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The appeals court said the district court correctly interpreted the “plain language” of how the cylinder “verifies” the nitric oxide being released. Read More
CDRH says the priorities will help improve the “safety, effectiveness, performance and quality of medical devices and radiation-emitting products.” Read More
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
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