United States - Healthcare - LDTs: FDA Rolls Out A Phased Im

On May 6, 2024, the U.S. Food and Drug Administration issued its final rule significantly modifying FDA's approach to oversight of laboratory developed tests.

Related Keywords

United States , , Clinical Laboratory Improvement Act , Department Of Defense Or Veterans Health Administration , Health Care , Public Health Service , Clinical Laboratory Evaluation Program , York State Department Of Health , Development Act , Medicare Medicaid Services , Drug Administration , Laboratory Of Another Manufacturer , Public Health Surveillance , Enforcement Discretion , Cosmetic Act , Approach Since , Phased Implementation , Public Health Service Act , Human Leukocyte Antigen Tests , Law Enforcement , Veterans Health Administration , Rare Red Blood Cell , New York State Department , Marketed Prior , Final Rule , Unmet Needs , Labs Integrated , System Treating , Within Scope , Phaseout Policy , Screening Tests , Infectious Diseases , Certain Blood , Typing Tests , Medicaid Services ,