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Tag: PMA

FDA Warns Company for Marketing Medical Device

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

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 …

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FDA Approves First At-Home HIV Test

FDA, HIV Test, Labeling, Medical Devices, PMAFDA

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 …

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510(k) Adverse Events Allergens Beverages CDRH CGMP Cosmetics Dietary Supplements Disease Claims Drug Drugs Enforcement FDA Food Food Facility Registration Food Safety Modernization Act FSMA FTC Gluten-Free GRAS Guidance imports Injunction Labeling Listeria mad cow Medical Devices NDA Nutrition Facts off-label promotion off-label use Orphan Designation Orphan Drug PMA post-marketing studies Recalls Rulemaking Salmonella Structure-Function Claims Substantiation Tobacco Control Act Tobacco Products Tobacco Warning Letter USDA Warning Letters

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Recent Posts

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  • FDA Warning Letters for Alzheimer’s Supplement Claims
  • FDA Considers Changing Major Food Allergen Labeling Requirements
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