FDA LDT / IVD Compliance Timeline
A high-level look at how laboratory-developed tests are expected to align with in vitro diagnostic (IVD) device requirements—and where label content fits.
Where Labels Show Up in the Timeline
- Stage 2–3: Labeling content must align with registration, listing and QMS documentation.
- Stage 4–5: Premarket submissions for higher-risk tests include device labeling and IFUs.
- Ongoing: Post-market updates, adverse event reporting and CAPA can require label changes.
How We Support LDT & IVD Teams
- Standardized label templates linked to your QMS or document control system.
- Media and adhesives suitable for clinical, refrigerated and frozen use.
- Clear patient- and operator-facing information fields to match IFUs.