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Biotech / Medical : Guided Therapeutics - GTHP
GTHP 0.2700.0%Oct 31 9:30 AM EDT
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To: caly who wrote (63)5/5/2010 9:56:07 AM
From: caly  Read Replies (1) of 118
 
fda.gov

Table of Contents for Module 1
Executive Summary*
Device Description and Principles of Operation
Declaration of Conformance to Standards for Module 1
Bibliography/References for Module 1
Non-clinical Laboratory Studies, for example:
Physico-Chemical Testing
Biocompatability/Toxicity Testing
Animal/Biological Testing

Table of Contents for Module 2
Executive Summary*
Device Description and Principles of Operation
Declaration of Conformance to Standards for Module 2
Bibliography/References for Module 2
Non-clinical Laboratory Studies, for example:
Engineering/Bench Testing
Sterilization, Shelf Life & Packaging Information (Pertinent information should also be provided in the manufacturing section)
Software Validation and Verification Information

Table of Contents for Module 3
Executive Summary*
Device Description and Principles of Operation
Manufacturing Information
Refer to "Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff" (February 2, 2003)
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