Medical Devices

• 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…

• FDA

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

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…