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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 rapped Maitland Engineering for numerous deficiencies including a lack of validation for testing, inadequate process controls and protocols for rework of nonconforming product. 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 cited the firm for failing to secure pre-market approval for the app as well as for misbranding because the company failed to notify the FDA it was introducing the device to the market. Read More
The FDA cited two device manufacturers and an importer after inspections identified issues with procedures, including product acceptance, complaint handling and medical device reporting. Read More