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If the FDA conducts a benefit-risk assessment and finds the device has a high benefit to patients and the compliance issue causes little risk, it may decide to work with a company informally, rather than taking an official enforcement action. Read More
Indian regulators have decided to abandon a proposed law that would have amended parts of India’s Drugs and Cosmetic Act of 1940, to pursue more extensive revisions to create a separate device regulation. Read More
Ireland’s Health Products Regulatory Authority is temporarily banning use of Biotest’s RightSign rapid tests for HIV, HCV and HBV distributed in the Irish market. Read More
Spot On Sciences marketed its products for diagnostic testing despite telling the FDA they were intended for research use only, according to a recent warning letter. Read More