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, and also to satisfy the requirements of 21 CFR 11.100(c) . The letter must be submitted (preferably on company letterhead) and signed with a traditional handwritten signature. Users requesting a new ESG account must send an electronic copy of their Letter of Non Repudiation to ESGHelpDesk@fda.hhs.gov.
The following letter is provided as a sample of a letter of Non-Repudiation Agreement. The information in square brackets [ ] will be provided by the submitter.
La Misha Fields
Electronic Submissions Gateway
U.S Food and Drug Administration
3WFN, Room 1234
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.
[Name of Company Representative]
[Company Representative Title]