CDRH

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 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…

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…

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…