Medmarc Blog (blog.medmarc.com)
Medical Device Manufacturers
FDA’s QMSR Final Rule Now in Effect
The FDA’s Quality Management System Regulation (QMSR) is effective as of Feb. 2, 2026, two years after publication of the QMSR final rule. This new regulatory framework requires that manufacturers...
FDA’s Tightens Oversight of Cybersecurity in New Guidance
Recent security breaches at healthcare institutions have amplified the U.S. government’s concerns over cybersecurity, a fact reflected in the FDA’s most recent guidance on the subject. The June 2025...
AdvaMed Proposes Medtech MAHA in Response to Section 232 RFI
The U.S. Department of Commerce (DoC) has opened an investigation into the national security implications of trade relations for a variety of products, including medical devices. The Advanced...
H.R. 1 Restores Deductibility of Research and Development Expenses
Both chambers of the U.S. Congress have passed House Resolution 1 (H.R. 1), which offers several significant tax benefits for companies in the life sciences industry. One of the most important of...
AdvaMed Supportive of Three Bills for the MedTech Industry
Three bills have been introduced to Congress that may improve the prospects for manufacturers of medical devices, two of which would improve the outlook for the entire industry. The Advanced Medical...
AdvaMed Presses Senate on Urgency of Tariff Relief for Medical Devices
Tariffs placed on medical devices could impede patient access to these lifesaving products, an argument made by Scott Whitaker, President and CEO of the Advanced Medical Technology Association...
AdvaMed AI Roadmap Prods Washington to Keep Pace
The Advanced Medical Technology Association (AdvaMed) has published a policy roadmap for artificial intelligence (AI), identifying the tremendous benefits AI has to offer patients. However, AdvaMed...
Tariffs Again in Play as Trade Tensions Mount
The global trade picture for medical devices has become more complicated in the first weeks of 2025 as the U.S. has threatened to apply tariffs to a series of trading partners across the globe....
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...
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....