Lab Matters Winter 2024 | Page 29

POLICY

By Mandi Cosser , MPH , manager , Public Policy and Regulatory Affairs

Figure 1 . Enforcement Discretion Phaseout Policy

On May 6 , 2024 , the US Food and Drug Administration ( FDA ) published the Final Rule : Medical Devices ; Laboratory Developed Tests ( LDTs ). The rule made it explicit that in vitro diagnostic devices ( IVDs ) are medical devices subject to regulation under the Food , Drug and Cosmetic Act , including when the manufacturer of the test is a laboratory . These IVDs include LDTs developed and used in-house at public health laboratories . This means public health laboratories are considered manufacturers when they implement an LDT .

APHL is taking multiple actions to support members in implementing the requirements of the Final Rule . The APHL Board of Directors approved the formation of the LDT Task Force , which will advise APHL where clarification and support is needed . Comprised of APHL

APHL has developed a specific mailbox , LDTquestions @ aphl . org , for member requests for information .

members and staff representing program areas affected by the Final Rule , the Task Force will suggest and prioritize materials for development to assist with member compliance , identify where clarification is needed from FDA , and contribute to APHL ’ s comments on future FDA draft guidance . This is an important function of the group as FDA will continue to provide information on meeting Final Rule requirements and will be looking for examples for their documents . APHL will inform FDA of member feedback , sharing specific examples that can be used in future FDA materials .

Enforcement Discretion and LDTs

For many years , FDA had chosen to exercise enforcement discretion for LDTs and not require public health laboratories to submit packages to FDA for review and approval prior to marketing ( offering ) the test . The agency maintains they have always had the authority to regulate LDTs , but they had generally chosen not to . The era of general enforcement discretion for LDTs ends with the release of the Final Rule .

APHL understands public health laboratories utilize LDTs for many reasons — to promote health equity , prevent the spread of disease , conduct surveillance , develop disease treatment and prevention guidelines and respond to public health emergencies — and that members implement them to meet