FDAFinal Rule
Medical Devices; Laboratory Developed Tests; Phased Oversight Framework
HealthcareTechnology
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Summary
This final rule phases out the FDA's longstanding enforcement discretion for laboratory developed tests (LDTs) and brings them under the same regulatory framework as other in vitro diagnostics. The rule implements a four-year phaseout period, beginning with adverse event reporting requirements and culminating in full premarket review for high-risk tests.
Key Points
- 1Ends general enforcement discretion for laboratory developed tests over a four-year period
- 2Phase 1 requires medical device reporting and correction/removal reporting within one year
- 3Phase 2 requires registration, listing, and labeling requirements within two years
- 4Phase 3 requires quality system compliance within three years
- 5High-risk LDTs will require premarket authorization or approval by year four
Key Dates
Published
May 6, 2024
Effective
May 6, 2025
This summary is for informational purposes only. It may not capture all nuances of the regulation. Always refer to the official text for authoritative information.
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