Regulatory posture for exosome and Wharton's jelly products
The FDA has stated that there are no FDA-approved exosome products; exosome products are generally regulated as biologic drugs under section 351 of the PHS Act. Wharton's jelly products are offered under the supplier's HCT/P framework, and whether a specific intended use qualifies under 21 CFR 1271.10 is a determination for the practice and its own counsel.
Precision Biologics does not advise on clinical use, dosing, or protocols for either product family. Pain management and physical medicine groups are encouraged to route these questions to their medical director and legal counsel.
Merced
NPPES registry listings, primary taxonomy, retrieved 2026-10-27
8- Pain Medicine
- 3
- Physical Medicine & Rehabilitation
- 5
Documentation a pain management group should request
Before adding a supplier to an approved list, pain management and physical medicine practices typically request a certificate of analysis, a donor eligibility summary, and a lot release record for the lot under consideration.
Precision Biologics provides this documentation, along with supplier-reported characterization data for exosome products, to verified accounts on request.
- Certificate of analysis
- Donor eligibility summary
- Lot release record
- Supplier characterization data (exosome products)
NPI-verified accounts and ordering
Ordering is limited to accounts verified against an NPI number in the NPPES registry. This keeps purchasing restricted to licensed professionals practicing at a specific facility.
Setting up an account takes a short submission of NPI and facility information; pricing is released only once the account is verified.
Shipping cold-chain and shelf-stable formats to the West region
Cryopreserved Wharton's jelly formats ship overnight on dry ice at -80 degrees Celsius in validated containers; lyophilized formats are shelf-stable and do not require cryogenic storage, per the supplier's handling instructions included with each lot.
Every lot carries a unique identifier so the receiving practice can track use at the patient record level, regardless of which format is ordered.
These products are not FDA approved or licensed for any disease or condition. Information is for licensed healthcare professionals and is not medical or legal advice.
Frequently asked questions
Does Precision Biologics sell exosome products as an approved treatment for pain conditions?+
No. There are no FDA-approved exosome products. Precision Biologics distributes documentation and product; purchase and clinical-use decisions, including whether any product fits a specific use, belong to the physician and their own regulatory counsel.
How does a pain management practice in Merced set up an ordering account?+
Submit your NPI and facility information for verification against the NPPES registry. Once verified, your account can view documentation and pricing.
What should our medical director review before we add this supplier?+
Have your medical director and counsel review the certificate of analysis, donor eligibility summary, lot release record, and, for exosome products, the supplier's characterization data, alongside your own regulatory posture under 21 CFR 1271.10.