The Food and Drug Administration (FDA) has announced that it will begin actively regulating tests developed in laboratories, with some exemptions. This decision comes after Congress failed to pass a law regulating these tests, which have grown in power and complexity over the years. The agency’s move is motivated by concerns about tests like Theranos’ faulty blood tests and misleading prenatal genetic tests, which have not been subject to FDA scrutiny in the past.
FDA Commissioner Robert Califf stated that the agency cannot allow Americans to rely on test results without assurance that they are accurate and reliable. The FDA’s decision is likely to face legal challenges, as these tests have historically been considered low-risk and outside of FDA regulation.
The regulation of laboratory-developed tests is a significant step for the FDA, as it marks a departure from its traditional approach to medical devices. The agency first started regulating medical devices in 1976 but has not previously extended this regulation to laboratory-developed tests. The increasing complexity and potential risks associated with these tests have prompted the FDA to take action.
It is important to note that some exemptions will apply to certain tests, but the FDA’s overall goal is to ensure that Americans can have confidence in the accuracy of the tests they rely on for medical decisions. The agency’s decision to regulate laboratory-developed tests reflects a broader trend towards increased oversight and scrutiny of the healthcare industry to protect consumers and ensure public safety.
While the FDA’s announcement is a significant development, it is likely to face legal challenges and pushback from stakeholders in the healthcare industry. However, the agency’s commitment to ensuring the safety and efficacy of medical tests is crucial for maintaining public trust in the healthcare system.
Overall, the FDA’s decision to regulate laboratory-developed tests represents a significant shift in the agency’s approach to medical devices and reflects the increasing complexity and potential risks associated with these tests. By actively regulating these tests, the FDA aims to protect consumers and ensure the accuracy and reliability of medical test results.
