Overall synopsis of the clinical investigation A summary or overview of the clinical ...

Types of Case Report Forms The following is a suggested list of CRFs that may be deve ...

For a new in vitro diagnostic medical device: Where relevant to demonstrating conform ...

For a new in vitro diagnostic medical device: Where relevant to demonstrating conform ...

Investigational medical device and methods 6.1 Investigational medical device descrip ...

Definition of Assay Cut-off: This section should provide a summary of analytical data ...

Subjects (a) Inclusion criteria for subject selection. (b) Exclusion criteria for sub ...

14.0 Definition of Assay Cut-off: This section should provide a summary of analytical ...