Draft Guidance for Industry and Food and Drug Administration Staff; Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review

Dear Sir/Madam: RE: Docket No. FDA-2011-D-0577 Attached please find comments of the Medical Imaging & Technology Alliance (MITA) in response to the FDA draft guidance document entitled, "Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Review," pursuant to the 76 Federal Register 50483, August 15, 2011. If you have any questions, please feel free 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)