FDA CDRH 510(k) Bone Growth Stimulator Device

“Guidance Document for Industry and CDRH Staff for the Preparation of Investigational Device Exemptions and Premarket Approval Applications for Bone Growth Stimulator Devices”

This is a draft guidance that was relesed for comment on March 18, 1998. Sub section F under the Device Description section is on software and firmware. It states that adequate detail should be provided in the submission to allow review of the degree to which the software meets the funcitonal requirements, the validation and verification performed, the hazard analysis, and the testing perfomed. It references the obsolete reviewer guidance for computer controlled medical devices, “Reviewer Guidance for Computer Controlled Medical Devices Udergoing 510(k) Review,” and the draft of the new software submission guidance, “Guidance for the Content of Premarket Submisssions for Software Contained in Medical Devices,” at this point the current final software submission guidance is the correct reference.

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