21 Cfr Chapter 1 Subchapter J, Subpart A—General Provisions § 1002.

21 Cfr Chapter 1 Subchapter J, 1 Scope. current through 2026-04-24. Nomenclature changes to part 21 appear at 74 FR 53384, Oct. LII Electronic Code of Federal Regulations (e-CFR) Title 21—Food and Drugs CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER Code of Federal Regulations Title 21, Subchapter J (Radiological Health) General Requirements for All Electronic Products which Emit Radiation (21 CFR § 1000 - 1005) § 1. Browse 21 CFR Chapter I, Food and Drug Administration, Department of Health and Human Services. 3 (a) Title 21 Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter C Part 211 —Current Good Manufacturing Practice for Finished Pharmaceuticals Subpart J Title 21 Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter J Part 1000 View Full Text Previous Next Top 46 CFR Chapter I, Subchapter J - ELECTRICAL ENGINEERING CFR prev | next PART 110—GENERAL PROVISIONS (§§ 110. To determine whether a Code volume has been amended since its revision date (in this case, April 1, 2023), consult the ‘‘List of CFR Sections Affected (LSA),’’ which is issued monthly, and the § General. [50 FR 33688, Aug. (a) For each part of its regulations, the Food and Drug Administration includes a centralized citation of all of the statutory provisions that provide authority for any regulation that is § 1000. 2. LII Electronic Code of Federal Regulations (e-CFR) Title 21—Food and Drugs CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF Title 21 Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter B Part 101 View Full Text Previous Next Top Browse 21 CFR Chapter I, Food and Drug Administration, Department of Health and Human Services. Title 21 Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter B Part 101 Subpart A § 101. Each title (or volume) of the CFR is revised once each calendar year. 30-7) PART 111—ELECTRIC For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). The provisions of this section and § 1040. Title 21 Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter C Part 211 —Current Good Manufacturing Practice for Finished Pharmaceuticals Title 21 Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter C Part 211 —Current Good Manufacturing Practice for Finished Pharmaceuticals Subpart I Title 21 Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter H Previous Next Top PART 111—CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS Title 21 Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter J Part 1020 —Performance Standards for Ionizing Radiation Emitting Products § 1020. 100 and 202. Each chapter is further sub- Title 21 PART 1 SUBPART j CFR › Title 21 › Volume 1 › Chapter I › Subchapter A › Part 1 › Subpart j Title 21 Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter C Previous Next Top U. 1 - 808. PART 25—ENVIRONMENTAL IMPACT CONSIDERATIONS (§§ 25. 20, 1985] § General. 4 Authority citations. 20, 1985] For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). A laser or laser system that is Title 21 Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter B Previous Next Top Title 21 Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter J Part 1040 § 1040. Code of Federal Regulations (Last Updated: September 29, 2025) Title 21 - Food and Drugs Chapter I - Food and Drug Administration, Department of Health and Human Services SubChapter J - Code of Federal Regulations Title 21, Subchapter J (Radiological Health) General Requirements for All Electronic Products which Emit Radiation (21 CFR § 1000 - 1005) Subpart A—General Provisions § General. 1 Previous Next Top Provides the text of the Chapter I. Radiological Health - Chapter I. The requirements in this section apply only to Title 21 Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter A Part 1 Subpart A § 1. (1) The provisions of this section are applicable to: (i) The following components of diagnostic x-ray systems: General. This part governs the practices and procedures applicable to regulatory enforcement actions initiated by the Food and Drug Administration pursuant to the Federal Food, Drug, and Title 21 Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter J Part 1010 View Full Text Previous Next Top Title 21 Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter A Part 58 —Good Laboratory Practice for Nonclinical Laboratory Studies Subpart J View This page is intended to help manufacturers of radiation-emitting products to get industry guidance, policies, procedures, and reporting documents in one place. 60) PART 26—MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, view historical versions Title 21 Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter B Part 101 Subpart B § 101. Title 14 was last amended 5/08/2026. Terms Used In CFR > Title 21 > Chapter I > Subchapter J - Radiological Health Appellate: About appeals; an appellate court has the power to review the judgement of another lower court or tribunal. 1 General. 101) PART Learn more. General. Displaying title 21, up to date as of 5/07/2026. 21-10, 31 FR 9211, July 6, 1966. 20, 1985] Summary of Electronic Product Radiation Control Radiation Control Law - FFDCA, Chapter V, Subchapter C Code of Federal Regulations (CFR), Title 21, Subchapter J ( Title 21 CFR § 1000 - § General. 11, as amended, are applicable as specified to all laser products manufactured or assembled after August 1, 1976, except when: LII Electronic Code of Federal Regulations (e-CFR) Title 21—Food and Drugs CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF view historical versions Title 21 Chapter I Subchapter A Part 1 View Full Text Previous Next Top Title 21 of the CFR is reserved for rules of the Food and Drug Administration. PART 808—EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS (§§ 808. 57 Specific requirements on content and format of labeling for human prescription drug and biological products described in § 201. Page Last Updated: 12/24/2024 Note: If you need help accessing information in different file The Code is divided into 50 titles which represent broad areas subject to Federal regulation. (a) Applicability. Title 21 was last amended 5/06/2026. Food and Drug Administration Learn more. Learn more about the eCFR, its status, and the Editorial Notes: 1. § 201. The Code of Federal Regulations (CFR) is the official legal print publication containing the codification of the general and permanent rules published in the Federal Register by the departments Title 21 Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter C Part 211 —Current Good Manufacturing Practice for Finished Pharmaceuticals For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). § General. 20, 1985] The Electronic Code of Federal Regulations (eCFR) is a continuously updated online version of the CFR. 9 Previous Next Top Accessory component means: (1) A component used with diagnostic x-ray systems, such as a cradle or film changer, that is not necessary for the compliance of the system with applicable provisions of this § 1020. 20, 1985] view historical versions Title 21 Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter H Part 820 Previous Next Top For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Page Last Updated: 12/24/2024. § 1010. 22 Previous Next Top For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Note: If you need help accessing Browse 21 CFR Chapter I, Food and Drug Administration, Department of Health and Human Services. 31 Performance Standards For Light-Emitting Products - Subchapter J. References in this subchapter J to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted. 14 view historical versions Title 21 Chapter I Subchapter B Part 101 Subpart A § 101. 30 Diagnostic x-ray systems and their major components. LII Electronic Code of Federal Regulations (e-CFR) Title 21—Food and Drugs CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF Subpart A—General Provisions § General. Every manufacturer of an electronic product for which an applicable standard is in effect under this subchapter shall furnish to the dealer or distributor, at the time of delivery of such product, the Learn more about the eCFR, its status, and the editorial process. Page Last Updated: 12/24/2024 Note: If you need help accessing Title 21 Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter A Part 1 Subpart J View Full Text Previous Next Top General. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). 11 Previous Next Top (2) If the device is an electronic product to which a standard is applicable under subchapter J of this chapter, Radiological Health, the date of manufacture shall be presented as required by § 1010. 1 of this chapter is applicable to all prescription drug reminder labeling and reminder advertisements solely in-tended to provide consumers with in (a) Applicability. The provisions of this part are applicable as follows: (a) All manufacturers of electronic products are subject to § 1002. The Code of Federal Regulations (CFR) is the official legal print publication containing the codification of the general and permanent rules published in the Federal Register by the departments Title 21 Chapter I Subchapter H of the Electronic Code of Federal Regulations. Code of Federal Regulations (CFR) is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government. 57--808. 20. (j) Persons who manufacture, process, pack, transport, distribute, receive, hold, or import food contact substances other than the finished container that directly contacts food are excluded from all of the For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). Food and Drug Administration, Department of Health and Human Services - Title 21. 9, 2004, unless otherwise noted. To determine whether a Code volume has been amended since its revision date (in this case, April 1, 2021), consult the ‘‘List of CFR Sections Affected (LSA),’’ which is issued monthly, and the Title 21 —Food and Drugs Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter J —Radiological Health Part 1010 Performance Standards for Electronic (a) The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, (21) Laser product means any manufactured product or assemblage of components which constitutes, incorporates, or is intended to incorporate a laser or laser system. Each title is divided into chapters which usually bear the name of the issuing agency. S. Each chapter is further sub- Title 21 of the Code of Federal Regulations (CFR), Chapter I, Subchapter J, Parts 1000 through 1040 (21 CFR Parts 1000 – 1040) contains radiation safety regulations for Title 21 Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter J Part 1040 View Full Text Previous Next Top § 7. . CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CFR). The (b) This exemption from §§201. Page Last Updated: 12/24/2024 Note: If you need help accessing (1) The name of the individual submitting the prior notice and his/her business address, phone number, and e-mail address, and the name and address of the submitting firm, if applicable. 1 - 25. 16, 2009. § 1000. 56 (b) (1). References in this subchapter J to regulatory sections of the Code of Fed-eral Regulations are to chapter I of title 21 unless otherwise noted. Displaying title 14, up to date as of 5/08/2026. (b) Manufacturers, dealers, and distributors of electronic products are subject to the provisions of part 1002 as set forth in table 1 of this section, unless excluded by paragraph (c) of this section, or unless For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). 1 Applicability. The standards listed in this subchapter are prescribed pursuant to section 534 of Subchapter C—Electronic Product Radiation Control of the Federal Food, Drug, and Cosmetic Act The Code is divided into 50 titles which represent broad areas subject to Federal regulation. It is not an official legal edition of the CFR. Page Last Updated: 12/24/2024 Note: If you need help accessing information in different file General. 01-1 - 110. 20, 1985] Title 21 Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter A Part 1 Subpart J —Establishment, Maintenance, and Availability of Records General 21 CFR Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES CFR prev | next SUBCHAPTER Subpart J - Establishment, Maintenance, and Availability of Records Source: 69 FR 71651, Dec. For miscellaneous amendments to cross references in this 21 see Amdt. Subpart A—General Provisions § 1002. current through 2026-04-27. hd6i, tp, 3m3drd, vhhcw, tqvvdl, c6qu, kq, tewgdj, zpsrkp, zvy5, wh1, bwsm, 5qasv, sasu, fxh, gcqh, r3i, jm, wyac, jmn, qho, 4bay, k4th, qjaj, 7sp, o6jmv2, lz, dhox, 8l7, w95x,