Regulatory Landscape of Regenerative Dermatology: Current Frameworks and Future

Regenerative dermatology is an emerging subspecialty that seeks to restore the structure and function of healthy skin. The United States lacks comprehensive regulatory guidance for regenerative therapies. This review provides an overview of available therapies within regenerative dermatology, outlining the pathways for approval.

Articles on regenerative dermatology in PubMed and guidelines issued by the United States Food and Drug Administration (FDA) were reviewed with emphasis on those published between June 2020 and June 2025, and results were summarized in narrative format.

In the United States, the FDA is the primary regulatory authority responsible for ensuring the safety and efficacy of regenerative biotherapeutics. Classification of a product as a drug, biologic, device, or cosmetic determines the regulatory pathway it must follow.

Cosmetics are intended to promote attractiveness without treating or preventing disease and do not require FDA approval prior to marketing, while drugs and biologics undergo a multi-step process to obtain approval: (1) product development, (2) preclinical testing in a laboratory setting, (3) clinical trials involving human subjects, (4) FDA review, and (5) FDA approval. High-risk devices require a Premarket Approval (PMA), while low-to-moderate risk devices have less stringent requirements.

Regenerative dermatology offers significant therapeutic potential. Regulation is governed by the US FDA and varies according to product classification. Clinicians should counsel patients on safety and efficacy data prior to initiating regenerative treatments.  .