FDA Announces Regulation of Laboratory Developed Tests (LDTs) as Medical Devices

The U.S. Food and Drug Administration (FDA) announced a significant regulatory change regarding laboratory developed tests (LDTs), diagnostic products used within a single clinical laboratory. According to an article by Holland & Knight, these tests were regulated under the FDA’s discretion without strict enforcement of requirements like premarket clearance. However, recognizing increased risks associated with modern LDTs, the FDA will now regulate them as medical devices under a forthcoming final rule scheduled for May 6, 2024.

This shift subjects LDT manufacturers to various medical device regulations including premarket review, quality system standards, adverse event reporting, establishment registration, labeling, and investigational use requirements. The article states the FDA will implement a phased transition plan for currently marketed LDTs over several years:

• Stage 1 (from May 6, 2025): Compliance with medical device reporting, correction/removal reporting, and quality system requirements for complaint files.
• Stage 2 (from May 6, 2026): Compliance with remaining requirements not covered in Stage 1, including registration, listing, labeling, and investigational use requirements.
• Stage 3 (from May 6, 2027): Compliance with additional quality system requirements.
• Stage 4 (from Nov. 6, 2027): Compliance with premarket review requirements for high-risk LDTs, with continued enforcement discretion during review if a submission is received.
• Stage 5 (from May 6, 2028): Compliance with premarket review requirements for moderate and low-risk LDTs, with similar enforcement discretion if a submission is under review.

The FDA plans to provide further guidance and details on this transition and will host a webinar on May 14, 2024, to discuss the final rule and the phased transition policy.