Warning Letter Roundup & Recap – Dec. 19, 2017
US FDA asks syringe-maker Nurse Assist to hire a consultant to audit its manufacturing and quality systems, and targets another firm for marketing Zika virus tests without pre-market approval or clearance in two device-related warning letters posted this week.
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In the age of coronavirus, human factors professionals are doing their best to find their way through the pandemic by putting unique twists on usability testing to see what works and what doesn’t in the new reality. That’s the topic of this week’s podcast.
Sanofi usability expert Molly Story and other longtime human factors professionals detail some extraordinary measures they’re taking to keep study participants and moderators safe, from the simple (masking up) to the more extreme (using separated testing rooms). Also: the US FDA weighs in on remote testing.
Two companies were sent FDA warning letters for selling adulterated COVID-19 tests, while a third was dinged for selling its transilluminator device for breast evaluation without agency approval or clearance.