FDA-2023-N-2177: Medical Devices: Laboratory Developed Tests Proposed Rule (Vol. LDTs are diagnostic tests that are not commercially distributed to other laboratories but, instead, are developed, validated and performed in-house by individual laboratories. However, we strongly believe that the FDA should not apply its device regulations to hospital and health system LDTs. Broad Scope of the RuleDifferentiating Hospital and Health System Clinical Laboratories from IVD Manufacturers. Even if this health system was able to qualify as a “small business,” the amount would still be almost $8 million — a substantial amount.

Source: New York Times December 02, 2023 04:28 UTC