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Integra LifeSciences has resolved the second of three warning letters it received over 15 months, announcing a closeout letter from the FDA for its Anasco, Puerto Rico, facility. Read More
Sponsors hoping to gain de novo status for new medical device accessories should prepare submissions closely mirroring those for stand-alone devices, the FDA says. Read More
Praxair, a specification developer for gas flow regulators, received a warning letter from the FDA for MDR failures following fires and other quality issues. Read More
The South Korean government has drafted a regulation that would expand its medical device tracking system to include 24 additional types of products. Read More
Integra LifeSciences has resolved the second of three warning letters it received over 15 months, announcing a closeout letter from the U.S. Food and Drug Administration for its Anasco, Puerto Rico, facility. Read More