FDA Regulation of LDTs: Practical Tips and Considerations for Laboratories
After nearly half a century of enforcement discretion, the Food & Drug Administration (FDA) published its final rule on May 6, 2024, outlining a multi-year timeline to phase in the regulation of laboratory-developed tests (LDTs). Consequentially, laboratories that have historically offered LDTs without significant FDA oversight will begin to face FDA medical device regulatory requirements as soon as 2025.
Facing unprecedented regulatory oversight, all laboratories will want to begin understanding those aspects of medical device regulation that will apply and establish processes and procedures to support compliance with the agency’s regulatory scheme. Although the FDA has provided some regulatory flexibility that may help many currently marketed LDTs avoid FDA premarket review, the FDA is still imposing other device regulatory requirements on laboratories.
WEBINAR: LDT Regulations
ELIQUENT expert – Maura Norden – was a featured presenter at the Bass, Berry & Sims webinar addressing the FDA’s regulation of Laboratory Developed Tests.
The webinar, which provided an overview of the agency’s final rule, also addressed the following critical topics:
- The multi-stage approach adopted by the agency to transition LDTs into compliance with medical device regulations.
- The specific carve outs and other considerations that may, at least temporarily, shield LDT manufacturers from greater regulatory burdens.
- Requirements facing laboratories during the period of the agency’s phaseout policy, including practical tips to help laboratories to prepare the initial phases of FDA regulation.
Regulatory Resources.
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ELIQUENT’s unprecedented assembly of regulatory leaders, industry experts, and technical specialists partners with LDT companies to maintain compliance, ensure product quality, and remain competitive in an evolving regulatory landscape.
Learn more about ELIQUENT’s integrated LDT solutions and how our team of experts unlocks regulatory excellence:
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Ready for regulatory clarity? Contact us.
Regulatory Resources.
Unlock ELIQUENT Excellence.
View or download ELIQUENT QMSR Solutions Information Sheet to explore our integrated service offerings and learn how our team of experts unlocks regulatory excellence.
Info Sheet
View or download ELIQUENT’s QMSR Solutions Information Sheet to explore our integrated service offerings.
Full-Service Support
Learn more about ELIQUENT’s comprehensive Quality & Compliance Solutions.