FDA CDRH’s Office of Device Evaluation “Non-invasive Blood Pressure (NIBP) Monitor Guidance” issued March 10, 1997 as a medical device specific 510(k) Submission guidance. There is a software section in this document that describes the software documentation expected as part of the a 510(k) submission for a non-invasive blood pressure monitors. Note that this 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.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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