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A new IVD application for priority review status should include a justification for how early market availability in the country will result in improved health. Read More
The South Korean government reached an agreement with the nation’s medical device industry to adopt accelerated approval procedures for certain devices. Read More
Member medical device companies at four of the top industry trade associations worldwide have made a major change in how they support healthcare professionals’ education and training. Read More
The shift to increased patient input for device development and clinical trials in recent years has been more challenging than expected, according to participants at the FDA/CMS Summit. Read More
Hand Biomechanics Lab, a manufacturer of bone fixation fastener systems in Sacramento, California, was hit with an FDA warning letter for failing to submit MDRs and for GMP nonconformities. Read More
Evidence introduced by Cook to challenge the BSI patent had initially convinced the board of reasonable likelihood for the first 19 claims to be unpatentable. Read More
MDR reports often “describe the same problem, creating a process where the FDA conducts duplicate reviews of common malfunctions,” said CDRH Director Jeff Shuren. Read More