The U.S. Food and Drug Administration held a webinar on Dec. 3 to detail the registration and listing requirements for in vitro diagnostics (IVDs), including laboratory-developed tests (LDTs).
Within the FDA final rule regulating IVDs as medical devices under the Federal Food, Drug, & Cosmetics Act, a four-year phaseout policy of the agency’s general enforcement discretion approach to LDTs was implemented. Stage 2 of the phaseout policy requires compliance with establishment registration and listing requirements for most IVDs offered as LDTs beginning May 6, 2026.
The phaseout policy applies to IVDs manufactured as LDTs certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and meeting the regulatory requirements under CLIA to perform high complexity testing. Any laboratories that do not have LDTs under commercial distribution by May 6, 2026, must register and list the LDT within 30 days of beginning an activity or putting the LDT into commercial distribution. Establishments are also required to register annually, between Oct. 1 and Dec. 31 each year. Any updates are required to be provided within 30 days of the changes made.
Step-by-step instructions for creating online accounts for initial establishment registration, subsequent annual registration, and device listing can be found in the webinar slides, along with a list of policy product codes (beginning with slide 9).
For general information about or assistance with the registration or listing process, the FDA recommends emailing reglist@cdrh.fda.gov. For policy-specific questions about requirements for IVDs offered as LDTs, email LDTFinalRule@fda.hhs.gov.
The third FDA webinar in the LDT series, being held Jan. 9, will cover the steps to take to ensure compliance with the FDA requirements for corrective action and removal reporting specific to LDTs (stage 1). Registration for the upcoming webinar can be found here.
Source:
https://www.fda.gov/media/184208/download?attachment
