510(k)

• FDA

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…

• FDA

Court Finds FDA Exceeded Authority in Device Reclassification

On September 26, 2014, The United States Court of Appeals for the District of Columbia Circuit ruled that the FDA…

• FDA

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”…

• FDA

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…

• FDA

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…

• FDA

FDA Proposes New Unique Identifier System for Medical Devices

On July 3, 2012, the U.S. Food and Drug Administration (“FDA”) announced its intention to require most medical devices in…

• FDA

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…

• FDA

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…