On 6 May 2024 FDA published a final rule making explicit that in vitro diagnostic products are devices under the Federal Food, Drug, and Cosmetic Act even when manufactured by a laboratory, and setting out a four-year phase-out of the general enforcement discretion for laboratory developed tests (LDTs).
The phase-out stages
- Stage 1 (May 2025): medical device reporting, correction and removal reporting, and complaint files.
- Stage 2 (May 2026): registration and listing, labelling, and investigational use requirements.
- Stage 3 (May 2027): quality system requirements.
- Stages 4 and 5 (November 2027 and May 2028): premarket review for high-risk, then moderate-risk tests.
What laboratories started doing
Clinical laboratories began inventories of their LDTs, risk classification, and gap assessments against quality system and premarket requirements. Several carved out tests that fell under continued enforcement discretion categories. Vakula supported laboratories with regulatory and quality consultants during 2024. Note: this rule was later vacated by a federal court; see our 2025 update.