Important Information About Digital/Electronic Signatures

FDA does not require submission of paper copy for electronic submissions submitted using the FDA ESG NextGen. 

FDA forms (e.g, 1571, 356h) and documents require a signature. 

Accepted Signature Methods by FDA are:

• Scanned Signatures: A scanned image of a handwritten signature.
• Digital Signatures: Electronically applied digital signatures.
• Flattened Digital Signatures: A flattened digital signature must include the following: 

  • The printed name of the signer 

  • The date and time when the signature was executed 

  • The reason for the signature 

• eSignatures for ESG NextGen submissions: Drawn eSignatures applied directly within the Unified Submission Portal (USP) by drawing with a mouse, stylus or finger is the only signature method accepted when signing a submission in ESG NextGen USP. 

Please use the Adobe Acrobat Self-Sign plug-in to insert your signature on fillable FDA forms. 

The FDA cannot hold digital signatures to a higher standard than paper signatures. The FDA will not check the signature on an electronic or paper-based submission unless there is a directed inspection involving that submission. Please maintain the security certificates associated with your digital signatures for AS2 and WebTrader submissions in case of a directed inspection. 

The FDA's General Counsel (GC) has said that the FDA must be able to determine the origin of a submission to implement fully electronic submissions. ESG NextGen complies with this through the added security of Multi-Factor Authentication and identity validation, in combination with the electronic signature. 

Please use the 356h fillable PDF forms with your electronic submissions to CDER and CBER via ESG NextGen. 

• If you do not include these forms with your electronic submissions, CBER and CDER will not be able to leverage their automated loading processes, reducing the process to a manual one. This results in a large increase in the time required by the Centers to make submissions available to our review community. 

• 356h and 1571 Form Field Sizes 

  • For documents sent through the ESG for regulatory review, the most important form fields from the FDA's perspective are the application number and the submission type. 

  • The current form fields have the maximum number of characters allowed. If a form field is not large enough, please abbreviate the text in the field. Increasing the size of a form field or otherwise altering a form would require OMB approval. 

  • FDA contractors or administrative reviewers read a submission's cover letter and selected text to determine the nature and content of the submission. FDA-generated data and information is utilized in FDA submission tracking databases. 

Consult with an FDA Center representative to determine which signature method is required for each type of submission. 

Example of a flattened digital signature:

 

Frequently Asked Questions About Digital/Electronic Signatures

Q: A question mark (?) appears if I don't use PDF Self-Sign to create a signature. Will the FDA accept such a submission? 
A: Yes. The FDA will not validate a signature during the submission process unless there is a directed inspection of the submission. 

Q: What if I can't fit my full text into a form field? 
A: The most important form fields are the application number field and the submission type field. If needed, abbreviate the text to fit the field's limitations. 

Q: Because I used a non-public key digital signature, I received an error message during the eCTD validation steps regarding a “secured” PDF file being present within the eCTD. Will by submission still be accepted? 
A: The FDA understands that this can occur and will not reject submissions based on this.