other · Food and Drug Administration · Rule · Published 2023-03-02 · Effective 2023-03-02 · 88 FR 13018
Document
Document number
2023-04010
Federal Register citation
88 FR 13018
CFR reference
21 CFR 11
Type
Rule
Action
Final rule; technical amendment.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2023-03-02
Effective date
2023-03-02
HHS docket
Docket No. FDA-2019-N-0646
Abstract
Before using an electronic signature in an electronic record required by the Food and Drug Administration (FDA or Agency), a person must submit a letter of non-repudiation to FDA. Letters of non- repudiation are required to certify that a person's electronic signatures are intended to be the legally binding equivalent of traditional handwritten signatures. FDA is amending its regulations to update the address for submission of a certification in paper form and to provide an option for electronic submission. This amendment is to ensure accuracy and clarity in the Agency's regulations. This technical amendment is nonsubstantive.