Draft Guidance for Industry and Food and Drug Administration Staff; Evaluation of Sex Differences in Medical Device Clinical Studies; Availability

Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane Rockville, MD 20852 RE: FDA-2011-D-0817 Dear Sir/Madam: Attached please find comments of the Medical Imaging & Technology Alliance (MITA) in response to the Notice of Availability of the draft guidance document "Draft Guidance for Industry and Food and Drug Administration Staff; Evaluation of Sex Differences in Medical Device Clinical Studies," as announced in the Federal Register, 76 Federal Register 78670, December 19, 2011. If you have any questions, please feel free to contact me at reaton@medicalimaging.org or by phone at 703 841 - 3248. Sincerely, Richard M. Eaton, Industry Manager, Medical Imaging & Technology Alliance (MITA)