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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
Respironics California, a Philips subsidiary, received an FDA warning letter for medical device reporting failures, including one related to a life-sustaining/life-supporting device. Read More
MedOne Surgical, a Sarasota, Fla., devicemaker, received an FDA Form 483 for failures related to complaint records, in-process acceptance and other procedures. Read More
House and Senate lawmakers are teaming up on an overhaul of FDA device procedures, including expanding the use of third-party quality audits. Read More