Device Improvements to Reduce Unnecessary Radiation Exposure From Medical Imaging; Public Meeting; Request for Comments

Division of Dockets Management (HFA-305)April 15, 2010 Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852Submitted to: http://www.regulations.gov Re: Docket Number FDA-2010-N-0080, 75 Fed. Reg. 8375-8377 (Feb. 24, 2010) (Device Improvements to Reduce Unnecessary Radiation Exposure From Medical Imaging; Public Meeting; Request for Comments) To Whom It May Concern: The Medical Imaging & Technology Alliance (MITA), a division of the National Electrical Manufacturers Association (NEMA), is the collective voice of medical imaging and therapy equipment manufacturers, innovators, and product developers. It represents companies whose sales comprise more than 90 percent of the global market for these technologies. In response to the Federal Register Notice of the subject meeting MITA herewith submits its comments on the questions listed in the Notice. The MITA comments are presented in five parts: •CT device specific statements on FDA Questions A1-A12 •Fluoroscopic device specific statements on FDA Questions A1-A12 •Statements on FDA Training Questions B1-B3 •Statements on FDA Quality Assurance Questions C1-C2 •Statements on FDA Metrics related Question D1 The above 5 parts are submitted as 5 separate files named accordingly. Thank you for your consideration of these comments. Respectfully, Stephen Vastagh Industry Director, X-Ray Imaging Section Medical Imaging & Technology Alliance a Division of NEMA 1300 N 17th St, Suite 1752 Arlington, VA 22209, USA 703-841-3281 svastagh@medicalimaging.org Cc: Contact Person: Mr. Simon Choi, mailto:simon.choi@fda.hhs.gov