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

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

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, …

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

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

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 …