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Medmarc Blog (blog.medmarc.com)

CMS Issues Final Policy For Breakthrough Device Coverage

August 30, 2024

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

July 31, 2024

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

June 13, 2024

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

June 12, 2024

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

May 14, 2024

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

April 24, 2024

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

March 11, 2024

The FDA has issued a new draft guidance for the disclosure of information in informed consent (IC) documents that will align with an overarching rule by the Department of Health and Human Services...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

March 06, 2024

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...