Latest insights on FDA expectations from the 2020 Virtual HFES Health Care Symposium

EMERGO BY UL SUMMARY OF KEY POINTS:

• FDA recognizes the constraints that COVID-19 has placed on in-person testing, but emphasized the importance of seeking FDA review and confirmation before adjusting any in-person HF validation testing to be conducted remotely;
• If developing a generic or biosimilar, seek to minimize differences between it and the Reference Listed Drug (RLD) when seeking the Abbreviated New Drug Application (ANDA) pathway;
• FDA continues to focus on the need to develop a robust use-related risk analysis and ensure that use-related risk mitigations have been effectively evaluated during HF validation testing.

Last week, the Human Factors and Ergonomics Society’s first ever virtual Health Care Symposium took place. Although the symposium is a yearly occurrence, this year it took a slightly different form (i.e., online). Despite this remote format, the event still provided ample opportunity to hear the latest and greatest from fellow consultants, regulators, manufacturers, and researchers on human factors in the medical field.

FDA representatives from the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH) attended the symposium and engaged with other attendees, sharing their perspectives during workshops, panels, and presentations.

Below are some key takeaways from FDA officials’ insights and perspectives shared at the symposium:

• Seek FDA input and review when considering remote testing or other methodological changes in light of COVID-19. A frequent discussion topic and question during the conference was, unsurprisingly, how to handle human factors (HF) validation testing in light of COVID restrictions. Attendees and regulators alike agreed that there continue to be opportunities to conduct desktop-based analysis tasks and formative evaluations, albeit oftentimes now in a remote format. However, the question remains if a remote testing format will be sufficiently representative to collect accurate HF validation data. FDA representatives encouraged discussing these approaches with them directly, on a case-by-case basis. Importantly, FDA representatives emphasized that a manufacturer would be proceeding “at risk” by changing from an in-person to remote methodology without FDA buy-in, even with approval on a pre-COVID protocol pre-submission.
• FDA review timelines have not changed. The Agency representatives confirmed that they are continuing to review submissions and that their timelines have not changed during this health crisis. That said, they are prioritizing Emergency Use Authorizations (EUAs) and breakthrough devices, which do follow a more expedited timeline. On the flip side, however, future review timelines could be extended if the Agency’s review capacity is limited by the need to prioritize COVID-related submissions or inquiries. 
• For CDER, document all findings, even if they are deemed “non-critical.” As we can see in the various guidance documents, CDRH and CDER have different definitions for “critical tasks”: CDER defines such tasks as those associated with the potential for any harm, whereas CDRH defines them based on the potential for serious harm. CDER is also interested in any use-related failures that might lead to dosing or medication errors. Manufacturers should consider impacts to dosing, drug administration, or the urgency/timing of drug delivery—in other words, aspects that might lead to compromised medical care. Lastly, CDER representatives indicated they expect to see all data, even if deemed non-critical, because repeated non-critical interaction issues could indicate an issue with the device.
• Robust use-related risk analysis continues to be pivotal. Each year, the FDA provides consistent feedback regarding the importance of the use-related risk analysis. The FDA shared data describing the most frequent deficiencies among submissions; they cited that inadequate, incomplete, or inconsistent use-related risk analyses (URRAs) continue to be among the most common deficiencies. The Agency representatives reiterated the importance of conducting a thorough URRA and documenting this URRA in a clear and comprehensive manner.