AHA to Congress: FDA proposal to regulate laboratory developed tests overreaches 

The Food and Drug Administration’s proposal to regulate laboratory developed tests would undermine innovation and reduce access to effective and appropriate care for patients, AHA March 21 told the House Energy and Commerce Subcommittee on Health.

“While we support the need for additional oversight of the development and use of some LDTs and in-vitro diagnostics offered as LDTs, the FDA’s proposal to apply its device regulations to hospital and health system LDTs is misguided,” AHA said in a statement submitted for a hearing on the proposed rule. “These tests are not devices — they are diagnostic tools developed and used for essential patient care. Regulating LDTs under the FDA’s device regulatory framework could cause patients to lose access to many critical tests and stifle innovative advances in hospital and health system laboratory medicine.”