Predicate Rules

Predicate Rules are the FDA’s actual requirements, such as 21 CFR 211 for pharmaceuticals or Part 820 (the QMSR since 2026) for medical devices. They determine which records must be kept and which signatures must be applied. 21 CFR Part 11 itself does not require any record or signature; it only governs the requirements for their electronic form. The term does not come from Part 11 but from the FDA guidances on it. The Scope and Application guidance of 2003 coined it and deliberately construed the scope narrowly: what no predicate rule requires does not become a Part 11 record. Anyone looking to justify record-keeping or signature obligations therefore looks to the requirements, not to Part 11.