FDA CDRH 510(k) Thermal Endometrial Ablation

“Thermal Endometrial Ablation Devices” Submission guidance for an IDE

This document was issued on March 14, 1996. Section 2.D is on software. It requests documentation describing the software developmet life cycle and risk management activities including:
1. A description of the software development and QA activities over the life cycle
2. System and software requirements and design inculding hardware requirements, programming language and program size, software functional requirements, traceablity between safety requirements and hazards should be clearly indicated states
3. A software chart depicting the partition of the system into functional units
4. A description of the V&B activities at unit integration and system level, including pass/fail criteria, and the system level functional test plan. Traceability between hazards, safety functions, and testing should be demonstrated
5. A summary of the verification and validation test results
6. Current software version number and date, as well as a list of any remaining bugs or errors

It then references the now obsolete 1991 software submission guidance, “Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review,” and at this point the current software submission guidance, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices,” should be used.

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