FDA Seeks Comments on Digital Records Paperwork—Thrills Not Included
Published Date: 10/28/2026
Notice
Summary
The FDA wants your thoughts on how they collect info about electronic records and signatures. This affects anyone who deals with FDA rules on digital paperwork. You’ve got until December 28, 2026, to share your comments—no cost to join, just your voice!
Analyzed Economic Effects
6 provisions identified: 1 benefits, 5 costs, 0 mixed.
Recordkeeping for closed systems: 20 hours each
If you use a closed electronic system to create, modify, maintain, archive, retrieve, or transmit records under FDA rules (Sec. 11.10), FDA estimates 2,500 recordkeepers will each spend 20 hours per year establishing required controls, totaling 50,000 hours annually.
Recordkeeping for open systems: 20 hours each
If you use an open electronic system to handle FDA-regulated records (Sec. 11.30), FDA estimates 2,500 recordkeepers will each spend 20 hours per year establishing required controls, totaling 50,000 hours annually.
Electronic signature recordkeeping: 20 hours each
For signature-related requirements (Sec. 11.50), FDA estimates 5,000 recordkeepers will each spend 20 hours per year on signature manifestation recordkeeping, totaling 100,000 hours annually.
ID and password controls: 20 hours per recordkeeper
To meet Sec. 11.300 controls for identifications and passwords, FDA estimates 5,000 recordkeepers will each spend 20 hours per year establishing and maintaining those controls, totaling 100,000 hours annually.
You must submit a nonrepudiation letter
If you plan to use an electronic signature in an FDA-required electronic record, you must submit a letter of nonrepudiation under Sec. 11.100(c) certifying the signature is intended to be legally equivalent to a handwritten signature. FDA estimates 5,000 such letters are submitted each year and counts 1 hour per submission (5,000 total hours annually).
No capital or O&M costs claimed
FDA states there are no capital costs or operating and maintenance (O&M) costs associated with this information collection for electronic records and signatures.
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