Letters of Non-Repudiation Agreement

A Letter of Non-Repudiation Agreement for digital signatures must be submitted to the FDA prior to registering as a transaction partner for the FDA ESG NextGen. The letter must be submitted (preferably on company letterhead) and signed with a traditional handwritten signature. Users requesting a new ESG NextGen user account must generate or upload an electronic version of their Letter of Non-Repudiation Agreement during account registration in the Unified Submission Portal (USP). AS2 (Gateway-to-Gateway) users may also generate or upload an electronic version of their Letter of Non-Repudiation Agreement in the USP. Users are no longer required to submit a physical copy to the FDA. Submitting a physical copy is now optional. Users who would like to continue to send a physical copy to the FDA can do so by sending the letter to:

Jessica Bernhardt
Electronic Submissions Gateway
U.S. Food and Drug Administration
3WFN, Room 7C34
12225 Wilkins Avenue
Rockville, MD 20852

Samples: Letter of Non-Repudiation Agreement

The following two letters are provided as samples for a Letter of Non-Repudiation Agreement. The information in square brackets [ ] will be provided by the submitter.

In both letter examples, the company information must be provided within the body of the letter. For the Individual Non-Repudiation Letter, the signature of the person(s) referenced in the body of the letter must be included. 

INDIVIDUAL NON-REPUDIATION LETTER EXAMPLE 

[Company Letterhead]

[Today's Date]

Jessica Bernhardt
Electronic Submissions Gateway
U.S. Food and Drug Administration
3WFN, Room 7C34
12225 Wilkins Avenue
Rockville, MD 20852

Re: Electronic Signatures

Dear Sir or Madam:

Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that [Company Name], [Company Address], intends that electronic signatures executed by our employees, [List of employee names] are the legally binding equivalent of traditional hand-written signatures.

Sincerely yours,

[Hand-written signature]
[Company Representative Title]

[Employee Name #1]: _________ [Hand-written signature of employee #1]

[Employee Name #2]: _________ [Hand-written signature of employee #2]

[Employee Name #3]: _________ [Hand-written signature of employee #3]

[etc]

 

COMPANY-WIDE NON-REPUDIATION LETTER EXAMPLE

[Company Letterhead]

[Today's Date]

Jessica Bernhardt
Electronic Submissions Gateway
U.S. Food and Drug Administration
3WFN, Room 7C34
12225 Wilkins Avenue
Rockville, MD 20852

Re: Electronic Signature Certificate Statement

To Whom It May Concern:

Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that [Company Name], intends that all electronic signatures executed by our employees, agents, or representatives, located anywhere in the world, are the legally binding equivalent of traditional hand-written signatures.

Sincerely yours,

[Hand-written signature]

[Name of Company Representative]
[Company Representative Title]

 

*If using USPS, do NOT use Priority Mail Express.