SMB Validation

Do you have a format or example for the certification for e-signatures that a company can send to the FDA?

For the exact wording for the e-sig certification, please consult the FDA website at One can also find wording for the certification in the preamble of the final Rule. The response to comment #120 is "…The final rule instructs persons to send certifications to FDA's Office of Regional Operations (HFC-100), 5600 Fishers Lane, Rockville, MD 20857. Persons outside the United States may send their certifications to the same office. The agency offers, as guidance, an example of an acceptable Sec. 11.100(c) certification: Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that [name of organization] intends that all electronic signatures executed by our employees, agents, or representatives, located anywhere in the world, are the legally binding equivalent of traditional handwritten signatures."