital duties. For instance, the addition of a brand new consumer group who is predicted to carry out vital duties. Class 3 submissions ought to embody a complete HFE report (sections 1-8) that features HF validation take a look at outcomes and addresses all vital duties (for brand spanking new gadgets) or new or impacted vital duties (for modified gadgets). If any vital duties had been impacted (for modified gadgets), however present threat management measures stay acceptable, present that rationale within the submission.

We advise that any producer going by the advertising and marketing submission pathway first search the FDA’s “buy-in” on the chosen submission class.

Study extra about new and up to date HFE report content material from the FDA and adopting the brand new draft steering on the Emergo Group’s weblog.

Emilee Stanczyk is managing human elements specialist at Emergo by UL’s Human Elements Analysis & Design (HFR&D) division.

The opinions expressed on this weblog submit are the writer’s solely and don’t essentially replicate these of Medical Design and Outsourcing or its staff.