The U.S. appeals court for the District of Columbia has reversed a lower court’s ruling that the device industry cannot appeal a Library of Congress rule that allows third-party access to the software used to govern the operations of medical devices. While the latest outcome in this controversy is a win for device makers, the trajectory of this case is anything but certain as the next step may be an en banc hearing at the circuit court or an appeal to the U.S. Supreme Court.
The U.S. Centers for Medicare & Medicaid Services has followed through on an earlier threat to reduce payments for various sorts of radiology services in the physician fee schedule, including those invoked during episodes of cancer care, but Congress may yet intervene.
The U.S. Centers for Medicare & Medicaid Services is once again in the crosshairs thanks to issues related to pharmacy benefits managers and coverage of novel medical devices, with Congress mulling over two dozen pieces of Medicare-related legislation.
The U.S. Centers for Medicare & Medicaid Services (CMS) is once again in the crosshairs thanks to issues related to pharmacy benefits managers and coverage of novel medical devices, with Congress mulling over two dozen pieces of Medicare-related legislation.
The proposed U.S. Medicare framework titled Transitional Coverage for Emerging Technologies (TCET) promises to expand on existing mechanisms for Medicare device coverage, but industry has serious misgivings about the proposal.
The U.S. Federal Trade Commission (FTC) has once again waded into the question of whether medical devices should be included in the agency’s right-to-repair discussion, most recently in an advanced notice of proposed rulemaking ostensibly titled for energy labeling. The Medical Imaging & Technology Alliance (MITA) pushed back on the proposal by pointing to the draft’s required disclosure of proprietary information about a medical device system, a provision MITA said might detract from patient safety.
The U.S. FDA’s guidance for electromagnetic compatibility (EMC) in medical devices has several moving parts, a consequence of the fact that the scope included cardiac electrophysiology devices and non-implantable medical devices. For the most part, the terms of the guidance will go into force within 60 days, but the compliance deadline for in vitro diagnostics (IVDs) doesn’t go into force until June 6, 2023, giving these manufacturers much more breathing room than their non-IVD counterparts.
The ongoing tension between manufacturers of imaging systems and entities that perform extensive servicing activities has prompted activity on Capitol Hill in the form of H.R. 7253, the Clarifying Remanufacturing to Protect Patient Safety Act.
The U.S. FDA has finally unveiled the fifth edition of the device user fee program (MDUFA V), and some of the performance measures remain unchanged from MDUFA IV, such as that the FDA will process 95% of 510(k) filings within 90 days.
The U.S. Senate narrowly voted 50-46 to confirm Robert Califf as the next commissioner of the FDA, a critical outcome for an agency that has lacked a fully anointed commissioner for a year. Califf, who was previously FDA commissioner under President Barack Obama from February 2016 to January 2017, faces several challenges in the coming year, however, including the agency’s accelerated approval program for prescription drugs, which has added drag to the process of registering him as the new commissioner.
