Regulatory Advocacy Update: ASPS Comments in Response to the FDA Draft Guidance Documents on Human Cell and Tissue Products

Peter P. Rubin, Richard A. D’Amico, Ricardo Rodriguez, Sydney R. Coleman, Paul Cederna, Scot Glasberg, Michael Neumeister, David H. Song, Charles E. Butler, Keith M. Hume

Research output: Contribution to journalArticle

1 Scopus citations

Abstract

The Food and Drug Administration (FDA) released draft guidance documents on Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P) Regulations.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 This article describes the relevant issues in these draft guidance documents, and presents the comments provided to the FDA by the American Society of Plastic Surgeons (ASPS).

Original languageEnglish (US)
JournalPlastic and Reconstructive Surgery
DOIs
StateAccepted/In press - Feb 9 2017

ASJC Scopus subject areas

  • Surgery

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