| Web: | mayocliniclabs.com |
|---|---|
| Email: | mcl@mayo.edu |
| Telephone: | 800-533-1710 |
| International: | +1 855-379-3115 |
| Values are valid only on day of printing | |
| Web: | mayocliniclabs.com |
|---|---|
| Email: | mcl@mayo.edu |
| Telephone: | 800-533-1710 |
| International: | +1 855-379-3115 |
| Values are valid only on day of printing | |
This webinar will provide a brief history of the FDA’s interest in laboratory-developed tests (LDTs) and review the new requirements in detail, serving as an introduction to medical device regulations in the context of a clinical laboratory.
In October 2023, the FDA proposed new regulations that declare LDTs to be medical devices, subject to oversight by the FDA. The regulations were finalized in the spring of 2024. FDA envisions a multi-year phase-in period, with new requirements going into effect at certain milestones, including adverse event reporting, laboratories registering as medical device manufacturers and listing information about their tests in a public database, new quality system requirements, and ultimately submission of test validation information to the FDA. Laboratories that do not meet these requirements will not be allowed to maintain existing LDTs or develop new ones. The impact on the diagnostic testing landscape is enormous.
Shannon Bennett, M.S., M.B.A., CMQOE (ASQ)
Director, Regulatory Affairs
Department of Laboratory Medicine and Pathology
Mayo Clinic
Rochester, Minnesota
Matthew Binnicker, Ph.D.
Professor of Laboratory Medicine and Pathology
Division of Clinical Microbiology
Mayo Clinic
Rochester, Minnesota
Upon completion of this activity, participants should be able to:
This webinar is appropriate for laboratory leaders, healthcare providers, and other laboratory personnel who are interested in innovations and the future direction of lab medicine.
The following types of credit are offered for this event:
Mayo Clinic Laboratories is approved as a provider of continuing education programs in the Clinical Laboratory Sciences by the ASCLS P.A.C.E.® program. This program has been approved for a maximum of 1.0 P.A.C.E.® contact hour.
Mayo Clinic Laboratories is approved as a Continuing Education Accrediting Agency for the Clinical Laboratory Sciences for the State of Florida. Florida Board of Clinical Laboratory Personnel has designated this program for Supervision/Administration, Quality Control/Quality Assurance, and Safety credit. This program has been approved for 1.0 contact hour.
1. Watch the video.
2. Complete the posttest and evaluation that launches immediately following the video.
3. Generate and print your certificate(s).
Level of instruction for this program is basic.
Credit for this recording expires on June 13, 2026.
Course director(s), planning committee, faculty, and all others who are in a position to control the content of this educational activity are required to disclose all relevant financial relationships with any commercial interest related to the subject matter of the educational activity. Safeguards against commercial bias have been put in place. Faculty members also will disclose any off-label and/or investigational use of pharmaceuticals or instruments discussed in their presentations. Disclosure of this information will be published in course materials so those participants in the activity may formulate their own judgments regarding the presentations.
Contact us: mcleducation@mayo.edu
