Mar 14, 2012· Medical Imaging & Technology Alliance (MITA) - Comment· FDA-2011-D-0790-0012
Dear Sir/Madam: The attached letter represents the comments of the Medical Imaging & Technology Alliance (MITA) in response to the Notice of Availability of the draft guidance, "Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards and Food and Drug Administration Staff: FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations," as announced in the Federal Register, 76 Federal Register 70151, November 10, 2011. If you have any questions, please contact me at 703 841 - 3248 or by email at reaton@medicalimaging.org. Sincerely, Richard M. Eaton, Industry Manager, Medical Imaging & Technology Alliance (MITA)