Abstract
Regulatory agencies vary widely in their classification of FMT, with significant impact on patient access. This article conducts a global survey of national regulations and collates existing FMT classification statuses, ultimately suggesting that the human cell and tissue product designation best fits FMT's characteristics and that definitional objectives to that classification may be overcome.
Publisher
Cambridge University Press (CUP)
Subject
Health Policy,General Medicine,Issues, ethics and legal aspects
Reference126 articles.
1. Faecal microbiota transplantation: A sui generis biological drug, not a tissue
2. Fecal Microbiota Transplantation for Clostridium difficile Infection: Systematic Review and Meta-Analysis
3. 92. Garcia de Paredes, A.G. et al., “Trasplante de Microbiota Fecal por Colonoscopia para el Tratamiento de la Infección Recurrente por Clostridium difficile,” Asociación Española de Gastroenterología (2019).
4. 63. Competent Authorities on Substances of Human Origin Expert Group, Meeting of the Competent Authorities for Tissues and Cells Summary Report, June 2014.
5. Fecal Microbiota Transplantation: A Practical Update for the Infectious Disease Specialist
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