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The FDA has taken action against a Louisiana diabetes firm for failing to satisfy medical device reporting (MDR) requirements for insulin pumps it imports from Korea.
An Italian firm was warned by the FDA this month for failing to meet quality system (QS) requirements in the manufacture of orthopedic medical devices.
The FDA has warned a Canadian device firm for a faulty medical device reporting (MDR) system and failure to report at least six serious injuries and device malfunctions.
The FDA has accused a Florida audiometry firm of manufacturing devices without an established quality system (QS) or medical device reporting (MDR) procedures as required by the agency to ensure the public's health and safety.
Former FDA Commissioner Mark McClellan’s exit will have no immediate impact on the Center for Devices and Radiological Health’s (CDRH’s) current practice of targeting routinely violative devicemakers for tougher enforcement action, according to Tim Ulatowski, director of CDRH’s Office of Compliance.
The FDA has accused Colorado-based TMJ Implants of failing to report a slew of incidents in which its dental joint devices were linked to serious injuries.
The FDA has warned Texas-based manufacturer Osteomed that it will no longer process premarket applications (PMA) submitted by the firm until numerous quality failures associated with the company’s surgical devices are resolved.
The failure of a U.S. cardiac monitor manufacturer to document the most basic elements of design and quality control in its medical device reporting has attracted the FDA’s attention.