Webcast | Virtual
Event Title
Webinar - Final Rule: Medical Devices; Laboratory Developed Tests
May 14, 2024
- Date:
- May 14, 2024
- Time:
- 1:00 PM - 2:00 PM ET
Printable slides Presentation - FDA’s Final Rule Including a Phaseout Policy are currently available for this webinar. We intend to post the full presentation and transcript by Friday, May 24, 2024.
Summary
On May 14, 2024, the U.S. Food and Drug Administration (FDA) held a webinar to provide an overview of the Final Rule: Medical Devices; Laboratory Developed Tests.
During the webinar, the FDA:
- Provided an overview of the final rule amending the FDA's regulations to make it explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act including when the manufacturer of the IVD is a laboratory; and
- Described the phaseout of the FDA's general enforcement discretion approach to laboratory developed tests (LDTs).
Background
LDTs are in vitro diagnostic products (IVDs) that are intended for clinical use and are designed, manufactured, and used within a single laboratory that is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and meets the regulatory requirements under CLIA to perform high complexity testing. IVDs can play an important role in health care; they are used in the collection, preparation and examination of specimens taken from the human body, such as blood, saliva or tissue. They can be used to measure or detect substances or analytes, such as proteins, glucose, cholesterol or DNA, to provide information about a patient's health, including to identify, monitor or determine treatment for diseases and conditions.
On April 29, 2024, the U.S. Food and Drug Administration (FDA) announced a final rule amending the FDA's regulations to make explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. Along with this amendment, the FDA outlined a policy to phase out, over the course of four years, its general enforcement discretion approach to LDTs. The agency also outlined targeted enforcement discretion policies for certain categories of tests manufactured by laboratories.
The FDA considered the large volume of comments received to the notice of proposed rulemaking, and adjusted the phaseout policy in a manner that best serves the public health. The FDA believes that phasing out its general enforcement discretion approach for most LDTs, over a period of four years, will protect the public health by helping to assure the safety and effectiveness of these tests, while avoiding undue disruption to patient care. Additionally, increased compliance with device requirements under the FD&C Act (such as premarket review, quality system (QS) requirements, adverse event reporting, establishment registration and device listing, labeling requirements, and investigational use requirements) will put patients and health care providers in a better position to have confidence in IVDs regardless of where they are manufactured.
After this phaseout, the FDA generally will expect IVDs made by either a non-laboratory or laboratory to meet the same requirements, though certain IVDs manufactured by laboratories may fall within one of the agency's targeted enforcement discretion policies.
Webinar Materials
After the webinar, the presentation, printable slides, and transcript will be available at CDRH Learn under "In Vitro Diagnostics."
If you have questions about this final rule, please contact LDTFinalRule@fda.hhs.gov. If you have questions about this webinar, please contact CDRH's Division of Industry and Consumer Education (DICE) at dice@fda.hhs.gov, 1-800-638-2041, or 301-796-7100.