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.
This webinar will provide the following:
- An overview of the agency’s final rule.
- 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.
This webinar will also specifically focus on explaining the 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.
To register, click here.
Questions?
Submit questions for presenters upon registration or email them to Caroline Smith.
Who Should Attend?
- Clinical laboratories and clinical laboratory professionals
- LDT manufacturers, attorneys and compliance personnel from laboratories
- Academic medical centers, health systems, and other entities historically offering laboratory testing
Accreditation
Tennessee CLE
This webinar is pending approval for one hour and fifteen minutes of General Tennessee CLE credit. Please provide your BPR number upon registration for Bass, Berry & Sims to report your participation to the Tennessee CLE Commission following the webinar.
Other State CLE
Bass, Berry & Sims does not seek direct accreditation from states outside of Tennessee, but some states allow attorneys to earn credit through reciprocity or self-submission. Certificates of completion and other common supporting documents will be provided for use in jurisdictions outside of Tennessee.