| Health and Human Services Department |
87 FR 50698 |
21 CFR 808 |
ANSI/ASA S3.22-2014 (R2020) |
2014 |
Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids
|
Acoustical Society of America |
| Health and Human Services Department |
87 FR 50698 |
21 CFR 808 |
ANSI/CTA-2051 |
2017 |
Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids
|
Consumer Technology Association |
| Food and Drug Administration |
|
21 CFR 801.430(f)(2) |
ASTM D3492 |
1997 |
Standard Specification for Rubber Contraceptives (Male Condoms)
|
ASTM International |
| Food and Drug Administration |
|
21 CFR 801.420(c)(4) |
ANSI S3.22 |
2003 |
Specification for Hearing Aid Characteristics
|
American National Standards Institute |
| Food and Drug Administration |
|
21 CFR 801.410(d)(2) |
ASTM D412 |
1968 |
Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension
|
ASTM International |
| Food and Drug Administration |
|
21 CFR 801.410(d)(2) |
ASTM D1415 |
1988 |
Standard Test Method for Rubber Property--International Hardness
|
ASTM International |
| Health and Human Services Department |
87 FR 50698 |
21 CFR 801 |
ANSI ASA S3.22-2014 (R2020) |
2014 |
Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids
|
Acoustical Society of America |
| Health and Human Services Department |
87 FR 50698 |
21 CFR 801 |
ANSI/CTA 2051-2017 |
2017 |
Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids
|
Consumer Technology Association |
| Health and Human Services Department |
87 FR 50698 |
21 CFR 800 |
ANSI ASA S3.22-2014 (R2020) |
2014 |
Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids
|
Acoustical Society of America |
| Health and Human Services Department |
87 FR 50698 |
21 CFR 800 |
CTA 2051-2017 |
2017 |
Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids
|
Consumer Technology Association |
| Food and Drug Administration |
|
21 CFR 73.585(b)(1) |
LNPI S.O.P. number: Lab/119/01, Revision 01 |
2001 |
Qualitative Analysis of Lycopene, Its Isomers and Other Carotenoids in Different Concentrations of Lyc-O-Mato® (Tomato Oleoresin) and in Tomato Pulp by High Performance Liquid Chromatography (HPLC)
|
LycoRed Natural Products Industries |
| Food and Drug Administration |
|
21 CFR 73.450(b) |
Food Chemicals Codex |
1981 |
Riboflavin
|
National Academy Press |
| Food and Drug Administration |
|
21 CFR 73.450(a)(1) |
Food Chemicals Codex |
1981 |
Riboflavin
|
National Academy Press |
| Food and Drug Administration |
|
21 CFR 73.165(b) |
Food Chemicals Codex |
1996 |
Ferrous lactate
|
National Academy Press |
| Food and Drug Administration |
|
21 CFR 73.160(b) |
Food Chemicals Codex |
1981 |
Ferrous Gluconate
|
National Academy Press |
| Food and Drug Administration |
|
21 CFR 73.160(a) |
Food Chemicals Codex |
1981 |
Ferrous Gluconate
|
National Academy Press |
| Health and Human Services Department |
87 FR 58445 |
21 CFR 73 |
CAS 471-34-1 |
2022 |
Listing of Color Additives Exempt From Certification; Calcium Carbonate
|
U.S. Pharmacopeial Convention |
| Health and Human Services Department |
87 FR 58445 |
21 CFR 73 |
FCC 13 : limestone, ground |
2022 |
Listing of Color Additives Exempt From Certification; Calcium Carbonate
|
Food and Drug Administration, U.S. Department of Health and Human Services |
| Food and Drug Administration |
|
21 CFR 701.3(c)(2)(iv) |
Food Chemicals Codex |
1972 |
Food Chemicals Codex, 2nd Edition
|
National Academy Press |
| Food and Drug Administration |
|
21 CFR 701.3(c)(2)(iv) |
Food Chemicals Codex |
1974 |
Food Chemicals Codex, First Supplement
|
National Academy Press |
| Food and Drug Administration |
|
21 CFR 701.3(c)(2)(iv) |
Food Chemicals Codex |
1975 |
Food Chemicals Codex, Second Supplement
|
National Academy Press |
| Food and Drug Administration |
|
21 CFR 701.3(c)(2)(i) |
CTFA Publication |
1977 |
Cosmetic Ingredient Dictionary
|
Cosmetic, Toiletry, and Fragrance Association, Inc. |
| Food and Drug Administration |
|
21 CFR 700.27(a)(6) |
AOAC Method Ca 3a-46 |
1997 |
Insoluble Impurities
|
AOAC International |
| Food and Drug Administration |
|
21 CFR 610.12(f) |
The United States Pharmacopeia |
1995 |
United States Pharmacopeia
|
U.S. Pharmacopeial Convention |
| Food and Drug Administration |
|
21 CFR 573.640(b)(4)(ii) |
AOAC Official Methods |
1975 |
Official Methods of Analysis
|
AOAC International |
| Food and Drug Administration |
|
21 CFR 573.640(b)(4)(ii) |
AOAC Journal |
1961 |
Oils, Fats, and Waxes, Vol. 44, Page 146
|
AOAC International |
| Food and Drug Administration |
|
21 CFR 573.640(b)(4)(i) |
AOAC Official Methods |
1980 |
Official Methods of Analysis
|
AOAC International |
| Food and Drug Administration |
|
21 CFR 573.460(a)(2)(i) |
AAFCO Publication |
2003 |
Official Publication
|
Association of American Feed Control Officials, Inc. |
| Food and Drug Administration |
|
21 CFR 573.460(a)(1)(i) |
AAFCO Publication |
2003 |
Official Publication
|
Association of American Feed Control Officials, Inc. |
| Food and Drug Administration |
|
21 CFR 522.2640(a) |
FDA Publication |
2001 |
Determination of Factor Content in Tylosin by High Performance Liquid Chromatography
|
Food and Drug Administration, U.S. Department of Health and Human Services |
| Food and Drug Administration |
|
21 CFR 522.2640(a) |
FDA Publication |
2012 |
Determination of Factor Content in Tylosin by High Performance Liquid Chromatography
|
Food and Drug Administration, U.S. Department of Health and Human Services |
| Health and Human Services Department |
89 FR 51738 |
21 CFR 514 |
ISO 9000 |
2015 |
Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases
|
International Organization for Standardization |
| Health and Human Services Department |
89 FR 51738 |
21 CFR 514 |
ISO 13485 |
2016 |
Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases
|
International Organization for Standardization |
| Health and Human Services Department |
89 FR 51738 |
21 CFR 4 |
ISO 9000 |
2015 |
Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases
|
International Organization for Standardization |
| Health and Human Services Department |
89 FR 51738 |
21 CFR 4 |
ISO 13485 |
2016 |
Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases
|
International Organization for Standardization |
| Health and Human Services Department |
89 FR 7496 |
21 CFR 4 |
ISO 9000:2015(E), Clause 3 |
2015 |
Medical Devices; Quality System Regulation Amendments
|
International Organization for Standardization |
| Health and Human Services Department |
89 FR 7496 |
21 CFR 4 |
ISO 13485:2016(E) |
2016 |
Medical Devices; Quality System Regulation Amendments
|
International Organization for Standardization |
| Health and Human Services Department |
89 FR 51738 |
21 CFR 314 |
ISO 9000 |
2015 |
Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases
|
International Organization for Standardization |
| Health and Human Services Department |
89 FR 51738 |
21 CFR 314 |
ISO 13485 |
2016 |
Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases
|
International Organization for Standardization |
| Food and Drug Administration |
|
21 CFR 299.4(d) |
USAN and the USP Dictionary of Drug Names |
1985 |
Guiding Principles for Coining U.S. Adopted Names for Drugs
|
U.S. Pharmacopeial Convention |
| Food and Drug Administration |
|
21 CFR 26.60(b) |
ISO Guide 2 |
1996 |
Standardization and Related Activities-General Vocabulary of the ISO and IEC
|
International Organization for Standardization |
| Health and Human Services Department |
89 FR 51738 |
21 CFR 230 |
ISO 9000 |
2015 |
Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases
|
International Organization for Standardization |
| Health and Human Services Department |
89 FR 51738 |
21 CFR 230 |
ISO 13485 |
2016 |
Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases
|
International Organization for Standardization |
| Health and Human Services Department |
89 FR 51738 |
21 CFR 213 |
ISO 9000 |
2015 |
Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases
|
International Organization for Standardization |
| Food and Drug Administration |
|
21 CFR 211.176 |
FDA Publication |
2012 |
Procedures for Detecting and Measuring Penicillin Contamination in Drugs
|
Food and Drug Administration, U.S. Department of Health and Human Services |
| Food and Drug Administration |
|
21 CFR 211.176 |
FDA Publication |
1989 |
Procedures for Detecting and Measuring Penicillin Contamination in Drugs
|
Food and Drug Administration, U.S. Department of Health and Human Services |
| Health and Human Services Department |
89 FR 51738 |
21 CFR 211 |
ISO 9000 |
2015 |
Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases
|
International Organization for Standardization |
| Health and Human Services Department |
89 FR 51738 |
21 CFR 211 |
ISO 13485 |
2016 |
Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases
|
International Organization for Standardization |
| Health and Human Services Department |
89 FR 51738 |
21 CFR 210 |
ISO 13485 |
2016 |
Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases
|
International Organization for Standardization |
| Health and Human Services Department |
89 FR 51738 |
21 CFR 210 |
ISO 9000 |
2015 |
Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases
|
International Organization for Standardization |