How Do Electronic Submissions Relate to 21 CFR Part 11?
FDA’s part 11 regulations (21 cfr part 11), among other things, set forth the criteria under which records submitted to FDA may be submitted in electronic format in place of paper. Section 11.2(b) states that, for records submitted to the Agency, persons may use electronic records in lieu of paper records, in whole or part, provided the requirements of part 11 are met and the documents or parts of documents to be submitted have been identified by the Agency in public docket No. 92S-0251 as being the type of submission the Agency is prepared to accept in electronic format.
