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

2023-10-04T04:42:51

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Investigational medical device and methods 6.1 Investigational medical device description ...

2023-07-12T05:11:13

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

2023-07-11T05:59:19

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

2023-07-11T04:39:40

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

2023-07-11T04:32:16

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

2023-06-28T06:47:32

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

2023-06-27T05:32:33

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

2023-06-27T05:14:11

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Introduction The introduction may contain a brief statement placing the clinical investig...

2023-06-02T04:54:41

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