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Five Tips to Make the Most of Your Human Factors Validation Protocol Pre-Sub to the US FDA

How medical device and drug companies can take full advantage of presubmission consultations with the US Food and Drug Administration regarding HF validation test protocol reviews.

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November 30, 2021

The US Food and Drug Administration (FDA) strongly encourages medical device and pharmaceutical manufacturers (“Sponsors”) to pre-submit human factors (HF) validation test protocols for review prior to test conduct. FDA takes this stance because they want to actively partner with and support industry and verify that the HF validation tests conducted--and the resulting data and report--reflect the rigor and quality needed to support regulatory clearance or approval. FDA’s review could take 60 to 90 days or more, depending on the agency’s workload and priorities.

If you’re investing the time in submitting a “pre-sub” and seeking and waiting for FDA’s feedback (which we highly recommend), the steps below can help you obtain the most actionable and valuable FDA feedback.

  1. Submit a full HF validation protocol. FDA has clarified in industry presentations and in correspondence with sponsors that it will only review and provide feedback on a full protocol, rather than a synopsis or other test method summary. The protocol should include an overview of the product and its user interface, as well as the product’s intended users and use environments. Stemming from the intended user discussion, you should specify and justify how many and what type of participants you will include in your test, all of whom should represent product users. The protocol should also outline all critical tasks associated with product use (excerpted from the use-related risk analysis), use scenarios and knowledge tasks that you will use to rigorously evaluate any critical tasks and associated risk mitigations, and specific task success/fail criteria. Last but certainly not least, the protocol should include the moderator’s script and the questions you will ask to collect participants’ subjective feedback regarding the root causes of any use errors and other use issues.
  2. Submit your use-related risk analysis and key HF background information. An HF validation protocol describes the core test method on which you are seeking FDA’s feedback, but it can’t be reviewed in a vacuum. FDA needs sufficient context to understand your product and its user interface, including the use-related risks, identified known use problems and the HF work you have done throughout its development to refine and ideally optimize the user interface for product users. We recommend submitting a protocol along with a complete draft of Sections 2-7 of the HFE report outlined in Appendix A of FDA’s final HF guidance. Companies developing medical devices (typically to be reviewed by the FDA Center for Devices and Radiological Health, or CDRH) and drug-device combination products (typically reviewed by the FDA Center for Drug Evaluation and Research, or CDER) can both follow this outline, though combination product manufacturers would be equally well-served to follow the outline provided in Section IV B of its draft guidance on complete submissions.
  3. Provide product labeling and product samples. In all cases, provide the labeling, including but not limited to on-product labels, packaging and instructions for use, that you plan to test in your HF validation test and subsequently bring to market. When feasible, and especially when seeking FDA’s feedback on an HF validation protocol intended to validate a drug-device combination product, submit five product samples along with your documentation (see Section IV B, point 4 in the FDA guidance on complete submissions). The samples should match those you intend to evaluate in the HF validation test, including the representative packaging and labeling. If you are submitting your protocol for review well ahead of when such samples will be available--kudos to your advanced planning--clarify this in your pre-submission documents and provide the most representative samples possible.
  4. Ask three to five clear, specific questions. In addition to the 100+ pages of documentation you are likely to submit, as well as perhaps product samples, it’s helpful to include specific questions to help ensure FDA focuses and comments on HF topics critical to help you scope and execute the upcoming test. Appendix 2 of FDA’s Q-submissions guidance document provides sample pre-sub questions for various topics, including HF. The HF section includes questions that aim to confirm the adequacy of your use-related risk analysis and critical task identification efforts, as well as your test participant sampling plan, both of which are on our “go to” list. We also often include questions related to the participant training plan (if product users will receive training prior to independent use) and seek explicit feedback on any proposals to conduct remote versus in-person testing, if applicable. We typically submit three to five specific questions with an HF validation test pre-sub, though we’re unaware of any specific guidance or limits regarding the number of questions.
  5. Clearly indicate your pre-sub is focused on or includes HF documentation. Last but of course not least, you want to help ensure that your protocol and supplemental documentation is reviewed by someone specializing in HF, rather than another agency representative who might typically focus on clinical or other domains. While the HF reviewers usually do get involved (thankfully and logically), there have been some situations in which it seems as though FDA feedback on the proposed test method might not have come from one of the agency’s HF reviewers, but rather another representative. It’s critical to call out the need for a review by FDA’s relevant HF team in your pre-sub cover letter; the cover letter should top out at two or three pages in length to help FDA focus on the key objective(s) of your pre-sub. When submitting to CDER, you should check the appropriate box on FDA form 1571 (“Human Factors Protocol”) or 356h (“Human factors information”), depending on your submission type, to ensure your protocol gets routed to HF personnel. The equivalent form for CDRH, form 3514 (which only opens in Internet Explorer), does not have a dedicated HF option. However, you could note the HF focus of the pre-sub on this form under Section H3, “Other.”

If you’re considering seeking third-party support for developing or fine-tuning your HF FDA pre-sub documentation and/or associated questions, be sure to engage a partner who is experienced and familiar with the nuances of these critical communications.

Allison Strochlic is Research Director at Emergo by UL’s Human Factors Research & Design division.

Additional human factors engineering (HFE) and usability resources:

  • Human factors design and prototype development support
  • HFE user research for medical devices, IVDs and combination products

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