Recently, the FDA clarified regulation around the importation of biological specimens used in clinical laboratory testing or basic scientific research. This update helps simplify what does — and does not — fall under FDA regulation.
What’s not FDA-regulated
The FDA confirmed that certain specimens are not considered biological products, drugs, or devices when they are imported strictly for testing or research. These include:
• Urine, stool, tissue slides, blood, plasma, serum, or biopsies
These items are not used for prevention, treatment, diagnosis, or cure, so they do not fall under FDA jurisdiction when imported for research or lab testing purposes.
Documentation requirements
Importers should ensure all shipping documents and labels clearly identify:
• The contents
• The intended use (testing or research only)
• A statement confirming the specimens are not regulated by FDA
Providing this information upfront helps reduce clearance delays.
When FDA rules do apply
If the specimens will be used to manufacture or process human cells, tissues, or cellular/tissue-based products (HCT/Ps), or if they are intended for use in drugs, biological products, or devices, then full FDA requirements apply.
You can read the full announcement here.
For general FDA import operations or policy questions, the agency recommends reaching out to Imports@fda.hhs.gov.
