Concise Review: The U.S. Food and Drug Administration and Regenerative Medicine

• Published in: Stem cells translational medicine 2015-12, Vol.4 (12), p.1495-1499
• Main Authors: Witten, Celia M., McFarland, Richard D., Simek, Stephanie L.
• Format: Article
• Language: English
• Subjects: Cell Engineering - legislation & jurisprudence; Cell Engineering - methods; Cell Engineering - standards; Corporate sponsorship; Government agencies; Humans; Innovations; Jurisdiction; Manufacturing; Medical equipment; Medicine; Product development; Regenerative medicine; Regenerative Medicine - legislation & jurisprudence; Regenerative Medicine - methods; Regenerative Medicine - standards; Regulated industries; Regulation; Science; Stem cells; Tissue engineering; Tissue Engineering and Regenerative Medicine; U.S. Food and Drug Administration; United States; United States Food and Drug Administration; Workshops
• ISSN: 2157-6564; 2157-6580
• DOI: 10.5966/sctm.2015-0098

Regenerative medicine products regulated by the US Food and Drug Administration (FDA) are classified on the basis of formal regulatory definitions for biologics, medical devices, and combination products, as well as human cells and tissues. FDA efforts to facilitate product development in this promising area for unmet needs include working with individual sponsors, interacting with the scientific and industry communities, participating in standards development, and developing policy and guidance. Regenerative medicine (RM) is a popular term for a field of scientific and medical research. There is not one universally accepted definition of RM, but it is generally taken to mean the translation of multidisciplinary biology and engineering science into therapeutic approaches to regenerate, replace, or repair tissues and organs. RM products have the potential to provide treatments for a number of unmet needs but have substantial scientific and regulatory challenges that need to be addressed for this potential to be fully realized. FDA has established formal regulatory definitions for biologics, medical devices, and combination products, as well as human cells and tissues. Regenerative medicine products regulated by FDA are classified on the basis of these definitions, and the classification forms the basis for determining the regulatory requirements to each specific product. FDA regulations are generally written to allow the agency flexibility to accommodate new scientific questions raised by novel and evolving technologies. FDA efforts to facilitate product development in this novel and promising area include working with individual sponsors, interacting with the scientific and industry communities, participating in standards development, and developing policy and guidance. Significance Regenerative medicine is generally taken to mean the translation of multidisciplinary biology and engineering science into therapeutic approaches to regenerate, replace, or repair tissues and organs. This article provides an overview of the efforts of the U.S. Food and Drug Administration (FDA) to facilitate product development in the field commonly known was regenerative medicine. It provides an introduction to the processes by which FDA works with individual sponsors, interacts with the scientific and industry communities, participates in standards development, and develops formal FDA policy and guidance.