FDA CDRH Hemodialysis Delivery 510(k) Guidance

FDA CDRH Office of Device Evaluation’s “Guidance for the Content of Premarket Notifications for Hemodialysis Delivery Systems” issued August 7, 1998.. Section VII D addresses software by referencing the general software and Off-the-shelf software Submission guidances and providing some information on how the software documentation should be organized in the Submission. In the labeling section it indicates that the model number and software version number for the medical device should be indicated in the Device Labeling.

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