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OTS Software Guidance Update Underscores Industry Advancements

 
• By Hannah Daniel

The Off-the-Shelf Software Guidance updates highlight industry advancements.

lines of code on a computer screen
• Source: Shutterstock

The updated final Off-the-Shelf Software Use in Medical Devices guidance document from the US Food and Drug Administration reflects the advancement of software in the industry.

Off-the-shelf software is defined by the FDA as general-purpose software not specific to medical devices.

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