Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device

Dear Sir/Madam: RE: Docket No. FDA-2011-D-0453 The attached document represents the comments of the Medical Imaging & Technology Alliance (MITA), in response to the draft guidance entitled, "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device," as announced in 76 Federal Register 44935, July 27, 2011. If you have any questions, please contact me directly at (703) 841 - 3248 or by email at reaton@medicalimaging.org. Sincerely, Richard M. Eaton, Industry Manager, Medical Imaging & Technology Alliance (MITA)

Dear Sir/Madam: RE: Docket No. FDA-2011-D-0453 Attached is the comment letter from the Medical Imaging & Technology Alliance (MITA) in response to the draft guidance: "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device," as announced in the Federal Register, 76 Federal Register 44935, July 27, 2011. If you need further information, please do not hesitate to contact me at 703 841 - 3248 or by email at reaton@medicalimaging.org. Sincerely, Richard M. Eaton, Industry Manager, Medical Imaging & Technology Alliance (MITA)