What does 21 CFR part 16 cover?

21 CFR part 16 is Regulatory Hearing Before the Food and Drug Administration. It runs to 15 sections across 7 subparts and sits in subchapter A of chapter I, General.

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21 CFR Part 16: Regulatory Hearing Before the Food and Drug Administration

Part 16 of title 21 runs to 15 sections across 7 subparts, and sits in subchapter A, General. Every section is reproduced in full and is current to 2026-09-10.

Sections: 15
Subparts: 7
Words of regulation: 3,117
Current to: 2026-09-10

Subpart A: General Provisions

Subpart B: Initiation of Proceedings

Subpart C: Commissioner and Presiding Officer

Subpart D: Procedures for Regulatory Hearing

Subpart E: Administrative Record and Decision

Subpart F: Reconsideration and Stay

16.119 Reconsideration and stay of action1

Subpart G: Judicial Review

16.120 Judicial review1

Read 21 CFR part 16 at the eCFR · All of 21 CFR for food safety

Questions

What does 21 CFR part 16 cover?: 21 CFR part 16 is Regulatory Hearing Before the Food and Drug Administration. It runs to 15 sections across 7 subparts and sits in subchapter A of chapter I, General.

Every section of part 16 is a clause somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.

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Recall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.