In a recent report, the U.S. Department of Health & Human Services (HHS) Office of the Inspector General (OIG) recommended that the U.S. Food & Drug Administration (FDA) include cybersecurity review as a greater part of the...more
U.S. Senators Cory Gardner (R-CO) and Joe Donnelly (D-IN) recently introduced the Rare Device Innovation Act and the FDA Regulatory Efficiency Act. The bills, if passed, would streamline the U.S. Food and Drug Administration...more