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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 Utopia Group, a specification developer for an umbilical cord clamp and cutter, received an FDA warning letter for making product changes without following regulations and for lacking a host of procedures. Read More
Malaysia’s Medical Device Authority has released a 12-step guideline for submitting registration applications for in vitro diagnostic products through the agency’s web-based system. Read More
A Federal Trade Commission report on data brokers suggests that devicemakers should take extra steps to protect personally sensitive information, one attorney says. That includes incorporating data protection clauses into third-party contracts. 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