Medmarc Blog (blog.medmarc.com)
Medical Device (3)
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...
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...
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...
FDA Provides Greater Possibilities for Real-World Evidence
In 2023, the FDA prioritized the use of real-world evidence (RWE) for regulatory decision making for medical products, leading to the development of two guidance’s. In both cases, the FDA was...
Regulatory Partners Release guidelines for PCCPs
The FDA and two other national regulatory agencies have collaborated on a set of guiding principles for predetermined change control plans, or PCCPs, which are applicable to machine learning-enabled...
FDA Guidance Promises Closer Scrutiny of Medical Device Cybersecurity
The FDA’s most recent final guidance for medical device cybersecurity represents a significant shift in the agency’s perspectives regarding cybersecurity, which is part of a broader emphasis on...
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...