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The FDA is now monitoring about 90 medical products, including devices, biologics, and drugs, that are manufactured in Puerto Rico and are critical to patient health. Read More
The California company received complaints about patients who required prescription antibiotics for pin site infections developed while being treated with the Digit Widget device. Read More
The agency has authority to exempt class II devices from requiring 510(k) submissions if it can determine that a 510(k) clearance is not necessary to assure their safety and effectiveness. Read More