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Devicemakers seeking to register products in South Korea say new regulations requiring them to first obtain a Korean good manufacturing practice certificate could delay product launches. Read More
The China Food and Drug Administration plans to beef up its inspections system for medical devicemakers by adding more investigators and improving the performance of quality testing centers. Read More
Customed, a Puerto Rican maker of convenience packs for surgical procedures, received a U.S. FDA warning letter for unacceptable warehouse conditions and other GMP issues. Read More
The U.S. FDA has chosen a veteran public health officer to spearhead its device postmarket surveillance programs. Gregory Pappas joined the agency in February as associate director for national device surveillance in the Center for Devices and Radiological Health’s Office of Surveillance and Biometrics. Read More
The U.S. FDA will roll out a simplified adverse event reporting form this spring in hopes of getting more consumers to use its MedWatch system, agency officials said Feb. 4. Read More
U.S. industry group AdvaMed is working with regulators around the world to ensure a global approach to unique device identification — to avoid scenarios where different countries’ UDI systems can’t communicate with one another. 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