FDA Part 11 Redirection and Guidance Notice

FDA issued a formal federal register notice announcing a new draft guidance for Part 11 titled “Part 11, Electronic Records, Electronic Signatures Scope and Application”. This notice also:

  • officially withdraws not only all earlier draft Part 11 guidance documents but it also withdraws the Part Compliance Policy guide
  • formally announces FDA’s intent to reexamine its approach to Part 11, its recognition of serious issues regarding this rule and its impact
  • formally announces FDA’s intent to exercise enforcement discretion with respect to the validation, audit trail, record retention, and record copying requirements of part 11 and to narrow the scope of what qualifies as a regulated electronic record.

These changes can significantly reduce the costs for industry and reduce barriers to further automation.

The full notice is at the link provided and the guidance in a related item on this site (in the news section and in the Part 11 portion of the library.


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