The FDA’s proposed framework for health IT regulation, due to Congress by January, will likely focus heavily on adverse event reporting and data collection, an attorney who has worked with the agency on developing the framework predicts. Read More

A proposed policy that would allow hospitals to set their own maintenance schedules for medical equipment could pose a significant risk to users of imaging and radiological devices, a coalition of medical societies says. Read More

The FDA’s device center needs to improve consistency in decisionmaking during premarket reviews and ensure all employees are up to speed on its review software systems, Booz Allen Hamilton says in a preliminary set of priority recommendations on the review process. Read More

Industry can expect an international effort to revise and update software device standards over the next few years, CDRH Director Jeffrey Shuren says. Read More

Industry got two wins in Tuesday’s bipartisan budget deal, which recommends the repeal of the 2.3 percent medical device excise tax and removes the threat of sequestration hanging over fiscal 2014 and 2015 FDA user fees. Read More

The FDA’s final guidance on unique device identification should allow for submission of UDI data elements within 10 days of commercializing a device, rather than requiring that they be in the Global UDI Database before market launch, as the stricter requirement could lead to lost sales, AdvaMed says. Read More