Comment Letters, Policy Papers & Testimony

Comment Letters

• Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs

  Comments on the Federal Register Notice on the Draft Guidance: “Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs” as announced in the Federal Register, 77 Federal Register 8262, February 14, 2012. MITA represents multiple radiopharmaceutical PET manufacturers, and is thus interested in commenting on, and appropriate implementation of, this draft guidance.

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• Comments on IRS Proposed Regulations on the Excise Tax Imposed on the Sale of Medical Devices (REG-113770-10)

  Dear Mr. Commissioner: The Medical Imaging and Technology Alliance (MITA) welcomes this opportunity to  comment on the regulations proposed by the IRS (REG-113770-10) to provide guidance on the new excise tax on medical devices under Internal Revenue Code section 4191, as enacted by section 1405 of the Health Care and Education Reconciliation Act of 2010 Read More

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• Comments Regarding HERC Draft Coverage Guidance: MRI for Breast Cancer Screening

  Comments on the Health Evidence Review Commission’s (HERC) draft coverage guidance for the use of MRI for breast cancer screening. As the leading trade association representing medical imaging and radiotherapy technology manufacturers, we have an in-depth understanding of the significant benefits to the health of women that breast MRI provides, particularly those at high risk for breast cancer.

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• Medical Device Classification Product Codes

  Comments on the Notice of Availability of the draft guidance document, “Medical Device Classification Product Codes,” as announced in the Federal Register, 77 Federal Register 125, January 3, 2012.

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• Center for Devices and Radiological Health Appeals Processes

  This letter represents the comments of the Medical Imaging & Technology Alliance (MITA) in response to the Notice of Availability of the draft guidance document, “Center for Devices and Radiological Health Appeals Processes,” as announced in the Federal Register, 76 Federal Register 81511, December 28, 2011.

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Policy Papers

• Value of Ultrasound

  Diagnostic ultrasound has multiple uses in today’s clinical practice being used for primary diagnosis and monitoring of known conditions to guidance of minimally invasive surgical procedures.

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• The Value of the Right Scan at the Right Time: Promoting Appropriate Use of Imaging Services

  Medical imaging tests are central to modern patient-care. They ensure that life-threatening health
  conditions are caught early and Medicare beneficiaries can be treated sooner. This prevents the
  need for more invasive, and often more costly, diagnostic procedures as well as the monetary and
  emotional costs due to late-stage diagnosis.

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• List of Dose Reduction Features for Several CT Manufacturers

  List of dose reduction features for the following CT manufacturers: GE Healthcare, Hitachi Medical Systems, NeuroLogica, Neusoft Medical Systems, Philips Healthcare, Siemens Medical Solutions,Toshiba America Medical Systems…

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• MITA 2011 Issues

  MITA’s 2011 positions on Medical Device User Fee Act (MDUFA) Negotiations, Reimbursement for Imaging and Radiation Therapy Services, Medical Device Tax, Medical Radiation

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• The Importance of the 510(k) Clearance Process

  Health care providers and patients understand that the key to improving our health care system lies in promoting medical innovation…

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Testimony

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