Tag Archive: PMA

Nov 11

FDA Warns Company for Marketing Medical Device

On November 5, 2012, the U.S. Food and Drug Administration (“FDA”) announced recent action the Agency has taken against a Tennessee-based company in connection with the Company’s alleged violations of the Federal Food, Drug and Cosmetic Act (“FFDCA”). According to the FDA’s Press Release, found here, The Avalon Effect, Inc. (“the Company”) is in violation …

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Jul 03

FDA Approves First At-Home HIV Test

On July 3, 2012, the U.S. Food and Drug Administration (“FDA”) approved the first over-the-counter (“OTC”) at-home test kit used to detect human immunodeficiency virus (“HIV”). According to the FDA’s announcement, the OraQuick In-Home HIV Test allows the user to collect an oral fluid sample by first swabbing the gums. Thereafter, the sample is placed …

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