Regulatory Considerations of Orthobiologic Procedures

Kudo Jang; William A Berrigan; Ken Mautner

doi:10.1016/j.pmr.2022.08.016

Regulatory Considerations of Orthobiologic Procedures

Phys Med Rehabil Clin N Am. 2023 Feb;34(1):275-283. doi: 10.1016/j.pmr.2022.08.016. Epub 2022 Oct 17.

Authors

Kudo Jang¹, William A Berrigan², Ken Mautner³

Affiliations

¹ Department of Physical Medicine and Rehabilitation, Emory University School of Medicine, Atlanta, GA, USA.
² Department of Orthopaedics, University of California San Francisco, CA, USA. Electronic address: https://twitter.com/@WBerriganMD.
³ Department of Physical Medicine and Rehabilitation, Emory University School of Medicine, Atlanta, GA, USA; Department of Orthopedics, Emory University School of Medicine, Atlanta, GA, USA. Electronic address: kmautne@emory.edu.

PMID: 36410887
DOI: 10.1016/j.pmr.2022.08.016

Abstract

The injection of biologic products for musculoskeletal pathologies is an emerging and promising field; however, dubious and unsafe uses for these products are often marketed. The Food and Drug Administration (FDA) has determined the need for varying degrees of regulation for these products for safety and efficacy. These regulations are frequently updated and federally enforced. As the regulatory landscape changes, clinicians using biologic products must stay informed to remain within the purview of the FDA. This article describes the current regulations of the most common products: platelet-rich plasma, bone marrow aspirate concentrate, adipose-derived products, and birth tissue products.

Keywords: BMAC; Birth tissue products; FDA; MFAT; PRP; SVF.

Publication types

Review

MeSH terms

Biological Products*
Humans
Injections
Platelet-Rich Plasma*

Substances

Biological Products