MITA Comment Letters & Policy Papers

Comment Letters

  • MITA Comments on FDA Precertification Program

    MITA has submitted comments on the second iteration of the FDA’s Pre-certification, offering comments on ensuring excellence in the program. MITA also included proactive comments on issues which have not been previously addressed such as post-market surveillance activities, recalls, and de-certification. 2018.07.18 MITA Comments on Pre-cert v2

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  • DITTA MDSAP Working Group Sends Letter to US FDA

    The DITTA MDSAP group sent a letter to US FDA, copying Health Canada, suggesting improvements to the MDSAP program. The letter commended the MDSAP Consortium for holding an event for stakeholders, and urged FDA to implement changes to the program. These included updating training for auditors on interpreting findings, scope, and timelines, as well as Read More

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  • MITA Comments on Proposed Changes to the China Regulations for the Supervision and Administration of Medical Devices

    The MITA Global Affairs Committee submitted comments to the Chinese Ministry of Justice on proposed changes to their medical device regulations. The letter contained suggested edits to various aspects of the proposed changes, as well as edits to the existing language. MITA GAC comments on China proposed changes 7-2018

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  • MITA Comments to CMS HCPCS on Lutathera

    Dear Ms. Hake:   As the leading trade association representing the manufacturers of medical imaging equipment and radiopharmaceuticals, the Medical Imaging & Technology Alliance (MITA) is pleased to submit comments on the Centers for Medicare and Medicaid Services’ (CMS) HCPCS decisions for 2019.  MITA is pleased to work with CMS to ensure that assigned coding Read More

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  • MITA Letter to CMS HCPCS on NETSPOT

    Dear Ms. Hake:   As the leading trade association representing the manufacturers of medical imaging equipment and radiopharmaceuticals, the Medical Imaging & Technology Alliance (MITA) is pleased to submit comments on the Centers for Medicare and Medicaid Services’ (CMS) HCPCS decisions for 2019.  We are well informed and have in-depth knowledge of the significant benefits Read More

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Policy Papers

  • MITA Smart Dose for Computed Tomography (CT)

    The MITA Smart Dose standard identifies four key CT equipment features that enable optimization of radiation dose delivery without compromising the quality images necessary for an accurate diagnosis. The US Food and Drug Administration (FDA) and patient health organizations Image Gently and Image Wisely applauded MITA’s announcement of this important standard. Automatic Exposure Control Clinicians Read More

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