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 medical device regulations become fully applied in May 2020. Some in the device industry believe that the regulations’ three-year implementation period is too short. Read More
The firm’s response to Form 483 inspection observations indicated quality audits were being performed, but “with poorly defined requirements,” the agency said. Read More
Complaints of software-related performance problems did not go through the firm’s complaint handling procedure, which meant they were not evaluated to determine if the events should be reported to the FDA. Read More
The procedure didn't require all service records to be evaluated for potential complaints, and the firm had not conducted the procedure since 2016. Read More
The Fitbit devices will motivate participants to “adopt healthier habits and achieve better outcomes in the areas of physical activity, sleep, nutrition and emotional wellbeing,” the company said. Read More