Abstract

GUERRERO, J. C  and  GARCIA, J. H. STUDY OF THE EVALUATION PROCESS OF CLASS II DEVICES IN THE UNITED STATES AND THE RELATION WITH THE ORIGIN AND PREPARATION OF THE MANUFACTURERS. Rev. ing. biomed. [online]. 2015, vol.9, n.18, pp.65-72. ISSN 1909-9762.

The global production of medical devices has increased due to growth in developing countries, hence the evaluation of pre marketing medical devices is needed to provide safety for patients and operators of such technology. In the US evaluation of medical devices is done before marketing depending on the type of device to be introduced. To market Class II devices the developer must present the application 510 (k) by which a study of "approval" of the new device is made to an existing one. However, many producers from different countries take more time to fulfill the requirements of the study indicating that they might not be fully prepared. This article aims to return the number of devices, the duration of study time and device manufacturer's countries applying the study to know the countries that are best prepared in assessing their technology. A database of the FDA was used to establish the countries applying the test 510 (k). A hierarchical classification of countries by discriminating variables as the average length of study and number of studies requested by each country was used. Three groups of countries which are discriminated according to the study duration and the number of devices presented were classified. The first group contains countries that had large amounts of equipment evaluation and had short duration of the study period. Such countries are traditionally recognized as strong producing countries of medical devices. The second group is contrary to the first, countries that submitted few devices and the duration of the study was higher indicating that they are not well prepared for technology assessment. The third group presents variability in the amount of devices presented; however the duration of the study is relatively constant for all countries in this group, which can be classified as developing countries for the production of medical devices. It is necessary to strengthen the production of Class II medical devices in Latin America. The duration of the studies evaluating devices is a great source of information to predict the best prepared countries when assessing their technology manufacturers.

Keywords : Production of medical devices; Technology assessment; Class II devices; 510 test.

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