- Ensure training is representative of real-world intended use. As described in FDA’s CDRH final HFE guidance, training provided during HF validation testing should be as representative as possible to the intended training for real-world use. As such, if there are no controls in place to ensure training is provided during actual use, then it might be appropriate to exclude training for participants during an HF validation test. Relatedly, participants should not be artificially encouraged to self-train if they might not do so during actual use. Instead of providing time for them to “familiarize” themselves with the product, they should instead be provided with the product and left to take whatever steps they might normally take (which may or may not include independent familiarization before beginning a task). As always, if there is uncertainty regarding how to replicate intended training during an HF validation test, seek FDA’s review and confirmation on the proposed method before proceeding.
- Seek to minimize UI differences when developing a generic or biosimilar. CDER representatives dove into the details of one of their draft guidance documents, Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA. Most notably, despite industry’s strong desire to focus on product improvements, the Agency emphasized the importance of seeking to minimize user interface differences between the RLD and the proposed generic/biosimilar, even if modifications would optimize the design. The reason for this is that an ANDA approval relies on the Agency’s assessment of “sameness” with regard to the safety and efficacy of the RLD vs. the proposed new product. If choosing to follow the ANDA path, in the words of the Agency, they approve “biosimilars, not biobetters.”
- Consult the FDA before proceeding with a Comparative Use Human Factors Study. When pursuing an ANDA pathway, if your threshold analysis identifies “other differences” that might indicate the need for additional HF data, consult with the Agency prior to conducting a Comparative Use Human Factors (CUHF) study. This is to ensure that methodological decisions (e.g., sample size, study design, appropriate delta) are in line with their expectations. Notably, CDER also mentioned that consulting with the FDA might reveal that a CUHF study is not needed, despite identifying “other differences” during the threshold analysis.
As always, FDA representatives encouraged manufacturers to contact them or the FDA project manager via appropriate channels with any questions or to get input on a specific situation.
Watch the webinar for more human factors insights
Emergo by UL’s Human Factors Research & Design (HFR&D) team will be presenting a webinar on June 3, 2020 titled “Combination products: Common use errors and design considerations,” which will further explore some of these topics.
Laura Birmingham and Rachel Aronchick are both Managing Human Factors Specialists in Emergo by UL’s HFR&D division.
Additional HFE and usability resources from Emergo by UL:
- COVID-19 regulatory resource center
- Human factors engineering (HFE) research support for medical devices and IVDs
- Medical device and product evaluation support
- US FDA Pre-Sub (Q-Sub) consulting for medical device manufacturers
- Webinar: Meeting FDA expectations for HFE activities