Q&A Guidance Document Discusses Laser Product How-Tos
Products like laser pointers, gun sights and lasers used to align machinery fall under a new guidance document from the US FDA, which details the limits on how much radiation these products may emit.
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The US FDA’s decision to allow Medtronic to market the Symplicity Spyral renal denervation (RDN) device sets up a rivalry in the RDN market, as the medtech giant’s offering will come up against ReCor’s Paradise system.
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This week, the US FDA announced that several pandemic-era guidance documents are no longer in effect; an FDA advisory committee meeting on multi-cancer detection (MCD) diagnostics was scheduled; and both a needle-free blood collection device and the first VR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.