FDA’s Latest Push to Regulate LDTs as Medical Devices
This Bulletin is brought to you by AHLA’s Life Sciences Practice Group.
- October 24, 2023
- Elaine Naughton , Bass Berry & Sims PLC
- Heather Pearson , Bass Berry & Sims PLC
In its most definitive step yet to regulate laboratory-developed tests (LDTs) as medical devices, the U.S. Food & Drug Administration (FDA) published an anticipated proposed rule (Proposed Rule) on October 3, 2023, outlining its intention to: (1) clarify that in vitro diagnostic products (IVDs) are medical devices regardless of where manufactured, and, (2) phase out the agency’s historic policy of regulatory enforcement discretion that has long spared LDTs from FDA oversight. This Proposed Rule marks the agency’s latest formal attempt to regulate LDTs since its abandoned 2014 Draft Guidance.
ARTICLE TAGS
You must be logged in to access this content.