If you answered yes to what was said above, 21 CFR Part 11 applies to you and you must complete and send a no-refusal letter to submit to the FDA. The FDA is subject to strict rules applicable to life sciences companies, especially with respect to electronic registrations and signatures. A key element of compliance with these rules is the submission of a certification letter from 21 CFR, Part 11, better known as a non-contest letter. For those who are unsure what these letters do, how to write one and other details, this guide outlines what you need to know. As part of the compliance process, all life sciences companies must submit a so-called non-contest letter to the FDA. This letter must be stored by the organization or organization that you are not compliant. We have also included the text of the two letter templates below for your comfort: the FDA has provided two standard letters on the official website of the organization`s government. Both contain substitutes in brackets indicating where you need to provide information and what information is needed. The two standard letters of the insemination agreement are available here: www.fda.gov/industry/about-esg/appendix-g-letters-non-repudiation-agreement According to the FDA, all letters of the insemination agreement must be sent to the following address: The following two letters are provided as templates for a letter of no refusal. The bracketed information  is provided by the applicant.
If you fail to submit a non-refusal letter to the FDA, you will be declared non-compliant, even if you have followed all the other steps you request. This could result in the receipt of Form 483 and FDA warning letters. If the situation is not corrected, you may see damage to your organization`s reputation and potentially lost business, as well as other FDA actions. Fortunately, submitting a non-contest letter is simple and takes very little time. [Employee`s name #1]: [Employee`s handwritten signature #1] . Lowell Marshall Electronic Submissions Gateway U.S. Food and Drug Administration 3WFN, Room 7C34 12225 Wilkins Avenue Rockville, MD 20852 . . .
„Previous Appendix,“ „Table of Materials“ „Next Annex.“ Find out what life sciences companies need to know about letters relating to non-recruit agreements, in accordance with Section 11.100 of Title 21 of the Federal Code, which is to certify that [company name], [company address] intends that electronic signatures executed by our employees are the legally binding equivalent of traditional handwritten signatures. A letter of the no-refusal agreement for digital signatures must be sent to the FDA before it registers as a transaction partner for the FDA ESG. The letter must be filed on paper (preferably on the corporate letterhead) and signed with a traditional handwritten signature.