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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