Regulation of veterinary point-of-care testing in the European Union, the United States of America and Japan

Abstract

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. KeywordsEuropean Union -Japan -Point-of-care testing -Regulation -United States of America -Veterinary diagnostics.

Point-of-Care Diagnostics for Farm Animal Diseases: From Biosensors to Integrated Lab-on-Chip Devices

“…An excellent work reviewing the current regulation was published on the OIE webpage by Potockova, Dohnal, and Thome-Kromer (2021). The level of regulatory monitoring differs across the globe, ranging from no regulation in the EU market to strict regulation, similar to that of human in vitro diagnostics, in Japan [ 185 ].…”

“…In the EU region, POC veterinary tests are only required to comply with general directives regarding products marketed within the union. More specifically, POC veterinary tests must comply with Directive 85/374/EEC, on product liability, and Directive 2001/95/EC, on product safety, whereas devices that use electricity (e.g., benchtop analyzers) must comply with Directives 2014/30/EU and 2014/35/EU on electromagnetic compatibility and low-voltage instruments, respectively [ 185 ]. Currently, there is no available legislation regarding the safety, quality, and performance of veterinary POC diagnostics.…”

“…Moreover, end users are encouraged to report adverse events related to the use of the tests. The jurisdiction over POC devices and tests for animal diseases is held by the Center of Veterinary Biologicals of the United States Department of Agriculture, according to the Virus-Serum-Toxin Act, Title 9, Code of Federal Regulation, Parts 101–104 [ 185 , 186 ]. The sensitivity, specificity, and reproducibility of POC tests must be validated across multiple laboratories to acquire licenses and reach the US market.…”

“…The marketing of POC products requires the registration of the manufacturing plant to the local prefecture or the ministry for foreign manufacturers, the appointment of a marketing authorization holder, and approval for each marketed device. Compliance with the regulations is verified every 5 years by on-site visits from the competent authority’s delegates [ 185 ].…”