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Guidance forOfftheShelf Software Use in Medical Devices DOCUMENT This guidance document is being distributed for comment purposes only. Office of Device Evaluation Document Issued On: June 4, 1997×Note:

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What is off-form-shelf software use?

Off-the-shelf software refers to software that is ready-made and available for purchase or use without any additional customization. It is designed to meet the common needs of various businesses or individuals and does not require extensive development or coding.

Who is required to file off-form-shelf software use?

There is no specific requirement to file off-the-shelf software use. It is up to the individual or organization to determine if they need to report or document their use of off-the-shelf software for their own internal purposes or compliance with any applicable regulations.

How to fill out off-form-shelf software use?

Filling out off-the-shelf software use typically involves documenting the software being used, its version or edition, the purpose for its use, and any relevant licensing or usage details. This information can be recorded in a spreadsheet, database, or any other preferred format for record-keeping.

What is the purpose of off-form-shelf software use?

The purpose of using off-the-shelf software is to provide a cost-effective and efficient solution for meeting specific business or individual needs. It eliminates the need for extensive in-house development and allows users to leverage the functionalities of pre-built software to streamline their operations or achieve their goals.

What information must be reported on off-form-shelf software use?

The specific information that needs to be reported on off-the-shelf software use may vary depending on individual requirements or regulatory guidelines. However, common details to document include the name of the software, its version, the purpose or function it serves, the date of acquisition, and any relevant licensing or usage terms.

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