Comment Letters

  • Senators Elizabeth Warren (D-MA) and Bill Cassidy (R-LA), who actively support MITA’s position on servicing, sent a letter to the FDA last week telling the agency they look forward to the timely completion of their upcoming service report. In 2017, MITA successfully secured language in the Medical Device User Fee Amendments to the FDA Reauthorization Act requiring the FDA to complete a report on the state of medical device servicing within 280 days of the legislation being signed into law. MITA anticipates the report, if release on scheduled, this week. MITA is planning a congressional briefing on the issue in June and is actively meeting with key Congressional offices.

  • May 10, 2018 The Honorable Robert Lighthizer United States Trade Representative 600 17th Street NW Washington, DC 20508 RE: China 301 Public Comments (Docket USTR-2018-0005)   Dear Ambassador Lighthizer,   As the leading trade association representing the manufacturers of medical imaging devices and radiopharmaceuticals, the Medical Imaging and Technology Alliance (MITA) takes this opportunity to Read More

  • MITA urges the CA Senate to pass CA SB 1034. If enacted, SB 1034 would require CA to continue to notify women of their breast density if they are found to have heterogenously dense or extremely dense breasts.

  • MITA led efforts with the Senate Health, Education, Labor and Pensions (HELP) Committee to secure language in the Opioid Crisis Response Act of 2018 that supports grants for protocol development and testing that includes the use of ultrasound-guided procedures, including cutting-edge techniques such as focused ultrasound therapy and regional anesthesia for the purpose of opioid Read More

  • The Senate Health, Education, Labor and Pensions Committee (HELP) is seeking ideas to address the opioid addiction crisis. MITA sent a letter to HELP to consider including S. 2516, the “Alternatives to Opioids (ALTO) in the Emergency Department Act,” sponsored by Senators Cory Booker (D-NJ) and Shelley Capito (R-WV).

  • The MITA Ultrasound Section and Technical Committee submitted comments to the Society of Diagnostic Medical Sonography (SDMS) on their recently released Guidelines for Infection Prevention and Control in Sonography.

  • On April 12, MITA submitted comments on S. 180. S. 180, Vermont’s “Right to Repair” bill is currently under consideration as a study bill in the Vermont House.

  • MITA has submitted comments on FDA’s Least Burdensome proposed rule. In these comments, MITA expresses support for the policy, but cautions against scope creep and encourages the FDA to adhere to the commitments it made in the latest MDUFA commitment.

  • MITA submitted comments to VA in response to a recent Federal Register (FR) notice proposing significant changes to VA Acquisition Regulations (VAAR). MITA’s comments emphasized that substantial changes to the VAAR at this time are premature given the open questions regarding guidance, applicability, and impact of the Kingdomware Supreme Court Decision.

  • MITA supports H.R. 4122 and S. 2006, The Breast Density and Mammography Reporting Act of 2017