The FDA has announced an opportunity for public comment on the statement of work for an assessment for the process of review of medical device submissions. Under the Medical Device User Fee Act of 2012 (MDUFA III), which gives FDA the authority to collect device user fees from industry for 2013-2017, FDA has committed to reaching certain performance goals. Among others, FDA is committed to participate, with the device industry, in a comprehensive assessment of the process for the review of device applications. The assessment will be conducted in two phases by a private, independent contractor. FDA is providing a comment period on the statement of work before requesting proposals for the assessment. Comments should be submitted in writing or electronically, at www.regulations.gov, by February 4, 2013.