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Devicemakers should also submit device classification applications to seek classification determination opinions for any new devices not covered by the catalogue or notices. Read More
A CDRH official called the clearance of Pentax of America’s ED34-i10T a major step toward lowering the risk of infections associated with the devices. Read More
An Ohio company violated federal regulations for medical devices by making claims for its product that were not approved by the FDA, the agency said in a warning letter. Read More