Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in BioWorld, in “FDA’s Human Factors Draft Draws Fire for Introduction of ‘Critical Task’ Concept,” by Mark McCarty. (Read the full version – subscription required.)
Following is an excerpt:
The U.S. FDA’s December 2022 draft guidance for human factors (HF) information in medical device premarket filings is a complete do-over of a previous draft guidance from 2016, but the reaction from industry has been anything but cheerful. Several observers, including the Medical Device Manufacturers Association (MDMA), hammered the new draft guidance for its introduction of the concept of a critical task due to the expansive effect that would have on the need for human factors studies for medical devices. …
Writing for the Combination Products Coalition (CPC), Brad Thompson of Epstein, Becker & Green P.C. said the draft guidance's definition of a critical task was not well aligned with an HF guidance from the FDA's Center for Drug Evaluation and Research …
