FDA CDRH 510(k) Vitreous Aspiration

“Third Party Review Guidance ForVitreous Aspiration & Cutting Device Premaket Notification (510(k))”

This document was issued on January 31, 1997 for use in the third party review program.

It mentions software in several places including requiring a desctiption for software components that are part of the device, and providing software test information as part of the performace data, and in the section on summary of equivalence it mentions that the device comparison should include information about the software in terms of its similarity in the proposed and predicate devices.

This document also references an obsolete software submission guidance, “Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review,” and at this point in time the new software submission guidance entitled, “Guidance for the Content of Premarket Submission for Software Contained in Medical Devices,” should be used in preparation of the submission instead.

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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