Regulatory review boundaries
Whether a specific intended use meets criteria discussed under section 361 and 21 CFR 1271.10 is a determination for the clinic and its regulatory counsel.
This page is general information for licensed healthcare professionals. It is not medical or legal advice and does not establish a permitted application.
Documentation to request and file
Request the current insert, certificate of analysis format, donor eligibility summary approach, sterility testing description, and shipping instructions before the first purchase order.
At receipt, match lot ID, expiration, and shipper condition to the purchase order. Incomplete packs stay open—do not close them by assumption.
Exosome and adjacent-category caution
FDA has stated that no exosome product currently holds FDA approval and that products of this kind are generally regulated as biologic drugs. Do not assume 361 status from catalog adjacency.
Train staff so stem-cell search terms do not drive protocol or advertising language for exosome SKUs.
Procurement is not permission
Opening a verified account and receiving a shipment are procurement steps. They do not authorize a clinical application.
Keep procurement owners and counsel reviewers on separate tracks with written handoffs.
Frequently asked questions
Does Precision Biologics certify regulatory status for our use?+
No. Classification and intended-use determinations belong to the ordering physician and clinic counsel.
Is this legal advice?+
No. This is general information for licensed healthcare professionals.
Can account approval replace counsel review?+
No. Account verification is administrative only.
Does this page determine how we may use products discussed under section 361 HCT/P clinics?+
No. Intended use remains with the ordering physician and clinic counsel.