What this page is
A purchasing entry point for licensed clinics evaluating perinatal products often discussed in HCT/P terms.
It is not a determination that any SKU meets 21 CFR 1271.10 for your use.
What to request
Labeling, lot analysis, donor eligibility approach, sterility testing description, and shipping class for each SKU.
Exosome caution
Exosome products are generally discussed under biologic-drug frameworks; FDA has stated no exosome product currently holds FDA approval.
Do not assume 361 status from catalog placement.
Frequently asked questions
Will you certify our 361 pathway?+
No. That review belongs to your counsel.
Who can apply?+
Licensed clinics and physician-supervised practices.