Reprocessing Medical Devices in Health Care Settings Validation Methods and Labeling

Dear Sir/Madam: This letter represents the comments of the Medical Imaging & Technology Alliance (MITA) in response to the FDA's request for comments on the draft guidance document, "Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling," which was issued on May 2, 2011.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