To those that are familiar with IVD and CDx regulations in Brazil, is there a regulatory requirement similar to a US IDE in Brazil for using an investigational CDx to identify subjects eligible for treatment in a pivotal drug trial? Is there an application specific for the IVD or is use of the investigational IVD requested in the pre-trial drug application.
Thanks in advance for any insight.
Deb
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Deborah Morris
Sr. Director, Clinical
Myraqa, Inc.
Redondo Beach CA
United States
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