Posted: 04 Feb 2016 10:59 AM PST
By Melisa M. Moonan –
FDA has been flooding the zone with new guidance documents. Earlier this week, FDA finalized the human factors guidance, “Applying Human Factors and Usability Engineering to Medical Devices, Guidance for Industry and Food and Drug Administration Staff” (Feb. 3, 2016). At the same time, the agency issued a complementary draft guidance, “List of Highest Priority Devices for Human Factors Review, Draft Guidance for Industry and Food and Drug Administration Staff” (Feb. 3, 2016).
We will cover the final human factors guidance is an upcoming post. In this post, we focus on the complementary draft guidance, which is intended to help with the question of when human factors data must be included in a premarket submission. Until now, it has always been something of a mystery as to when such data are required and when they are not.
The draft guidance identifies a specific list of devices for which FDA would definitely expect human factors data:
In providing the list, FDA utilized the following standard to identify the device types for which it expects submission of such human factors data: “Device types that have clear potential for serious harm resulting from use error.” FDA states that the draft list was derived by the agency from MDRs and recall information, and the list does reflect recent and historical agency concerns such as AEDs, infusion pumps, and reprocessing methods. However, there is not a detailed analysis as to how FDA applied the standard when generating the list.
Accordingly, we hope the agency will further clarify the terms “clear potential” and “serious harm” in the final guidance, particularly as they relate to established regulatory standards and definitions regarding product risk, such as those for reporting adverse events and malfunctions in the MDR regulation, 21 CFR Part 803, and for reporting recalls in the Corrections and Removals reporting regulation, 21 CFR Part 806.
Of perhaps greater concern, FDA states that additional device types may be identified in various ways, including through guidance, special controls, and classifications, as well as by individual reviewers on a case by case basis. The latter method is troubling. The welcome transparency provided by this draft guidance could be swallowed whole by case by case reviewer decisions to request human factors data for device types that are not on the list.
FDA has attempted to put guardrails around this possibility in two ways. First, the draft guidance puts the onus on manufacturers to proactively submit human factors data when their risk analysis indicates that user error (whether by failing to perform tasks, or by performing them incorrectly) could result in serious harm.
Second, the agency proposes that reviewer requests for such data could be made only if one or more of a group of factors apply. FDA lists certain factors where it states the factor also must be accompanied by a potential for serious harm resulting from use error, and other factors where it appears to presume that the potential for serious harm is inherent.
The factors where a potential for serious harm from user error must be present are:
Comments are due within 90 days from February 3rd to Docket No. FDA-2015-D-4599.