FDA CDRH 510(k) 1-Consolidated Annual Report

“1-Consolidated Annual Report for a Device product line (1-CARD)”

This document was issued on July 6, 2000. Subtitled “Pilot for preparation of annual reports for pacemaker premarket approval applications”

Software is mentioned in several places in section 5 of this guidance document. Where referenced the guidance states that ” If a failed software module is contained in other platforms, device families or models, these other models should be identified along with an analysis as to whether or not the other models are affected by the failure mode.” It goes on to state that “Failures found in a component or software module that affect more than one platform, family, or model need only be reported one time, as long as each affected model of family of devices is listed.”

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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