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…
54 years ago
Medical Devices
FDA Guides on General Wellness and Low Risk Devices
On January 20, 2015, the U.S. Food and Drug Administration (FDA) published a proposed guidance document regarding the FDA’s current…
54 years ago
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…
54 years ago
FDA Finalizes Rule Requiring Unique Device Identification for Medical Devices
On September 20, 2013, the U.S. Food and Drug Administration (FDA) published a final rule that establishes the Unique Device…
54 years ago
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”…
54 years ago
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…
54 years ago
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…
54 years ago
FDA Targets Online Pharmacies in International Efforts
On October 4, 2012, the U.S. Food and Drug Administration (“FDA”) announced that it has taken action as part of…
54 years ago
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…
54 years ago
FDA Approves First At-Home HIV Test
On July 3, 2012, the U.S. Food and Drug Administration (“FDA”) approved the first over-the-counter (“OTC”) at-home test kit used…
54 years ago