Regulatory Landscape of Regenerative Dermatology: Current Frameworks and Future
January 2026 | Volume 25 | Issue 1 | 17 | Copyright © January 2026
Published online December 31, 2025
Rachel L. Ziebart MD MSa, Barbara Hernandez-Rovira BSb, Hema Sundaram MD MAc,d, Samantha Guhan MDe, Saranya P. Wyles MD PhDb
aMassachusetts General Hospital for Children, Boston, MA
bMayo Clinic Department of Dermatology, Rochester, MN
cPrivate Practice, Rockville, MD and Fairfax, VA
dUniversity of Manchester, School of Biological Sciences, Division of Musculoskeletal and Dermatological Sciences, United Kingdom
eNorthwestern University Department of Dermatology, Chicago, IL
Abstract
Background: 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.
Methods: 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.
Results: 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.
Discussion: 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.
Conclusion: 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.
INTRODUCTION
Standards in wellness and aesthetics have evolved over time, yet the desire to preserve youthful skin remains a universal priority shaped by biological and evolutionary factors.1 Regenerative dermatology is an emerging subspecialty that seeks to restore both the structure and function of healthy skin.2 Technological advances have broadened the field beyond primarily stem cell-based treatments to encompass a diverse array of acellular modalities, including extracellular vesicles or exosomes, peptides, and polynucleotides, driving both consumer interest and market expansion.3 Valued at approximately $30 billion USD globally in 2023, the regenerative medicine market is projected to surpass $90 billion over the next decade.4 As illustrated in Figure 1, regulatory frameworks for regenerative medicine vary significantly across countries. North America accounts for 58% of the global market4 and leads in the number of clinical trials in regenerative medicine3; yet the United States currently lacks comprehensive regulatory guidance for regenerative therapies. This review provides an overview of cellular and acellular therapies within regenerative dermatology and outlines the existing US regulatory pathways for approval of drugs, biologics, and medical devices in this rapidly evolving space.
MATERIALS AND METHODS
Articles on regenerative medicine and dermatology available in PubMed and regulatory guidelines issued by the US Food and Drug Administration (FDA) were synthesized to provide an overview of available therapies and the regulatory framework governing these products in the US Product classification and the nuances in regulatory standards specific to each category are discussed. Priority was given to articles and guidelines published between June 2020 and June 2025, with historical references included where appropriate for context. Results are described in narrative format.
