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Disclaimer

Disclaimer

This page states plainly what this site is and is not. Read it alongside our compliance and quality pages before you request documentation or place an order.

Content is being prepared.

What this site does not provide

Nothing on this site is intended to diagnose, treat, cure, or prevent any disease or condition, and nothing here should be read as a claim that any product does so. These products are not FDA approved or licensed for any disease or condition.

Information on this site is for licensed healthcare professionals and is not medical advice, legal advice, or a substitute for your own regulatory counsel.

Regulatory status

FDA states that there are no FDA-approved exosome products. They are generally regulated as biologic drugs under section 351. Wharton's jelly products referenced on this site are offered under the supplier's human cell and tissue product framework; whether a specific intended use meets all applicable criteria in 21 CFR 1271.10 is a determination for your practice and your counsel, not a determination we make for you.

Purchase and clinical-use decisions for any product referenced on this site belong to the physician, working with their own regulatory counsel.