AdvaMed Launches New Digital Health Tech Division, Appoints Board Members

WASHINGTON, D.C. – Today, AdvaMed, the Medtech Association, announced the formation of AdvaMed Digital Health Tech, a new division within the organization that represents digital medical technology companies and promotes the critical role of data and digital medtech in transforming health care. The group, which is led by Shaye Mandle, acts as a thought leader and convener for the industry and focuses on four core policy areas: regulation, payment and health care delivery, data stewardship and privacy, and cybersecurity.

Continue reading

Special Report: FDA’s proposed rule to bring LDTs into the fold

After bringing up the topic many times over the past two decades, the FDA has finally done it: They’ve issued a proposed rule that would eliminate the agency’s enforcement discretion over laboratory-developed tests (LDTs), integrating LDTs into the FDA’s oversight over a period of four years. This issue has been top of mind for the FDA and most everyone in the diagnostics ecosystem for many years. The change has the potential to be a very big deal. Whether for good or bad depends on your viewpoint.Continue reading

ACLA Opposes Unilateral FDA Action to Regulate Laboratory Developed Tests Under Medical Device Authority

September 29, 2023 

Washington, D.C. – The American Clinical Laboratory Association (ACLA) today issued the following statement after the U.S. Food and Drug Administration (FDA) released a proposed rule that would seek to regulate Laboratory Developed Tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act. ACLA does not believe that FDA’s actions are in the best interest of patients or our nation’s health care system. Because the proposed rule exceeds FDA’s existing authority, ACLA plans to submit comments urging FDA to withdraw the proposed rule and resume work with Congress, the laboratory community, patient groups, and other stakeholders toward a legislative solution that provides a framework that is appropriate for the unique attributes of LDTs.Continue reading