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Custom Device Exemption Guidance for Industry and Food and Drug Administration Staff Document issued on: September 24, 2014, The draft of this document was issued on January 14, 2014. An agency may

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How to fill out custom device exemption guidance

01

Obtain the custom device exemption guidance document from the relevant regulatory authority.

02

Review the guidance document thoroughly to understand the requirements and instructions for filling out the form.

03

Fill out the form accurately and completely, providing all the necessary information requested.

04

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05

Submit the completed form as per the instructions provided in the guidance document.

Who needs custom device exemption guidance?

01

Manufacturers or importers of custom devices who are seeking an exemption from standard regulatory requirements.

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What is custom device exemption guidance?

Custom device exemption guidance provides information on the process for exempting certain custom devices from premarket notification requirements.

Who is required to file custom device exemption guidance?

Manufacturers of custom devices are required to file custom device exemption guidance.

How to fill out custom device exemption guidance?

Custom device exemption guidance should be filled out accurately and completely according to the instructions provided by the FDA.

What is the purpose of custom device exemption guidance?

The purpose of custom device exemption guidance is to provide manufacturers with a streamlined process for obtaining exemptions for custom devices.

What information must be reported on custom device exemption guidance?

Custom device exemption guidance must include information on the device design, intended use, performance specifications, and justification for exemption.

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