The $1.3 million IOM review will be asking whether the current clearance process protects patients and promote innovation, and, if not, whether any legislative, regulatory or administrative changes are needed.
The IOM will hold two public workshops on the matter in the next nine months and publish a final report in March 2011.
Read the FDA’s release on its medical device clearance process.
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.
