Federal Food, Drug, and Cosmetic Act
This form is printed by the
tracked documents, each as a document defines it. The index’s key is
federal food, drug, and cosmetic act (the definitions derivation’s fold:
case set aside, spaces collapsed; each form is matched exactly as printed).
11 observed texts define it.
Counts below are over each row’s current text, the
81 of 126 current
texts the derivation read; a title is read for every one of the 132 tracked rows.
Defined
1 definition in 1 current text, as the definitions derivation’s rules read them, quoted where the term and its text together sit under the quote cap.
- 21 CFR Part 820 (QMSR)
UStext first observed- no clause given (no numbering read in this text) Federal Food, Drug, and Cosmetic Act: text withheld (over the cap: its term and text are 21 words)
In normative sentences
4 sentences in 2 current texts
printing one of the forms in the heading and one of the sentence derivation’s listed verbs (shall, should, must, is expected, may). A sentence is a row of printed words; nothing here calls it a requirement. A defining occurrence that lies inside such a sentence is counted here and under Defined; only In body leaves out both.
Each sentence is given by the clause the sentence derivation places it under and the verbs it prints, grouped by clause, each clause followed by its count of sentences; its words are not quoted here, and are served by their offsets at /api/v1/modal-sentences.json.
- FDA electronic systems (clinical)
US1 sentence; text first observedno clause anchor before this sentence: 1 sentence (must) - 21 CFR Part 820 (QMSR)
US3 sentences; text first observedno numbering read: 3 sentences (shall, may)
In titles
0 tracked rows whose titles print one of the forms in the heading, read from the title this record holds, by the same exact rule.
No tracked row’s title prints it.
In body
19 occurrences in 9 current texts outside every sentence above and outside the term’s own definitions, each counted under the clause anchor the clause-anchor derivation placed last before it; each clause is followed by its count.
- FDA AI guidance
US1 occurrence; text first observed7: 1 - FDA clinical decision support
US1 occurrence; text first observed1 where no numbering read in this text - FDA device cybersecurity (2026)
US1 occurrence; text first observed6: 1 - FDA electronic systems (clinical)
US1 occurrence; text first observed1 where no heading is read before it - FDA guidance agenda
US5 occurrences; text first observed5 where no numbering read in this text - FDA Part 11 scope
US1 occurrence; text first observed1 where no numbering read in this text - 21 CFR Part 11
US2 occurrences; text first observed2 where no numbering read in this text - 21 CFR Part 211
US1 occurrence; text first observed1 where no numbering read in this text - 21 CFR Part 820 (QMSR)
US6 occurrences; text first observed6 where no numbering read in this text
Co-occurrence
46 other terms of the index share at least one clause of a current text with this one: a clause a definition sits in, the clause of a sentence above, or the clause a body occurrence is counted under. Terms in order of their key; each with the count of clauses shared and the clauses, by row. 22 positions of this term have no placed clause and share none (a defining occurrence inside a sentence above is counted once under each).
- Act 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - Agency 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - allow-list 1 clause:
fda-device-cybersecurity-20266 - Application 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - clinical investigation 1 clause:
fda-ai-guidance7 - Component / component 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - corrective action 1 clause:
fda-device-cybersecurity-20266 - cyber threat 1 clause:
fda-device-cybersecurity-20266 - cybersecurity 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - cybersecurity risk 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - device software function 1 clause:
fda-device-cybersecurity-20266 - end-to-end 1 clause:
fda-device-cybersecurity-20266 - entity 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - hardware 1 clause:
fda-device-cybersecurity-20266 - Harm 1 clause:
fda-device-cybersecurity-20266 - identity management 1 clause:
fda-device-cybersecurity-20266 - incident 1 clause:
fda-device-cybersecurity-20266 - informed consent 1 clause:
fda-device-cybersecurity-20266 - intended use 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - manufacturer 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - medical device 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - operator 1 clause:
fda-device-cybersecurity-20266 - performance 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - Product Lifecycle 1 clause:
fda-ai-guidance7 - provider 1 clause:
fda-device-cybersecurity-20266 - Quality 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - Quality Risk Management 1 clause:
fda-ai-guidance7 - Quality System 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - reasonably foreseeable misuse 1 clause:
fda-device-cybersecurity-20266 - recall 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - representative 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - Requirements 1 clause:
fda-device-cybersecurity-20266 - Risk / risk 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - Risk Assessment 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - Risk Management 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - significant cybersecurity risk 1 clause:
fda-device-cybersecurity-20266 - software 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - source code 1 clause:
fda-device-cybersecurity-20266 - sponsor 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - standard 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - subject 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - System / system 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - training data 1 clause:
fda-ai-guidance7 - UDI 1 clause:
fda-device-cybersecurity-20266 - user 2 clauses:
fda-ai-guidance7;fda-device-cybersecurity-20266 - vulnerability 1 clause:
fda-device-cybersecurity-20266
History
Every text of each row holding the term in any text the store holds under the current version, in the order the texts were first observed. A row’s current text is marked.
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
61d4603ff66e | 0 | 0 | 0 | |
088a7a37c55d | 0 | 0 | 0 | |
630bd27c7b42 | 0 | 0 | 0 | |
5c61f4c6351d (current) | 0 | 0 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
ad537c73610a (current) | 0 | 0 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
b52b706d5cca (current) | 0 | 0 | 0 | |
d34d8c706d88 | 0 | 0 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
b52b706d5cca | 0 | 0 | 0 | |
27c5d1a28e3d unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
d34d8c706d88 (current) | 0 | 0 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
06b24bf9ebcb unmeasured: the retained text opens with a PDF file signature ('%PDF-') | not measured | not measured | not measured | |
74c586849092 (current) | 0 | 1 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
f5e8806992b5 | 0 | 0 | 0 | |
ae6842a2cdd8 (current) | 0 | 0 | 5 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
a5590943862c (current) | 0 | 0 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
f0554d5c3fab | 0 | 0 | 2 | |
6a4d277ca4f8 | 0 | 0 | 2 | |
95bf4a66f2d4 | 0 | 0 | 2 | |
98ed07f87cdd | 0 | 0 | 2 | |
15f94377c4fc | 0 | 0 | 2 | |
9269c75204ff | 0 | 0 | 2 | |
4d93ac00b602 | 0 | 0 | 2 | |
825750c5633d | 0 | 0 | 2 | |
39db0dd17f53 | 0 | 0 | 2 | |
244eba4196bb | 0 | 0 | 2 | |
605180a389c7 | 0 | 0 | 2 | |
ed1c9acbb776 | 0 | 0 | 2 | |
bbbd805d0905 (current) | 0 | 0 | 2 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
393b48f902b8 | 0 | 0 | 1 | |
5997ebbb6661 | 0 | 0 | 1 | |
9d7b6d9aa4e1 | 0 | 0 | 1 | |
18e04a0c925a | 0 | 0 | 1 | |
1e7f13684129 | 0 | 0 | 1 | |
f24b92ecdf42 | 0 | 0 | 1 | |
b670ac9656b7 | 0 | 0 | 1 | |
bc527e48bcd8 | 0 | 0 | 1 | |
4edb9480421c | 0 | 0 | 1 | |
cd3e1c0c936b | 0 | 0 | 1 | |
75605421c92f (current) | 0 | 0 | 1 |
| First observed | Text | Defined | In normative sentences | In body |
|---|---|---|---|---|
8b8ac787c687 | 1 | 3 | 6 | |
fa65ecef3a81 | 1 | 3 | 6 | |
8ee8e1aad0a5 | 1 | 3 | 6 | |
f3605b69e136 | 1 | 3 | 6 | |
baa155d883e3 | 1 | 3 | 6 | |
ac6e97a3c75d | 1 | 3 | 6 | |
bb66b9cbb2c4 | 1 | 3 | 6 | |
0e1bbcb2d14d | 1 | 3 | 6 | |
0eb9eade1868 | 1 | 3 | 6 | |
94a77d5625e8 | 1 | 3 | 6 | |
ca64082d7f23 (current) | 1 | 3 | 6 |
Feed
/atom/term/federal-food-drug-and-cosmetic-act.atom carries one entry for each text of a row whose counts above differ from the row’s previous text, and one for the first text of a row holding the term, dated by the text’s first observation. A new version of the derivation is a change of method and is never an entry.
How this page is derived
From the terms-index derivation’s current version, first derived on
, read from
state/terms-index.jsonl. Threshold: a key enters the index when at least 1 observed text of a tracked row defines it, under the definitions derivation's current version. Its version, its rules and
term set, and the versions of the clause-anchor, definitions and sentence derivations it joins, are on
the derivation methods page, which lists every version of each with
the day it was first derived: a change there is a change of method, never a change in a text.
Not read: a term printed in a form no definition under its key carries: a plural or other ending, another letter case, another spacing or a line break between its words, a hyphenated or abbreviated form, a translation; a term a document defines in a form head 3's rules do not read (its own not_reached names them), which enters no key; an occurrence in a text head 1 refused, which is not read; a title is read for its row and is not dated by a text. A position states where an occurrence lies in a text and nothing about what the text says of the term.
| Entry | text_retained | licence_class | quote_allowed | snapshot_available |
|---|---|---|---|---|
| 21 CFR Part 820 (QMSR) | true | open | true | true |
| 21 CFR Part 11 | true | open | true | true |
| FDA device cybersecurity | true | open | true | true |
| FDA device cybersecurity (2026) | true | open | true | true |
| EU GMP Annex 11 | true | open | true | true |
| EU MDR | true | open | true | true |
| EU Cyber Resilience Act | true | open | true | true |
| EU IVDR | true | open | true | true |
| EU Cybersecurity Act | true | open | true | true |
| EU NIS2 Directive | true | open | true | true |
| ICH Q9(R1) | true | open | true | true |
| EU AI Act | true | open | true | true |
| EU Machinery Regulation | true | open | true | true |
| ICH Q13 | true | open | true | true |
One row for each entry whose own characters this page prints: a text defining a form printed here, or a definition quoted. A row named or linked without its characters printed, or whose title only or sentence clauses only are given, has no row.
Each value is read by the same function the API reads, and each field is defined in the published schema. None of the four is a grant.
Last updated: