(Docket No. FDA-2023-N-2177)
The proposed rule is designed to ensure that all diagnostic tests are accurate. It presents a strong case for the need for laboratory-developed test regulation and for FDA’s authority to regulate these tests. Further, the agency’s economic analysis of impacts demonstrates that the benefits of FDA regulation outweigh the costs. See comments supporting the proposed rule from CSPI and other consumer organizations as well as a supportive letter from patient groups.