PMA

FDA Warns Company for Marketing Medical Device

FDA 510(k), Disease Claims, FDA, Labeling, Medical Devices, PMA, Warning Letters

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 of the FFDCA because of several claims made on the Company’s website and other linked websites which contain claims that its light therapy device may be used to cure or treat fungal meningitis, concussions, Lyme disease and other illnesses. In addition, the FDA notes that…

FDA Approves First At-Home HIV Test

FDA FDA, HIV Test, Labeling, Medical Devices, PMA

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 in a vial where the results will be displayed within 20 to 40 minutes. Of course, like most other at-home tests, the FDA warns that the results of the test are not definitive in nature and that additional testing in a clinical setting should be…