Get Sponsor: Subject Device - Accessdata Fda

This guide provides a comprehensive overview of how to effectively fill out the Sponsor: Subject Device - Accessdata FDA form online. It is designed to assist users of all experience levels in navigating the form with clarity and confidence.

Follow the steps to successfully complete your submission.

1. Press the ‘Get Form’ button to access the form and open it in your preferred digital editor.
2. Enter the submitter's information, including the owner's name, establishment registration number, address, and contact details.
3. Fill in the subject device information such as the trade name, common name, classification name, review panel, product code, and regulation class.
4. Provide details for the predicate device information if applicable, including the sponsor name and device specifics.
5. Describe the device by detailing its functions, intended use, and user instructions, including performance summaries relevant to safety standards.
6. Conclude by comparing your device to predicate devices and stating your conclusions about its safety and effectiveness.
7. Review your entries carefully, and once satisfied with the information provided, save your changes, then download, print, or share the completed form as required.

Start filling out your Sponsor: Subject Device - Accessdata FDA form online today!