eCFR Analyzer

Food and Drug Administration (FDA)

2,768,897Words in 250 parts
9.8Restriction density (per 1,000 words)
16.7Reading grade
72.4%Unchanged since 2017
30Flagged parts
2026-10-30Last change

Section changes per year

From the eCFR versioner, for the parts that the agency owns now. Before 2017 is the baseline load.

Text and size

Sentences
27.4 words on average; 21.2% over 40 words; 29.2% passive; 15.1 cross-references per 1,000 words
Sentence types
definition 2.8% · prohibition 1.7% · paperwork 4.9% · obligation 15.8% · permission 8.4% · other 66.4%
Checksum
870aefb8f060775365711c18ca066f25d4cfbf960fc319157d6f80f93bdbf0a0

Review candidates in this agency

RankPartWordsScore
23 21 CFR 111 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS
High signals: Directive share +2.4 SD · Paperwork share +2.2 SD · Restriction density +1.6 SD · Reading grade +1.5 SD
15,693 1.59
30 21 CFR 1003 NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY
High signals: Paperwork share +3.4 SD · Directive share +2.5 SD · Restriction density +1.7 SD · Reading grade +1.5 SD
2,076 1.52
31 21 CFR 106 INFANT FORMULA REQUIREMENTS PERTAINING TO CURRENT GOOD MANUFACTURING PRACTICE, QUALITY CONTROL PROCEDURES, QUALITY FACTORS, RECORDS AND REPORTS, AND NOTIFICATIONS
High signals: Directive share +2.5 SD · Paperwork share +1.9 SD · Reading grade +1.6 SD · Restriction density +1.4 SD
17,241 1.51
56 21 CFR 211 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
High signals: Directive share +2.8 SD · Restriction density +2.8 SD
12,013 1.31
64 21 CFR 99 DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES
High signals: Paperwork share +3.0 SD · Reading grade +2.4 SD · Directive share +1.2 SD
7,256 1.28
113 21 CFR 21 PROTECTION OF PRIVACY
High signals: Paperwork share +3.1 SD
10,681 1.11
115 21 CFR 507 CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR FOOD FOR ANIMALS
High signals: Reading grade +2.5 SD · Directive share +1.3 SD · Size +1.1 SD
20,674 1.11
145 21 CFR 225 CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS
High signals: Restriction density +2.7 SD · Directive share +1.8 SD · Paperwork share +1.6 SD
4,046 1.06
159 21 CFR 803 MEDICAL DEVICE REPORTING
High signals: Paperwork share +3.7 SD
10,544 1.05
214 21 CFR 610 GENERAL BIOLOGICAL PRODUCTS STANDARDS
High signals: Directive share +1.9 SD · Restriction density +1.1 SD
10,665 0.97
257 21 CFR 108 EMERGENCY PERMIT CONTROL
High signals: Paperwork share +1.4 SD · Directive share +1.4 SD
6,299 0.92
317 21 CFR 900 MAMMOGRAPHY
High signals: Restriction density +1.6 SD · Directive share +1.4 SD · Size +1.2 SD
23,624 0.87
321 21 CFR 640 ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
High signals: Restriction density +2.5 SD · Directive share +2.1 SD
14,281 0.87
352 21 CFR 502 COMMON OR USUAL NAMES FOR NONSTANDARDIZED ANIMAL FOODS
High signals: Directive share +2.5 SD · Restriction density +1.7 SD
1,006 0.84
407 21 CFR 113 THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS
High signals: Restriction density +2.6 SD · Directive share +1.2 SD
18,371 0.81
448 21 CFR 213 CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES
High signals: Restriction density +2.8 SD · Directive share +2.2 SD · Paperwork share +1.2 SD
6,989 0.79
454 21 CFR 1002 RECORDS AND REPORTS
High signals: Paperwork share +2.6 SD
4,328 0.79
457 21 CFR 226 CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES
High signals: Restriction density +1.5 SD · Directive share +1.3 SD · Paperwork share +1.3 SD
2,648 0.78
486 21 CFR 515 MEDICATED FEED MILL LICENSE
High signals: Paperwork share +2.2 SD · Reading grade +1.4 SD
2,618 0.77
500 21 CFR 821 MEDICAL DEVICE TRACKING REQUIREMENTS
High signals: Reading grade +2.1 SD · Paperwork share +1.2 SD
3,820 0.76
506 21 CFR 205 GUIDELINES FOR STATE LICENSING OF WHOLESALE PRESCRIPTION DRUG DISTRIBUTORS
High signals: Directive share +1.6 SD · Restriction density +1.3 SD
2,828 0.76
521 21 CFR 101 FOOD LABELING
High signals: Size +2.6 SD · Reading grade +1.1 SD
116,658 0.75
542 21 CFR 501 ANIMAL FOOD LABELING
High signals: Directive share +1.4 SD
11,855 0.75
563 21 CFR 1 GENERAL ENFORCEMENT REGULATIONS
High signals: Size +2.4 SD · Paperwork share +1.1 SD
102,393 0.74
598 21 CFR 807 ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES
High signals: Reading grade +1.8 SD · Paperwork share +1.1 SD
11,144 0.72

Score: the mean of six signals, in standard deviations (SD). Across the CFR, the top 641 of 6,402 ranked parts (10%) get a flag for review; this list shows 25. A flag is not a finding.

Statutes behind the most text

  • 21 U.S.C. 321: 1,639,208 words in 145 parts (59.2% of this agency's text)
  • 21 U.S.C. 351: 523,210 words in 30 parts (18.9% of this agency's text)
  • 42 U.S.C. 216: 361,918 words in 25 parts (13.1% of this agency's text)
  • 42 U.S.C. 243: 194,288 words in 6 parts (7.0% of this agency's text)
  • 21 U.S.C. 360b: 155,221 words in 7 parts (5.6% of this agency's text)
  • 15 U.S.C. 1453: 132,144 words in 3 parts (4.8% of this agency's text)
  • 15 U.S.C. 1333: 104,584 words in 2 parts (3.8% of this agency's text)
  • 19 U.S.C. 1490: 102,393 words in 1 parts (3.7% of this agency's text)
  • 15 U.S.C. 1451: 83,833 words in 9 parts (3.0% of this agency's text)
  • 21 U.S.C. 331: 81,241 words in 9 parts (2.9% of this agency's text)

From the authority notes. A citation is not proof that the statute requires the rule.

Largest parts

  • 21 CFR 101: FOOD LABELING (116,658 words)
  • 21 CFR 866: IMMUNOLOGY AND MICROBIOLOGY DEVICES (103,134 words)
  • 21 CFR 1: GENERAL ENFORCEMENT REGULATIONS (102,393 words)
  • 21 CFR 177: INDIRECT FOOD ADDITIVES: POLYMERS (74,752 words)
  • 21 CFR 558: NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS (74,395 words)
  • 21 CFR 520: ORAL DOSAGE FORM NEW ANIMAL DRUGS (70,841 words)
  • 21 CFR 184: DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE (69,642 words)
  • 21 CFR 314: APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG (68,078 words)
  • 21 CFR 178: INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS (67,579 words)
  • 21 CFR 201: LABELING (64,094 words)

Reading grade and sentence types are approximate. Simple rules label each sentence; the first match wins.