Medical Devices
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 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…
FDA Publishes Global Engagement Report, Highlighting Efforts Abroad
On April 23, 2012, the U.S. Food and Drug Administration (“FDA”) released its “Global Engagement Report,” a document detailing the…
FDA Proposes Reclassification of Tuberculosis Tests
On March 16, 2012, the U.S. Food and Drug Administration (“FDA”) announced its issuance of a proposed rule intended to…