FDA CDRH 510(k) Communication/Control Systems

“Guidance Document For the Preparation of Premarket Notification [510(K)] Applications For Communications Systems (Powered and Non-Powered) and Powered Environmental Control Systems”

This guidance relates to restortive devices. It references the obsolete 1991 FDA software guidance, “Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review,” but at this time one should refer to the current software submission guidance, “Guidance for the Content of Premarket Submission for Software Contained in Medical Devices.” It also emphasizes and includes the paragraphs listed below relevant to software information to be provided in the submission:

“If your device uses controlling software, you should refer to the FDA document entitled “Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review”, dated August 29, 1991. As described in this document, you should determine and justify the level of concern you believe to be associated with your device’s software. Further, in accordance with this guidance, provide documentation, commensurate with the level of concern, including: 1) System and Software Requirements & Design, 2) Software Development, 3) Verification & Validation (V&V), 4) Test Results and Analysis, and 5) Certification. You must also provide a hazards analysis for the software, identifying safety requirements for the software and system.”

“Please be advised that if you provide only the minimum information highlighted in the “510(k) Review Software Documentation Matrix”, this may not assure adequate information to make a determination about the software. In documenting V&V procedures (all levels of concern), you should provide pass/fail and test completion criteria, and a system level functional test plan. You should refer to the sample questions provided in this guidance and to other sources, as necessary. You are encouraged to submit a summary of the development life cycle in terms of how it assures traceability of the safety concerns throughout development, and how the testing and analyses adequately demonstrate that the software meets its functional and safety requirements. Overall, the software documentation provided should allow for an adequate assessment of the quality of the software design and development, and of the level of software quality control.”

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