Understanding the regulatory framework is crucial for providers integrating exosome therapies. Human Cell and Tissue Products (HCT/Ps) are categorized under two sections:
Section 361: Covers products that are minimally manipulated. Cosmetic use only, not regulated for use on broken skin.
Section 351(a): Pertains to products that are more than minimally manipulated. Regulated for systemic applications. These require rigorous evaluation and approval, ensuring safety and efficacy.
The FDA's Ruling On Regenerative Medicine Video
Unlike others, we chose the highest regulatory path
While any exosome company can choose to register under Section 351(a), we are the only one that has. This decision reflects our commitment to the highest standards of safety, transparency, and clinical integrity.
Why Section 351(a) Matters:
Stricter Regulatory Oversight – Products must meet biologic drug standards.
Clinical-Grade Quality – Manufactured under cGMP conditions.
Legal Use in Clinical Settings – Supports physician confidence and patient safety.
Science-Backed Assurance – Required 3rd party data on safety, purity, and potency.
351(a) vs 361 Pathway | Why it Matters
Microneedling | What You Need to Know
What Makes Post-Microneedling Use Risky
Microneedling creates micro-channels that allow deeper product penetration
This can:
Change route of administration (topical → subdermal/systemic)
Imply drug-like or therapeutic use
Violate regulatory 361 limits if:
1- Product isn't an approved drug/biologic
2- Purpose is regenerative or healing
Legal Use of regulatory 361 Products (HCT/P)
Permitted only for:
Homologous use (same function as source tissue)
Minimal manipulation
Topical cosmetic use on intact skin
Allowed only if:
Not marketed or used with therapeutic claims
Skin barrier is unbroken
Applying 361 products after microneedling is legally risky — it may exceed cosmetic use and expose providers to regulatory and legal consequences.
Legal Risks for Providers
Potential classification as unauthorized drug use
Exposure to:
Regulatory enforcement
Malpractice claims
State medical board actions
Safer Alternative – 351(a) Products (our MSC Exosomes)
Developed under current Good Manufacturing Practices (cGMP)
Has Drug Master File and investigational status
Intended for systemic/injected use
Supported by safety data and liability protection (Liability insurance policy that covers both the provider and patient—up to $20M per 5mL vial.)
Bottom Line
Don't proceed with any exosomes product until you understand this!
Revolutionizing Care With MSC Exosomes
Whether you're a patient exploring a regenerative path to healing or a provider looking to integrate a safe, compliant solution into your practice—you're in the right place.
Schedule a call below, and Seon Baptiste, our dedicated care coordinator, will personally reach out to answer your questions, provide expert guidance, and help you take the next step with confidence.
No pressure. Just clear answers, trusted support, and science-backed innovation.