Medmarc Blog (blog.medmarc.com)
CMS Issues Final Policy For Breakthrough Device Coverage
The Centers for Medicare & Medicaid Services has delivered its final policy for the Transitional Coverage for Emerging Technologies (TCET) program, which incorporates existing coverage mechanisms....
Supreme Court Ruling Ends Courts’ Deference under Chevron
The Supreme Court of the United States has overturned a landmark legal doctrine of judicial deference to federal government agencies during litigation in federal courts. The 6-3 decision addresses...
FDA Final Rule for LDTs Offers Four-Year Phase-In
The FDA’s final rule for laboratory-developed tests (LDTs) imposes a large compliance burden on clinical laboratory operations, a fact which has sparked renewed interest in legislation. However, the...
Congress Reconsiders Expanding Telehealth Services for Diabetes Prevention
The House of Representatives and the Senate have both reintroduced legislation that would expand Medicare telehealth services for patients at risk for developing diabetes. The PREVENT DIABETES Act...
FDA’s Posts Final Guidance for Remanufacturing
The FDA has issued a final guidance for servicing and remanufacturing services for medical devices, which will end the agency’s enforcement discretion for remanufacturing activities. Manufacturers...
GAO Report Highlights FDA Staff Shortages for BiMo Inspections
The U.S. Government Accountability Office stated in a recent report that the FDA’s ability to fill openings in its Bioresearch Monitoring (BiMo) workforce has been impeded by several factors, such...
FDA Proposes New Formats for Informed Consent
The FDA has issued a new draft guidance for the disclosure of information in informed consent (IC) documents that will align with an overarching rule by the Department of Health and Human Services...
FDA’s Quality System Final Rule a Significant Revision
The FDA has published an updated version of its quality management requirements for medical devices, which is known as the Quality Management System Regulation (QMSR). This rule differs from the...