Compare FDA AI guidance (drugs) and 21 CFR Part 211
How to read this page
- How they are linked says why these two documents are connected. Links explained
- Side by side places facts from each record together, so you can see status, weight and dates at a glance.
- It does not compare content. It does not say which is stricter. Read the official texts for that.
How they are linked
- FDA AI guidance (drugs) is related to 21 CFR Part 211 · Source Unverified link
Side by side
| FDA AI guidance (drugs) | 21 CFR Part 211 | |
|---|---|---|
| Authority | FDA | FDA |
| Legal weight | Guidance & Q&A | Law & regulation |
| Status | Draft | In force |
| Last verified | Not yet | Not yet |
| Summary | FDA draft guidance proposing a risk-based credibility framework for AI models whose output supports regulatory decisions about drugs and biologics. Still a draft (docket FDA-2024-D-4689). | US CGMP rules for finished pharmaceuticals. Section 211.68 allows computers and automated equipment in manufacture if they are routinely checked under a written program. It requires controls so only authorised people change master records, checks on input and output, and a backup of data. |
| Lifecycle |
|
|
| Source | Official text Source: FDA. Public domain. | Official text Source: FDA. Public domain. |
These facts are placed side by side from each record. This page does not say which is stricter or whether requirements differ. Read the official texts.