FDA to Block Imports of Rubimed's Biofeedback Devices for PMA, CGMP, MDR Violations
The Food and Drug Administration is taking steps to refuse admission of Rubimed’s REBA Feedback Devices, after discovering that the Switzerland-based company does not have a valid approved premarket approval application for the device, the agency said in a warning…
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letter dated May 6. The device will be put on detention without physical examination for the violations, which also include deviations from current good manufacturing practices and failure to comply with Medical Device Reporting requirements, FDA said.