Disagreement among members of the Council of Europe over whether to allow reprocessing of single-use medical devices could hamper efforts to pass device reform legislation before next May’s EU elections. Read More

FDA user fees are protected from sequestration cuts for at least two years under Wednesday’s 64-36 Senate budget vote, which also recommends repeal of the medical device excise tax. Read More

The FDA and the Centers for Medicare & Medicaid Services announced Wednesday a two-year extension of the parallel review pilot program for medical devices, saying they need more time to evaluate the program’s effectiveness. Read More

Jay Crowley, who has been the FDA’s leading voice in explaining unique device identification to industry, is leaving the agency to join a California regulatory consulting group. Read More

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