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@article{1846921,
author = {Potočková, Hana and Dohnal, Jiří and ThomeandKromer, B.},
article_location = {Paris},
article_number = {3},
doi = {http://dx.doi.org/10.20506/rst.39.3.3171},
keywords = {European Union; Japan; Point-of-care testing; Regulation; United States of America; Veterinary diagnostics},
language = {eng},
issn = {0253-1933},
journal = {REVUE SCIENTIFIQUE ET TECHNIQUE-OFFICE INTERNATIONAL DES EPIZOOTIES},
title = {Regulation of veterinary point-of-care testing in the European Union, the United States of America and Japan},
url = {https://doc.oie.int/dyn/portal/index.xhtml?page=alo&aloId=42232},
volume = {39},
year = {2020}
}
TY - JOUR
ID - 1846921
AU - Potočková, Hana - Dohnal, Jiří - Thome-Kromer, B.
PY - 2020
TI - Regulation of veterinary point-of-care testing in the European Union, the United States of America and Japan
JF - REVUE SCIENTIFIQUE ET TECHNIQUE-OFFICE INTERNATIONAL DES EPIZOOTIES
VL - 39
IS - 3
SP - 699-709
EP - 699-709
PB - OFFICE INT EPIZOOTIES
SN - 02531933
KW - European Union
KW - Japan
KW - Point-of-care testing
KW - Regulation
KW - United States of America
KW - Veterinary diagnostics
UR - https://doc.oie.int/dyn/portal/index.xhtml?page=alo&aloId=42232
N2 - Point-of-care testing (POCT) is used to detect diseases and other conditions or to monitor therapeutic procedures. In veterinary medicine, POCT not only helps during the prevention, diagnosis and treatment of animal diseases but it also has a direct impact on human health by safeguarding food supplies and preventing zoonoses. Despite its importance, the regulation of the quality, safety and effectiveness of POCT products is rarely discussed. This review reveals that the level of regulatory surveillance of veterinary POCT products in the European Union (EU), the United States of America and Japan is strikingly different, ranging from no regulation (EU) to comprehensive regulation, which is comparable to the procedures for the regulation of human in vitro medical devices (Japan). Details about the licensing procedures in these three locations, discussion of their strengths and weaknesses, and suggestions for possible future development of the regulation of these products are also provided.
ER -
POTOČKOVÁ, Hana, Jiří DOHNAL and B. THOME-KROMER. Regulation of veterinary point-of-care testing in the European Union, the United States of America and Japan. \textit{REVUE SCIENTIFIQUE ET TECHNIQUE-OFFICE INTERNATIONAL DES EPIZOOTIES}. Paris: OFFICE INT EPIZOOTIES, 2020, vol.~39, No~3, p.~699-709. ISSN~0253-1933. Available from: https://dx.doi.org/10.20506/rst.39.3.3171.
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