A supplier of respiratory durable medical equipment pays $5.3M to resolve False Claims Act allegations; Two physicians receive prison sentences for their roles in a durable medical equipment Medicare Fraud scheme; The FDA posts a warning letter issued to a London-based dental device manufacturer for failing to submit a 510(k) for making changes to their device and for failing to comply with a broad range of regulatory requirements; The FDA posts its updated Data Standards Catalog; The White House Office of Management and Budget See more +

A supplier of respiratory durable medical equipment pays $5.3M to resolve False Claims Act allegations; Two physicians receive prison sentences for their roles in a durable medical equipment Medicare Fraud scheme; The FDA posts a warning letter issued to a London-based dental device manufacturer for failing to submit a 510(k) for making changes to their device and for failing to comply with a broad range of regulatory requirements; The FDA posts its updated Data Standards Catalog; The White House Office of Management and Budget begins reviewing a proposal for Medicare coverage of breakthrough devices; the U.S. Department of Commerce issues a proposed rule placing export controls on automated peptide synthesizers. See less -