Warning Letter Close-Outs – April 2022
The US FDA issued four close-out letters last month. Three resolved warning letters that had been issued to duodenoscope manufacturers about problems with Sec. 522 postmarket studies.
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News We’re Watching: Expiring Guidance Documents; Multi-Cancer Diagnostic Meeting Set; 510(k)s For BD And Smileyscope
This week, the US FDA announced that several pandemic-era guidance documents are no longer in effect; an FDA advisory committee meeting on multi-cancer detection (MCD) diagnostics was scheduled; and both a needle-free blood collection device and the first VR treatment for pain and anxiety landed FDA clearances.
Test is among first of a wave of products initially authorized for emergency use by FDA now pursuing traditional approval pathways to stay on market.