FDA WARNING_LETTER - Fujifilm Corporation

On March 9, 2018, the FDA issued a Warning Letter to Fujifilm Medical Systems U.S.A., Inc. for non-compliance with Section 522 of the Federal Food, Drug and Cosmetic Act and 21 CFR Part 822. The letter concerns the firm's failure to conduct postmarket surveillance on duodenoscope model ED-530XT, as ordered by FDA on October 5, 2015 (522 Order PS150002). This order was issued due to the risk of infection and death from device failure, constituting "serious adverse health consequences."

The 522 Order required two studies: a Human Factor Study and a Sampling and Culturing Study, to assess reprocessing effectiveness and contamination. While the Human Factors Study is progressing as expected, the Sampling and Culturing Study is significantly behind schedule. The firm was required to commence data collection for Phase 2 within 15 months of the order. However, as of January 16, 2018, only 17 of the required 85 samples for Phase 1 had been collected and analyzed from two sites, instead of the 85 samples from 1-3 sites by February 2017.

This failure to comply constitutes a prohibited act under Section 301(q)(1)(C) of the Act, rendering the duodenoscope model