We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
The FDA flagged almost a dozen devicemakers for noncompliances observed during agency inspections, including inadequate medical device reporting. Read More
The FDA warned three devicemakers in Germany, The Netherlands and the U.S. for GMP and other violations, including inadequate responses to a Form 483 report. Read More
The FDA recommended the addition of a contraindication for the use of certain ultrasonic surgical aspirator devices for removing uterine fibroids. Read More