IVDs, LDTs, companion diagnostics — FDA & EU IVDR.
Representative work
Device classes & artefacts we support.
Class B Immunoassay analyzerNGS / lab automation analyzerDiagnostic instrumentationLDT test tubes
The problem
On May 6, 2024 the FDA released a final rule which added the words "including when the manufacturer of such products is a laboratory" to the definition of "in vitro diagnostic product" at 21 CFR 809.3 (a).
The FDA revised this final rule on March 31, 2025, with a U.S. District Court vacating the same and returning the wording back to what was present in the regulation before its effective date, on September 19, 2025.Most companies still have relaxed requirements against FDA and EU IVDR, both of which redefined the diagnostic industry standards, most laboratories do not currently comply with these regulations.
Our solution
We can create a Compliance strategy for FDA and EU IVDR regarding IVDs, LDTs, Next Generation Sequencing based Assays, Companion Diagnostics and Software-Only IVDs.
