(a) For records that are required to be maintained but not submitted to FDA, a person may use all or part of an electronic record in place of a paper record or use an electronic signature in place of a traditional signature if the requirements of this section are met. (b) For electronic records submitted to FDA, one may use all or part of an electronic record in place of a paper record or an electronic signature in place of a traditional signature (hand signature) if:

(1) The requirements of this clause are met

(2) The submitted document, or portion thereof, has been identified as a type of submission received electronically by FDA in Public Abstract No. 92S-0251. This summary will clearly identify what types of documents or portions of documents are acceptable for electronic submission when there is no paper record and the FDA receiving unit (e.g., a specific center, office, department, branch) . Documents they submit electronically to FDA receiving entities will not be considered official if this is not made clear on the public docket; the written form of such documents will be considered official but must be accompanied by an electronic record. It is expected that details (e.g., delivery methods, media, file formats, and technical protocols) will be negotiated with future FDA receiving entities on how and whether to conduct electronic submissions.