Element card for assessment element A0020 in HTA Core Model Application for Screening Technologies 1.0 application

A. Health Problem and Current Use of the Technology

Regulatory Status

Which market authorization status has the technology in other countries, or international authorities?

Core

Imaging devices may require approval. Substances needed for obtaining images may require additional approval (e.g. radiotracers). In some cases the approval for primary screening is different to that for clinical use (FDA recently licensed tests explicitly for screening), but in most cases approval is obtained for diagnostic use and the test is proposed for screening without any other formal approval.

e.g. CE-Approval, EMEA, national authorities. Manufacturers should be contacted in order to identify which steps have they taken/ are they planning to take concerning market approval

Critical
Complete

Legal Domain

Burls 2000, Busse 2002, Liberati 1997 Imaz-Iglesia 1998, Kristensen 2009