FDA

Introduction The FDA’s evolving stance on Laboratory Developed Tests (LDTs) has significant implications for clinical laboratories and reagent vendors. The recent FDA document outlines the need for increased regulatory oversight to ensure the safety and effectiveness of LDTs. However, this new role introduces risks to laboratory operations and the reagent vendors who have not yet […]

Introduction The FDA’s evolving stance on Laboratory Developed Tests (LDTs) has significant implications for clinical laboratories and reagent vendors. The recent FDA document outlines the need for increased regulatory oversight to ensure the safety and effectiveness of LDTs. However, this new role introduces risks to laboratory operations and the reagent vendors who have not yet

Introduction The FDA’s evolving stance on Laboratory Developed Tests (LDTs) has significant implications for clinical laboratories and reagent vendors. The recent FDA document outlines the need for increased regulatory oversight to ensure the safety and effectiveness of LDTs. However, this new role introduces risks to laboratory operations and the reagent vendors who have not yet

Introduction The FDA’s evolving stance on Laboratory Developed Tests (LDTs) has significant implications for clinical laboratories and reagent vendors. The recent FDA document outlines the need for increased regulatory oversight to ensure the safety and effectiveness of LDTs. However, this new role introduces risks to laboratory operations and the reagent vendors who have not yet

Introduction The FDA’s evolving stance on Laboratory Developed Tests (LDTs) has significant implications for clinical laboratories and reagent vendors. The recent FDA document outlines the need for increased regulatory oversight to ensure the safety and effectiveness of LDTs. However, this new role introduces risks to laboratory operations and the reagent vendors who have not yet

Introduction The FDA’s evolving stance on Laboratory Developed Tests (LDTs) has significant implications for clinical laboratories and reagent vendors. The recent FDA document outlines the need for increased regulatory oversight to ensure the safety and effectiveness of LDTs. However, this new role introduces risks to laboratory operations and the reagent vendors who have not yet

Introduction The FDA’s evolving stance on Laboratory Developed Tests (LDTs) has significant implications for clinical laboratories and reagent vendors. The recent FDA document outlines the need for increased regulatory oversight to ensure the safety and effectiveness of LDTs. However, this new role introduces risks to laboratory operations and the reagent vendors who have not yet

Introduction The FDA’s evolving stance on Laboratory Developed Tests (LDTs) has significant implications for clinical laboratories and reagent vendors. The recent FDA document outlines the need for increased regulatory oversight to ensure the safety and effectiveness of LDTs. However, this new role introduces risks to laboratory operations and the reagent vendors who have not yet

Introduction The FDA’s evolving stance on Laboratory Developed Tests (LDTs) has significant implications for clinical laboratories and reagent vendors. The recent FDA document outlines the need for increased regulatory oversight to ensure the safety and effectiveness of LDTs. However, this new role introduces risks to laboratory operations and the reagent vendors who have not yet