FDA CDRH ODE Portable Glucose Monitor Guidance

FDA CDRH’s Office of Device Evaluation “Review Criteria Assessment of Portable Blood Glucose Monitoring In Vitro Diagnostic Devices Using Glucose Oxidase, Dehydrogenase or Hexokinase Methodology” the draft issued February 28, 1997 as a medical device specific 510(k) Submission guidance. There is av software verification and validation section in this document that describes the software documentation expected as part of the a 510(k) submission. . Note that this is a draft document was issued prior to the most recent general software submission guidances including the Off-the-shelf software submission guidance so the requirements of these general guidances should also be considered.