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DRAFT 922016 Guidance for Abbreviated IDE Requirements The Principal Investigator of a study that is requesting an abbreviated IDE for use of a nonsignificant risk device must attest to the following: 1.

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What is guidance for abbreviated IDE?

Guidance for abbreviated IDE is a document that provides instructions and assistance on how to complete and submit an Abbreviated Investigational Device Exemption (IDE) application.

Who is required to file guidance for abbreviated IDE?

Any organization or individual planning to submit an Abbreviated IDE application is required to file guidance for abbreviated IDE.

How to fill out guidance for abbreviated IDE?

Guidance for abbreviated IDE can be filled out by following the specific instructions provided in the document and providing accurate information about the proposed medical device.

What is the purpose of guidance for abbreviated IDE?

The purpose of guidance for abbreviated IDE is to ensure that the Abbreviated IDE application is completed correctly and contains all necessary information for the FDA to review the proposed medical device.

What information must be reported on guidance for abbreviated IDE?

Information such as device description, clinical testing plans, risk analysis, and labeling must be reported on guidance for abbreviated IDE.

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