Comment Letters
-
Dear Captain Sears and Mr. Keith: The Medical Imaging and Technology Alliance (MITA) appreciates the opportunity to comment on the U.S. Environmental Protection Agency (EPA), Interagency Working Group on Medical Radiation, Federal Guidance Report Number 14: Radiation Protection Guidance for Diagnostic and Interventional X-Ray Procedures (the “guidance”). This guidance sets forth recommendations for Federal facilities Read More
-
Industry letter asking the Centers for Medicare and Medicaid Services’ (CMS) to withdraw its proposal to use separate cost centers for computed tomography (CT) and magnetic resonance (MR) in the FY 2014 Inpatient Prospective Payment System (IPPS) rule and to avoid including an extension of such a proposal in the CY 2014 Outpatient Prospective Payment System (OPPS) rule.
-
Dear Chairman Baucus and Ranking Member Hatch: The Medical Imaging & Technology Alliance appreciates this opportunity to provide you with our feedback on your efforts to reform the Medicare Physician Fee Schedule (PFS). MITA is the collective voice of medical imaging equipment, radiation therapy, and radiopharmaceutical manufacturers, innovators, and product developers. We work closely with Read More
-
MITA comments on the Food and Drug Administration’s (FDA) draft guidance on Distinguishing Medical Device Recalls from Product Enhancements and Associated Reporting Requirements.
-
The Medical Imaging & Technology Alliance (MITA) is grateful for the opportunity to provide feedback on the 5th Edition of the Joint Commission International Accreditation Standards for Hospitals. In addition to MITA members, we have brought together companies representing the broad spectrum of the medical technology community from small implantable devices to large capital equipment. We share the commitment in your mission statement to “continuously improve the safety and quality of care in the international community.”
-
04.11.13
RE: Proposed Decision Memorandum for Positron Emission Tomography for Solid Tumors (CAG-00181R4)
MITA comment letter sent to CMS on a proposed decision memo for lifting CED requirements in oncologic PET scans.
-
US/EU medical technology industry input presented at the High Level Regulatory Cooperation Forum Stakeholder Session on the Transatlantic Trade and Investment Partnership (TTIP).
-
04.11.13
Joint EU-US Industry Contribution
Safety of medical devices is one of the common goals for regulators, patients, and healthcare professionals, next to high quality, performance, easy access and cost effectiveness. Our industry remains highly committed to provide such devices at the earliest possibility.
-
MITA comments on Notice 2012-77, which was issued in conjunction with the final regulations on the excise tax on medical devices under Internal Revenue Code section 4191.
-
Agência Nacional de Vigilância Sanitária (Brazil National Health Surveillance Agency) GMP (Good Remanufacutring Practices) Public Consultation No. 02, dated of January 07, 2013, DOU [Federal Official Gazette] 01/08/2013






