510(k) – FDA Compliance Made Easy

FDA Clears Device via De Novo Process

On December 8, 2015, the U.S. Food & Drug Administration (“FDA”) cleared for marketing in the United States a cooling cap to reduce hair loss in breast cancer patients undergoing chemotherapy. Marketed under the name the DigniCap® Cooling System, the …

Court Finds FDA Exceeded Authority in Device Reclassification

510(k), FDA, Medical Devices, RulemakingFDA

On September 26, 2014, The United States Court of Appeals for the District of Columbia Circuit ruled that the FDA had “short circuited” its procedural requirements, pertaining to device reclassification and formal rulemaking, when it reevaluated a medical device being …

FDA Issues Letter for Failure to Obtain 510(k) Clearance for Medical Mobile App

510(k), Disease Claims, FDA, intended use, Medical Devices, medical mobile appFDA

On March 21, 2013 the U.S. Food & Drug Administration (FDA) issued an “It Has Come to Our Attention Letter” to Biosense Technologies Private Limited for failure to obtain 510(k) clearance for its medical mobile app, uChek Urine Analyzer. The …

FDA Permits Marketing of Device Capable of Testing for 11 Causes of Infectious Gastroentiritis

510(k), de novo classification, FDA, Medical DevicesFDA

On January 14, 2013, the U.S. Food and Drug Administration (FDA) announced that for the first time it will permit marketing for a new diagnostic test that has the ability to simultaneously detect up to eleven (11) prevalent bacterial, viral, …

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 …

FDA Proposes New Unique Identifier System for Medical Devices

510(k), CGMP, FDA, Medical DevicesFDA

On July 3, 2012, the U.S. Food and Drug Administration (“FDA”) announced its intention to require most medical devices in the United States to bear a Unique Device Identifier (“UDI”). According to the FDA, this UDI system could potentially improve …

Study Prompts OIG to Call for Further Training of FDA Medical Device Reviewers

510(k), CDRH, FDA, Medical Devices, OIGFDA

On June 5, 2012, the Office of the Inspector General (“OIG”) published a report entitled, “Executive Summary: Scientific Disagreements Regarding Medical Device Regulatory Decisions.” The Summary, found here, details a study undertaken by the OIG, an office in the Department …

FDA Expands Use of Device to Detect both Viral and Bacterial Causes of Respiratory Infection

510(k), CGMP, FDA, Medical Devices, Respiratory InfectionFDA

On May 15, 2012, the U.S. Food and Drug Administration (“FDA”) announced the clearance of expanded uses for the FilmArray Respiratory Panel, a medical device used to detect causes of respiratory infection. Manufactured by Idaho Technology, Inc., the device is …