On April 29, the FDA released a final rule to gradually phase out its long-standing policy of enforcement discretion for laboratory developed tests (LDTs) practically applying the same enforcement approach as in-vitro diagnostics.
The rule will become effective on July 5, 2024 but the FDA will phase out its longstanding practice of enforcement discretion for LDTs with a five-stage policy until 2028, which is illustrated in Evnia’s presentation here: FDA’s LDT PhaseOut Policy!
Remember
📌𝐆𝐫𝐚𝐧𝐝𝐟𝐚𝐭𝐡𝐞𝐫𝐢𝐧𝐠 𝐂𝐥𝐚𝐮𝐬𝐞: FDA intends to exercise enforcement discretion and generally not enforce premarket review and quality system requirements (except for requirements under part 820, subpart M (Records)) 𝐟𝐨𝐫 𝐜𝐮𝐫𝐫𝐞𝐧𝐭𝐥𝐲 𝐦𝐚𝐫𝐤𝐞𝐭𝐞𝐝 𝐈𝐕𝐃𝐬 𝐨𝐟𝐟𝐞𝐫𝐞𝐝 𝐚𝐬 𝐋𝐃𝐓𝐬 𝐭𝐡𝐚𝐭 𝐰𝐞𝐫𝐞 𝐟𝐢𝐫𝐬𝐭 𝐦𝐚𝐫𝐤𝐞𝐭𝐞𝐝 𝐩𝐫𝐢𝐨𝐫 𝐭𝐨 𝐭𝐡𝐞 𝐝𝐚𝐭𝐞 𝐨𝐟 𝐢𝐬𝐬𝐮𝐚𝐧𝐜𝐞 𝐨𝐟 𝐭𝐡𝐢𝐬 𝐫𝐮𝐥𝐞. Yet, as a counterbalance, the FDA will be at liberty to determine whether LDTs on market have adequate validation and performance, via 21 CFR 807.26(e).
📌 𝐍𝐘𝐒 𝐂𝐋𝐄𝐏 𝐏𝐫𝐨𝐯𝐢𝐬𝐢𝐨𝐧: FDA intends to exercise enforcement discretion and generally not enforce premarket review requirements for LDTs approved by NYS CLEP (tests validated by the New York State Clinical Laboratory Evaluation Program).
📌 Integrated Laboratories: FDA intends to exercise enforcement discretion and generally not enforce premarket review requirements and QS requirements (except for requirements under part 820, subpart M (Records)) 𝐟𝐨𝐫 𝐋𝐃𝐓𝐬 𝐦𝐚𝐧𝐮𝐟𝐚𝐜𝐭𝐮𝐫𝐞𝐝 𝐚𝐧𝐝 𝐩𝐞𝐫𝐟𝐨𝐫𝐦𝐞𝐝 𝐛𝐲 𝐚 𝐥𝐚𝐛𝐨𝐫𝐚𝐭𝐨𝐫𝐲 𝐢𝐧𝐭𝐞𝐠𝐫𝐚𝐭𝐞𝐝 𝐰𝐢𝐭𝐡𝐢𝐧 𝐚 𝐡𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐬𝐲𝐬𝐭𝐞𝐦 𝐭𝐨 𝐦𝐞𝐞𝐭 𝐚𝐧 𝐮𝐧𝐦𝐞𝐭 𝐧𝐞𝐞𝐝 𝐨𝐟 𝐩𝐚𝐭𝐢𝐞𝐧𝐭𝐬 𝐫𝐞𝐜𝐞𝐢𝐯𝐢𝐧𝐠 𝐜𝐚𝐫𝐞 𝐰𝐢𝐭𝐡𝐢𝐧 𝐭𝐡𝐞 𝐬𝐚𝐦𝐞 𝐡𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐬𝐲𝐬𝐭𝐞𝐦.
