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The FDA is seeking input from stakeholders on potential solutions to address the scientific and regulatory challenges for a certain type of point of care in vitro diagnostic that monitors warfarin. Read More
China’s FDA has unveiled plans to assemble an expert committee to review and discuss medical device classification, as well as spelling out the rules for using generic names for devices. Read More
Devicemakers should submit a letter of intent to the European Medicines Agency at least six months in advance before they plan to seek an initial consultation on an ancillary medical substance or ancillary human blood derivative incorporated in a device, according to a new question & answer guidance. Read More
Negotiations continue to move forward for the fourth installment of the Medical Device User Fee Act, with FDA and industry representatives focusing attention on improving performance of the review process. Read More
The FDA has given its final word on how sponsors of implantable minimally invasive glaucoma surgical devices should conduct clinical and nonclinical studies to support a premarket approval. Read More
Colombia’s Instituta Nacional de Vigilancia de Medicamentos y Alimentos has updated regulations governing the sanitary requirements related to laboratories developing external orthopedic prosthetics and orthotics. Read More
The drumbeat for the removal of Bayer’s controversial implantable contraceptive device Essure is growing louder, with a federal lawmaker becoming the latest to urge the FDA to take it off the market until a well-designed study can demonstrate its safety and effectiveness. Read More