On June 5, 2012, the Office of the Inspector General (“OIG”) published a report entitled, “Executive Summary: Scientific Disagreements Regarding Medical Device Regulatory Decisions.” The Summary, found here, details a study undertaken by the OIG, an office in the Department …
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 Respiratory Panel, a medical device used to detect causes of respiratory infection. Manufactured by Idaho Technology, Inc., the device is …
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 various strategies undertaken by the agency to ensure that FDA-regulated products, including foods, medical devices, drugs, etc., are manufactured under …
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 lower the regulatory classification for nucleic acid-based tuberculosis tests. These tests, which are currently classified as Class III medical devices, …