Get Pre-submission Process

Navigating the Pre-Submission Process can be essential for obtaining feedback on medical device submissions from the Food and Drug Administration (FDA). This guide offers a clear, step-by-step method for effectively completing the necessary form online, ensuring users receive the information they need to guide product development.

Follow the steps to accurately complete the Pre-Submission Process form.

1. Press the ‘Get Form’ button to access the Pre-Submission Process form and open it in your editing interface.
2. Provide a cover letter that includes your contact information and the name of the subject device. This is essential for ensuring that the FDA can easily get in touch with you.
3. Create a table of contents at the beginning of your form to aid in navigation.
4. Include a detailed device description that encompasses pictures, diagrams, and key characteristics, explaining how the device operates.
5. Articulate the proposed intended use or indications for use of the device, detailing the target condition and the population it aims to serve.
6. Summarize any prior discussions or submissions related to this device, referencing submission numbers where applicable.
7. Outline your product development plan, including details about both nonclinical and clinical testing.
8. List specific questions for feedback that you wish to ask the FDA regarding your planned IDE, IND, or marketing application.
9. Define your desired method for receiving feedback, and include three proposed dates and times for a potential meeting.
10. Review your form for completeness and accuracy before submitting it to ensure all necessary sections are filled out.

Complete the Pre-Submission Process form online to receive valuable feedback from the FDA.