Regulatory Advocacy Update: American Society of Plastic Surgeons Comments in Response to the U.S. Food and Drug Administration Draft Guidance Documents on Human Cell and Tissue Products

J Peter Rubin; Richard A D'Amico; Ricardo Rodriguez; Sydney R Coleman; Paul Cederna; Scot Glasberg; Michael Neumeister; David H Song; Charles Butler; Keith M Hume

doi:10.1097/PRS.0000000000003240

Regulatory Advocacy Update: American Society of Plastic Surgeons Comments in Response to the U.S. Food and Drug Administration Draft Guidance Documents on Human Cell and Tissue Products

Plast Reconstr Surg. 2017 May;139(5):1259-1261. doi: 10.1097/PRS.0000000000003240.

Authors

J Peter Rubin^{1

2}, Richard A D'Amico^{1

2}, Ricardo Rodriguez^{1

2}, Sydney R Coleman^{1

2}, Paul Cederna^{1

2}, Scot Glasberg^{1

2}, Michael Neumeister^{1

2}, David H Song^{1

2}, Charles Butler^{1

2}, Keith M Hume^{1

2}

Affiliations

¹ Pittsburgh, Pa.; Englewood, N.J.; New York, N.Y.; Baltimore, Md.; Ann Arbor, Mich.; Chicago, Ill.; Washington, D.C.; and Houston, Texas.
² From the Department of Plastic Surgery, University of Pittsburgh; private practice; the Department of Plastic Surgery, Hansjörg Wyss Department of Plastic Surgery, New York University; the Section of Plastic Surgery, Department of Surgery, University of Michigan; the Department of Plastic Surgery, Georgetown University; and the Department of Plastic Surgery, the University of Texas, M. D. Anderson Cancer Center.

PMID: 28445381
DOI: 10.1097/PRS.0000000000003240

Abstract

The U.S. Food and Drug Administration released draft guidance documents on human cells, tissues, and cellular and tissue-based products regulations. These proposed guidance documents can impact the practice of plastic surgery in the area of tissue grafting procedures. This article describes the relevant issues in these draft guidance documents, and presents the comments provided to the U.S. Food and Drug Administration by the American Society of Plastic Surgeons.

MeSH terms

Cell- and Tissue-Based Therapy / standards*
Humans
Plastic Surgery Procedures / standards*
Practice Guidelines as Topic*
Societies, Medical*
Surgery, Plastic / standards*
United States
United States Food and Drug Administration*