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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 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
If an accessory request included in a cleared or approved submission is denied, the new accessory type “will be considered to be in the same classification… Read More