FDA CDRH ODE Off-the-shelf Software Guidance

FDA CDRH Office of Device Evaluation’s “Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices”.This defines submission requirements for information related to use of off-the-shelf software used as part of a medical device. It does not apply directly to production and quality system software.

Pocket booklets of this guidance are available from SoftwareCPR for $3 apiece up to 3 copies and $2 a piece for each copy over 3. Just send email to booklets@softwarecpr.com and include contact information so we can arrange shipment and payment.

SoftwareCPR keywords: OTSS, COTS, Software submissions

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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