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The app is intended for use by clinicians to diagnose lower respiratory tract disease, croup, pneumonia, asthma/reactive airway disease and bronchiolitis in infants and children. 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
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