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The devices include a mobile app, STIM onTrack, that allows physicians to remotely view a patient’s adherence to a prescription and allows patients to participate in their recovery through therapy reminders, educational resources and treatment calendars. Read More
Device validation procedures didn’t include predefined methods, operating conditions or acceptance criteria to ensure the device conformed to user needs and intended uses, the FDA said. Read More
The FDA handed Chicago-based Opternative a warning letter after a review of its website found it was marketing an online eye examination mobile medical app device without marketing clearance. Read More
The FDA issued warning letters to duodenoscope manufacturers Olympus, Fujifilm and Pentax for failing to comply with federal law requirements to conduct postmarket surveillance studies to assess the effectiveness of reprocessing the devices. Read More
The agency also detailed how to comply with the Postmarketing Safety Reporting Rule, noting the rule applies to both combination product applicants and constituent part applicants. Read More