Rubin J Peter, D'Amico Richard A, Rodriguez Ricardo, Coleman Sydney R, Cederna Paul, Glasberg Scot, Neumeister Michael, Song David H, Butler Charles, Hume Keith M
Pittsburgh, Pa.; Englewood, N.J.; New York, N.Y.; Baltimore, Md.; Ann Arbor, Mich.; Chicago, Ill.; Washington, D.C.; and Houston, Texas.
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.
Plast Reconstr Surg. 2017 May;139(5):1259-1261. doi: 10.1097/PRS.0000000000003240.
The U.S. Food and Drug Administration released draft guidance documents on human cells, tissues, and cellular and tissue-based products regulations.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 This article describes the relevant issues in these draft guidance documents, and presents the comments provided to the U.S. Food and Drug Administration by the American Society of Plastic Surgeons.
美国食品药品监督管理局发布了关于人类细胞、组织以及基于细胞和组织的产品法规的指导文件草案。这些拟议的指导文件可能会影响组织移植手术领域的整形外科学实践。本文描述了这些指导文件草案中的相关问题，并呈现了美国整形外科医师协会向美国食品药品监督管理局提供的意见。
