Comment Letters

  • January 14, 2011 Jeffrey Shuren, Ph.D. Director, Center for Devices and Radiological Health Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 Dear Dr. Shuren, Thank you for your letter on November 8, 2010 to MITA, and for FDA suggestions for CT manufacturers to enhance the information provided to users in order Read More

  • This letter represents the comments of the Medical Imaging & Technology Alliance (MITA), and comes in response to the Request for information by the Office of the National Coordinator (ONC) for Health Information Technology, which was issued on December 10, 2010 in the Federal Register, 75 Federal Register 76986, FR DOC NO: 2010-31159.

  • MITA believes that the Preliminary Draft Recommendations are flawed due to their failure to incorporate the communication of images as a priority recommendation for Stage 2 Meaningful Use. It is important to note that communication of imaging information between providers through use of the Digital Imaging and Communications in Medicine (DICOM) Standard, Integrating the Healthcare Enterprise (IHE) Profiles, and other tools, also does not appear anywhere in the Work Group’s Preliminary Draft Recommendations.

  • We would like to thank you for your recent decision with regard to contrast agents and imaging equipment. It is our understanding that FDA will permit contrast agent indications that have been previously cleared to once again be included in manufacturer labeling.

  • The Medical Imaging and Technology Alliance (MITA) appreciates this opportunity to comment on the Highmark LCD for Non-Vascular Extremity Ultrasound (DL 30271) and Highmark LCD for Non-Vascular Extremity Ultrasound for Guidance of Injection and Aspiration Procedures (DL31683).

  • On behalf of the Medical Imaging and Technology Alliance (MITA), I would like to express our strong support for House Bill 1212 and urge all Committee members to vote to pass this important bill.

  • The Medical Imaging and Technology Alliance (MITA) appreciates this opportunity to comment on the Centers for Medicare and Medicaid Services’ (CMS) proposed rule on the Hospital Inpatient Value-Based Purchasing (VBP) Program (the “Proposed Rule”).

  • The Medical Imaging and Technology Alliance (MITA) appreciates this opportunity to comment, pursuant to I.R.S Notice 2010-89, regarding issues that should be addressed in regulatory guidance implementing 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 (Public Law 111-152).

  • MITA has long supported the efficient use of imaging equipment and looks forward to working with you to continue to improve the healthcare of Medicare beneficiaries through appropriate use of these technologies for the early detection, diagnosis, staging, therapy monitoring, and surveillance of many diseases.

  • This letter represents the comments of the Medical Imaging & Technology Alliance (MITA) in response to FDA’s request for comments on the report entitled “FDA Transparency Initiative: Improving Transparency to Regulated Industry,” as announced in the Federal Register, 76 Federal Register 1180, January 7, 2011.