The end of April, the start of new FDA regulations for clinical labs.
Laboratory developed tests (LDTs) will now be regulated as medical devices under the Federal Food, Drug, and Cosmetic Act. Here's some information from the FDA in bulleted format with links to pertinent information.
Brannon Hogue
8/24/20241 min read
As you probably have heard, laboratory developed tests (LDTs) will now be regulated as medical devices under the Federal Food, Drug, and Cosmetic Act.
Here's some information from the FDA in bulleted format with links to pertinent information.
There is going to be a 5 phase rollout,
Stage 1 (May 6, 2025): Expected compliance with medical device reporting requirements under 21 CFR Part 803, anything involving deaths, serious injuries, and malfunctions associated with LDTs should be reported. Expect compliance with correction and removal reporting requirements under 21 CFR Part 806, this means proper FDA reporting of any correction or removal of an LDT to reduce health risks or remedy violations. Expect compliance with quality system (QS) requirements regarding complaint files under 21 CFR 820.198, which requires establishing and maintaining complaint handling processes.
Stage 2 (May 6, 2026): Expect compliance with requirements not covered in other stages, such as: Establishment registration and device listing under 21 CFR Parts 607, 807 Subparts A-D, labeling requirements under 21 CFR Parts 801 and 809, and investigational use requirements under 21 CFR Part 812.
Stage 3 (May 6, 2027): Expect compliance with quality system requirements under 21 CFR Part 820 (other than complaint file requirements already addressed in Stage 1). For LDTs, the FDA generally will not expect compliance with QS requirements other than design controls, purchasing controls, acceptance activities, corrective and preventive action (CAPA), and records requirements.
Stage 4 (November 6, 2027): Expect compliance with premarket review requirements for high-risk LDTs ("high risk" meaning those that may be Class III devices or require licensure under the Public Health Service Act). If a premarket submission is received by this deadline, the FDA can exercise enforcement discretion during the review period.
Stage 5 (May 6, 2028): Expect compliance with requirements for moderate-risk and low-risk LDTs that require premarket submissions under 21 CFR Parts 807 Subpart E, 860 Subpart D, 814, and 601. Again, if a premarket submission is received by this deadline, the FDA can exercise enforcement discretion during the review period.