Will the FDA Regulation of Lab-Developed Tests Affect In-Office Testing for Clinics
With the new U.S. Food and Drug Administration (FDA) regulations, Laboratory-Developed Tests (LDTs) are now classified as medical devices, bringing them under the same rigorous standards as commercial tests. This regulatory shift is expected to have substantial repercussions for in-office clinic testing, with profound implications for healthcare providers and patient care. The Impact on In-Office […]