Dec 16, 2011· Medical Imaging & Technology Alliance (MITA) - Comment· FDA-2011-D-0567-0012
Dear Sir/Madam: RE: FDA-2011-D-0567 The attached letter represents the comments of the Medical Imaging & Technology Alliance (MITA) on the draft guidance entitled, "Design Considerations for Pivotal Clinical Investigations for Medical Devices," as announced in the Federal Register, 76 Federal Register 50484, August 15, 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)