Result card

  • LEG10: Has the technology marketing authorisation?
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Has the technology marketing authorisation?

Authors: Ingrid Wilbacher

Internal reviewers: Gottfried Endel

Acknowledgments: Hans Seyfried for voluntarily reviewing

A study (one result of the literature research as described in overall method section) was taken for an overview of used fecal occult blood tests as screening tools for CRC in European countries {66}. According to the directive 98/79/EC, Art 2 {93} for in vitro diagnostic medical devices and their accessories each member state has to take all necessary steps to ensure that devices may be placed on the market and/or put into service only if they comply with the requirements laid down in this Directive when duly supplied and properly installed, maintained and used in accordance with their intended purpose. This involves the obligation of Member States to monitor the security and quality of these devices. Due to the fact that EUDAMED {68} is not publically available and does not provide a complete content of registered devices, and that for this paper not every single national registration could be evaluated, the search for market authorization level was done in FDA {67} as a surrogate.

In European countries the following tests were used for CRC screening: Hemoccult, Hemoccult II, RPHA immudia, Alpha Wasserman, Alpha Wasserman Sentinel, FlexSure OBT, and Hema Screen. {Table 2)

The FDA {Food and Drug Administration, U.S.) provides 60 registered fecal occult blood test in a public database (Table 3), by registration number 864655021 and product classification code KHE22. The tests RPHA immudia, Alpha Wasserman, Alpha Wasserman Sentinel, and FlexSure OBT were not found there. Whether and how they are registered in Europe could not be detected by the search as done.

-          There are several fecal occult blood tests registered by the FDA. European registration situation was not found for public access by the search.

-          The tests used for CRC screening in European countries as provided by the study of Benson et al. 2007 [3] were not all found in the FDA registration database.

-          The market authorization has to be checked for the tests RPHA immudia, Alpha Wasserman, Alpha Wasserman Sentinel, and FlexSure OBT.

Wilbacher I Result Card LEG10 In: Wilbacher I Legal aspects In: Jefferson T, Cerbo M, Vicari N [eds.]. Fecal Immunochemical Test (FIT ) versus guaiac-based fecal occult blood test (FOBT) for colorectal cancer screening [Core HTA], Agenas - Agenzia nazionale per i servizi sanitari regionali; 2014. [cited 7 February 2023]. Available from: