Medmarc Blog (blog.medmarc.com)
Lab Developed Tests
FDA Appoints New Director for Center for Devices
The FDA has appointed a new director for the Center for Devices and Radiological Health (CDRH) to replace Jeff Shuren, who has been at the helm of CDRH since 2009. Michelle Tarver has taken over as...
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...
FDA Proposes End to Enforcement Discretion for Lab-Developed Tests
The FDA has released a draft rule for regulation of lab-developed tests (LDTs) that would terminate the existing policy of enforcement discretion over a period of approximately four years. The...
Congress Passes Budget Omnibus without VALID Act
The U.S. Senate and House of Representatives have concluded their work on the budget for fiscal year 2023, sending the Consolidated Appropriations Act (CAA) to the White House for President...
Congress Passes FDA User Fee Legislation
The U.S. Congress has passed legislation that reestablishes the FDA user fee programs for medical devices and pharmaceuticals as part of a continuing resolution for the federal fiscal year 2023...
House User Fee Bill Emphasizes Inspections
The House of Representatives is processing legislation to renew the FDA’s user fee programs, a bill that includes a number of key provisions for drug and device makers alike. The bill is likely to be...
Congress Pushes CMS to Reconsider MCIT Program
The Centers for Medicare & Medicaid Services has formally scuttled its proposal to cover breakthrough medical devices, but recent developments have breathed new hope into the Medicare Coverage...
Controversies over Diagnostics Renewed
Controversies over Diagnostics Renewed The diagnostic test played a vitally important role during the COVID-19 pandemic, but controversy has followed in vitro diagnostics nonetheless. The...
FDA Closes EUA Program to Lab-Developed Tests
The question of whether the FDA has the authority to regulate lab-developed tests (LDTs) boiled into plain view in August when the Department of Health and Human Services directed the agency to...