Dive Brief:

• A medtech trade group has warned the U.S. Food and Drug Administration (FDA) that its draft guidance on human factors (HF) information in medical device submissions is “too expansive.”
• The Medical Device Manufacturers Association (MDMA) told the FDA that parts of the guidance “inappropriately depart” from a risk-based approach and will strain the agency’s resources.  
• Other groups gave a warmer welcome to the proposals, with AdvaMed suggesting specific edits to make the FDA’s recommendations simpler and clearer without criticizing the overall approach.

Dive Insight:

HF engineering is the use of knowledge about human behavior and abilities to ensure the usability of devices. Late last year, the FDA shared draft recommendations about the HF and usability engineering information that applicants should include in marketing submissions. 

Industry feedback on the draft is now available. MDMA took one of the hardest lines on the FDA’s draft in comments that warn HF validation testing “may be required without regard for considerations relevant to a risk-based approach” and that data may be needed for modified devices regardless of whether the manufacturer “could otherwise demonstrate that existing controls mitigate the risk.”

As such, the trade group is concerned the guidance “would implicate a broad number of device types which may be well-understood and have long histories of safe and effective marketing.” MDMA said a manufacturer of a surgical mask that is a “new device” would need to submit HF validation testing data.

The trade group submitted a second piece of feedback that raised specific concerns about the impact of the draft on robot-assisted surgical devices. MDMA told the agency that simulated HF testing is viewed as best practice in the sector because actual use testing “can be impractical and in some cases unsafe.”

Other organizations raised fewer fundamental problems with the draft. AdvaMed agreed “with the need for clarity in the expectations for human factors content in premarket marketing submissions” and only requested specific changes. The trade group wants the FDA to offer a one-year transition period, rather than the 60 days proposed in the draft, and requested the addition of a statement that HF content may be unnecessary for some devices, but its feedback lacks the overarching criticisms raised by MDMA.

The FDA also received feedback from drug and device companies. ZimVie requested the rewording of a definition, and Surmodics proposed changes to align the guidance with the least burdensome principle. The interest of drugmakers in the draft reflects the question of how it applies to combination products. Merck & Co. suggested adding a statement about the applicability of the draft to combination products, and a trade group proposed the FDA’s “well-considered” framework be adopted for all combinations.