Comment Letters

  • Dear Ms. Kux: As the premier trade association representing the manufacturers of medical imaging equipment and radiopharmaceuticals, the Medical Imaging & Technology Alliance (MITA) is responding to the public docket on the draft guidance on Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”). General Comments MITA and its members believe that Public Notification Read More

  • Dear Ms. Kux: As the leading trade association representing the manufacturers of medical imaging equipment and radiopharmaceuticals, the Medical Imaging & Technology Alliance (MITA) is responding to the FDA’s Fiscal Year 2016 Proposed Guidance Development. We are pleased the FDA continues to seek input for prioritization of the Agency’s guidance development and review. General Comments Read More

  • March 1, 2016 BY ELECTRONIC DELIVERY Re: Centers for Medicare & Medicaid Services Quality Measure Development Plan Dear Acting Administrator Slavitt: As the premier trade association representing the manufacturers of medical imaging equipment and radiopharmaceuticals, the Medical Imaging & Technology Alliance (MITA) is submitting the following comments on the CMS quality measure development plan. Our Read More

  • March 1, 2016 BY ELECTRONIC DELIVERY Re: CMS Episode Groups Dear Acting Administrator Slavitt: As the leading trade association representing the manufacturers of medical imaging equipment and radiopharmaceuticals, the Medical Imaging & Technology Alliance (MITA) would like to submit the following comments on the proposed CMS episode groups. Our comments address the important role of Read More

  • Dear Commissioner Califf: As the leading trade association representing the manufacturers of medical imaging equipment and radiopharmaceuticals, the Medical Imaging & Technology Alliance (MITA) congratulates you on your confirmation as Commissioner of Food and Drugs. The FDA plays a central role in assuring the quality and safety of medical imaging equipment and ensuring the science Read More

  • Dear Ms. Kux: As the leading trade association representing the manufacturers of medical imaging equipment and radiopharmaceuticals, the Medical Imaging & Technology Alliance (MITA) is responding to the public docket on the FDA Workshop entitled, Moving Forward: Collaborative Approaches to Medical Device Cybersecurity. We are pleased the FDA is seeking input from all stakeholders regarding Read More

  • Dear Chairman Upton and Chairman Pitts: As the leading trade association representing the manufacturers of medical imaging equipment and radiopharmaceuticals, the Medical Imaging & Technology Alliance (MITA) appreciates this opportunity to comment on site neutral payment policies. Our comments address two primary concerns: 1) Implementation of site neutral payment policies could have negative implications for Read More

  • Dear Chairman Shuster and Chairman Lo Biondo: We write to express our support for Section 615 of H.R. 4441, the Aviation, Innovation, Reform and Reauthorization (AIRR) Act and retention in current law of Section 828 of the bi-partisan FAA Modernization and Reform Act of 2012 (49 U.S.C. 44701 note). It will ensure the continued harmonization of lithium Read More

  • Dear State of California Government Operations Agency: The Medical Imaging & Technology Alliance (MITA) has been actively engaged in providing comments for changes in the 2016 California Building Code, Title 24. We are offering the following comments with respect to the Office of Statewide Health Planning and Development (OSHPD) 04/15: California Administrative Code, Part 1 Read More

  • Re: Comments on Proposed Decision Memorandum (CAG-00065R2) Positron Emission Tomography (NaF-18) to Identify Bone Metastasis of Cancer Dear Director Syrek Jensen: The Medical Imaging & Technology Alliance (MITA) appreciates this opportunity to submit comments to express its serious concerns with the referenced proposed decision memorandum on the Centers for Medicare & Medicaid Services (CMS) National Read More



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