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Reprinted from FDA's website by EAS Consulting Group, LLC Custom Device Exemption Guidance for Industry and Food and Drug Administration Staff Document issued on: September 24, 2014, The draft of

How to fill out custom device exemption guidance

How to fill out custom device exemption guidance?

1. Start by reviewing the purpose of the custom device exemption guidance. Understand that this guidance is intended for manufacturers who seek an exemption from certain requirements for their custom devices.
2. Familiarize yourself with the relevant regulations and guidelines, such as the requirements set forth by the regulatory authority responsible for medical devices in your region. This will help ensure that you are following the correct procedures and submitting the necessary information.
3. Gather all the necessary information and documentation for your custom device exemption application. This may include detailed descriptions of the device, its intended use, design specifications, manufacturing process, and any scientific or clinical data supporting its safety and effectiveness.
4. Carefully complete all the sections of the custom device exemption guidance form. Provide accurate and detailed information, ensuring that you address each question or requirement thoroughly.
5. If any sections or questions are not applicable to your specific device or situation, clearly state the reasons why in the appropriate fields. It is important to provide clear and concise explanations for any deviations or exemptions requested.
6. Double-check all the information provided in your application form for accuracy and completeness. Ensure that all required supporting documentation is included and properly referenced within the form.
7. Submit your filled-out custom device exemption guidance form and supporting documents to the regulatory authority according to their specified submission process. Be aware of any deadlines or additional requirements for submission.
8. Keep a copy of your submission for your records and make note of any reference or tracking numbers provided by the regulatory authority. This will help you track the progress of your application and facilitate any future communications with the authority regarding your custom device exemption.
9. Be prepared to engage in a dialogue with the regulatory authority if they have any questions or require further information. Cooperate promptly and provide any requested additional documentation or clarifications to support your custom device exemption application.
10. Finally, monitor the progress of your custom device exemption application and adhere to any instructions or requirements provided by the regulatory authority until a decision is reached.

Who needs custom device exemption guidance?

1. Custom device exemption guidance is typically needed by medical device manufacturers who intend to seek an exemption from certain regulatory requirements for their custom devices.
2. Manufacturers who develop and produce medical devices that are not commercially distributed and are specifically tailored to meet the needs of individual patients or healthcare professionals may seek a custom device exemption.
3. Custom device exemption guidance is also relevant for manufacturers who wish to provide additional modifications or alterations to existing commercially distributed devices on a case-by-case basis, which may deviate from standard regulatory requirements.

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What is custom device exemption guidance?

Custom device exemption guidance is a document that outlines specific requirements and procedures for manufacturers seeking an exemption for custom devices from certain regulatory 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 according to the instructions provided by the regulatory authority and must include all required information.

What is the purpose of custom device exemption guidance?

The purpose of custom device exemption guidance is to ensure that manufacturers of custom devices comply with regulatory requirements while allowing for exemptions in certain cases.

What information must be reported on custom device exemption guidance?

Custom device exemption guidance must include information about the manufacturer, the custom device in question, the reason for seeking an exemption, and any supporting documentation.

How can I get custom device exemption guidance?

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