FDA DSMA Software Display/Labeling

The FDA CDRH Division of Small Manufacturer’s Assistance provides a variety of advice to companies to assist them in complying with FDA regulations. DSMA primary mission is education. A common question when dealing with computer user interfaces is whether or not the displayed information is considered to be “labeling” which has a specific regulatory connotation. DSMA makes the following statement in their device advice on labeling:

“Whether a firm considers a software driven display to be labeling or data makes little difference under the Quality System regulation, because either way, the finished device labeling or data must meet the device master record specifications. When firms develop and validate software, they should also review these electronic displays to see that the “labeling” meets all applicable requirements, such as adherence to specifications in the device master record, correct parameter identification, agreement with the instruction manual, and of course, correct display of performance data.”

The main link to DSMA’s device advice is provided. It provides a free source of useful information directly from FDA. It should be noted, however, that DSMA educational documents do not carry the force of law nor are they “official” FDA guidance documents.

SoftwareCPR Keywords: User Interface

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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