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Full Description

The Food and Drug Administration (FDA) is issuing regulations that provide criteria for acceptance by FDA, under certain circumstances, of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper. These regulations, which apply to all FDA program areas, are intended to permit the widest possible use of electronic technology, compatible with FDA?s responsibility to promote and protect public health. The use of electronic records as well as their submission to FDA is voluntary. Elsewhere in this issue of the Federal Register, FDA is publishing a document providing information concerning submissions that the agency is prepared to accept electronically.
 

Document History

  1. CFR 21CFR 1-99


    Code of Federal Regulations - Title 21 Part 1 - Part 99 (Food and Drugs)

    • Most Recent
  2. CFR 21CFR 1-99


    Code of Federal Regulations - Title 21 Part 1 - Part 99 (Food and Drugs)

    • Historical Version
  3. CFR 21CFR 1-99


    Code of Federal Regulations - Title 21 Part 1 - Part 99 (Food and Drugs)

    • Historical Version
  4. CFR 21CFR 1-99


    Code of Federal Regulations - Title 21 Part 1 - Part 99 (Food and Drugs)

    • Historical Version
  5. CFR 21CFR 1-99


    Code of Federal Regulations - Title 21 Part 1 - Part 99 (Food and Drugs)

    • Historical Version
  6. CFR 21CFR 1-99


    Code of Federal Regulations - Title 21 Part 1 - Part 99 (Food and Drugs)

    • Historical Version
  7. CFR 21CFR 1-99


    Code of Federal Regulations - Title 21 Part 1 - Part 99 (Food and Drugs)

    • Historical Version
  8. CFR 21CFR 1-99


    Code of Federal Regulations - Title 21 Part 1 - Part 99 (Food and Drugs)

    • Historical Version
  9. CFR 21CFR 1-99


    Code of Federal Regulations - Title 21 Part 1 - Part 99 (Food and Drugs)

    • Historical Version
  10. CFR 21CFR 1-99


    Code of Federal Regulations - Title 21 Part 1 - Part 99 (Food and Drugs)

    • Historical Version
  11. CFR 21CFR Part 11

    👀currently
    viewing


    Code of Federal Regulations - Title 21 Part 11: Electronic Records; Electronic Signatures; Final Rule. Electronic Submissions, Establishment of Public Docket; Notice

    • Historical Version
  12. CFR 21CFR 1-99 2003


    Code of Federal Regulations - Title 21 Part 1 - Part 99 (Food and Drugs)

    • Historical Version