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Manufacturers of ultraviolent sunlamps used in tanning beds have 450 days to submit 510(k)s on lamps now in use, an FDA final reclassification order on the preamendment devices says. Makers of new sunlamp products must begin submitting premarket notifications within 90 days. Read More
The FDA is classifying pancreatic drainage stent and delivery systems as Class II with special controls, but will still require premarket notification before distribution. Read More
Devicemakers will be able to submit traditional 510(k)s electronically to two branches in the U.S. Food and Drug Administration’s Center for Devices and Radiological Health, under an experimental program announced May 1. Read More