How do I submit to FDA?

FDA's preferred method of submission is via the FDA Electronic Submissions Gateway (ESG). For more information, see the Electronic Submissions Gateway web page. For automated processing of your submissions, use the ESG and submit an FDA fillable form with each submission.

Is FDA Form 3514 required?

You do not need to provide an "Indications for Use" page (Form FDA 3881), the "Premarket Review Submission Cover Sheet" (Form FDA 3514), or a "Declaration of Conformity" (if applicable) with your eSTAR since all are built into the eSTAR PDF.

What is a FDA Form 3674?

Form FDA 3674--certifications to accompany drug, biological product, and device applications/submissions: guidance for sponsors, industry, researchers, investigators, and food and drug administration staff. Collection: Health Policy and Services Research.

What is FDA Form 3514?

Form FDA 3514, or the CDRH Premarket Review Submission Cover Sheet, is a voluntary form used to help provide basic administrative info for all types of premarket notification submissions.

Does FDA require expiration dates on medical devices?

The device labeling must include an expiration date based upon an approved shelf life period. The following documents are issued by CDRH and contain guidance on the methods to be used in determining a shelf life for various medical devices.

Get 431 Form 2020-2025

Q: How do I submit to FDA?

FDA&#039;s preferred method of submission is via the FDA Electronic Submissions Gateway (ESG). For more information, see the Electronic Submissions Gateway web page. For automated processing of your submissions, use the ESG and submit an FDA fillable form with each submission.

Q: Is FDA Form 3514 required?

You do not need to provide an &quot;Indications for Use&quot; page (Form FDA 3881), the &quot;Premarket Review Submission Cover Sheet&quot; (Form FDA 3514), or a &quot;Declaration of Conformity&quot; (if applicable) with your eSTAR since all are built into the eSTAR PDF.

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