FDA CDRH 510(k) InVivo Detection ofCervicalCancer

“Electro-optical Sensors for the In Vivo Detection of Cervical Cancer and its Precursors:”

This is a submission guidance for an IDE or PMA and it is a draft that was issued for comment of August 25, 1999 and supercedes an earlier 1997 document. This guidance document references the current software submission guidance, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices,” as well as the off-the-shelf software submission guidance and the Draft” General Purpose of Software Validation Guidance” document.

In section 3 on device specifications there is a sub-section on software and this section references the general software submission guidance document and stresses that the information should inculde at a minimum:

-software requirements specifications
-system level test plan with pass/fall criteria and a traceability to requirements
-results of system level testing
-summary of software quality assurance activities
-software hazard analysis

This section also stresses that if the device will use off-the-shelf software including Windows or Digital Processing Software provided by a third party it states five requirements in the submission for each off-the-shelf software component:
1. Title, manufacturer, version number, date
2. Hardware requirements for the OTS software
3. Fucntion of the OTS software
4. Steps taken to validate the intended use of the OTS software
5. Discussion of why use of the OTS software is appropriate

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