by Chad Brueck | Mar 22, 2024 | MDC Blog
In the rapidly evolving world of in vitro Diagnostic (IVD) devices, staying abreast of regulatory changes is crucial. We’re committed to keeping you informed about these developments so be sure to subscribe for our IVDwise updates or check back often. A recent...
by Chad Brueck | Feb 20, 2024 | MDC Blog
January 2024 CLSI Committees Week CLSI committees convene multiple times annually to discuss emerging protocols, evolving practices, and the formulation of novel standards within the realm of laboratory medicine. We recently had the opportunity to attend the Clinical...
by Chad Brueck | Jan 30, 2024 | MDC Blog
To ensure the availability of essential healthcare products, the European Commission has proposed an extension for companies to comply with the In Vitro Diagnostic Medical Devices Regulation (IVDR). This regulation, implemented in May 2022, seeks to modernize and...
by Chad Brueck | Jan 23, 2024 | MDC Blog
At a glance — The FDA and CMS issued a joint statement regarding the FDA’s proposed rule concerning LDTs on January 18, 2023. Both agencies rejected the notion that an expansion of CLIA was an option to address concerns with current oversight of LDTs. On...
by Chad Brueck | Jan 11, 2024 | MDC Blog
The U.S. Food and Drug Administration (FDA) recently proposed regulations for Laboratory Developed Tests (LDTs), sparking intense debate among key healthcare and diagnostic testing stakeholders. As experts in guiding In Vitro Diagnostics (IVDs) and Medical Devices...
by Chad Brueck | Oct 31, 2023 | MDC Blog
The U.S. Food and Drug Administration (FDA) recently issued updates to the final guidance on the Breakthrough Devices Program. In the dynamic world of healthcare and medical technology, innovation and progress have always been at the forefront. The quest to improve...
