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1Custom Device Exemption2
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8Draft Guidance for Industry and
Food and Drug Administration
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30DRAFT GUIDANCE
This guidance
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What is attachment b cdrh draft?
Attachment B CDRH draft is a form provided by the Center for Devices and Radiological Health (CDRH) for submitting information about medical devices.
Who is required to file attachment b cdrh draft?
Manufacturers or distributors of medical devices are required to file Attachment B CDRH draft.
How to fill out attachment b cdrh draft?
Attachment B CDRH draft can be filled out online through the FDA's registration and listing portal.
What is the purpose of attachment b cdrh draft?
The purpose of Attachment B CDRH draft is to provide important information about medical devices to the FDA for monitoring and regulatory purposes.
What information must be reported on attachment b cdrh draft?
Information such as device classification, manufacturing establishment details, and import/export information must be reported on Attachment B CDRH draft.
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