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Code of Federal Regulations (Last Updated: May 6, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter A - General |
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Part 5 - Organization |
| Subpart A - Delegations of Authority to the Commissioner of Food and Drugs |
| § 5.10 - Delegations from the Secretary of Health and Human Services to the Commissioner of Food and Drugs. |
| § 5.11 - Reservation of authority. |
| Subparts A--L - XXX |
| Subpart B - General Redelegations of Authority |
| § 5.20 - General redelegations of authority from the Commissioner to other officers of the Food and Drug Administration. |
| § 5.21 - Emergency functions. |
| § 5.22 - Certification of true copies and use of Department seal. |
| § 5.23 - Disclosure of official records and authorization of testimony. |
| § 5.24 - Authority relating to technology transfer. |
| § 5.25 - Research, investigation, and testing programs and health information and promotion programs. |
| § 5.26 - Service fellowships. |
| § 5.27 - Patent term extensions for human drug products, medical devices, and food and color additives; and authority to perform due diligence determinations and informal hearings. |
| § 5.28 - Hearings. |
| § 5.29 - Petitions under part 10. |
| § 5.30 - Authority to select temporary voting members for advisory committees and authority to sign conflict of interest waivers. |
| § 5.31 - Enforcement activities. |
| § 5.32 - Certification following inspections. |
| § 5.33 - Issuance of reports of minor violations. |
| § 5.34 - Issuance of notices relating to proposals and orders for debarment and denial of an application to terminate debarment. |
| § 5.35 - Officials authorized to make certification under 5 U.S.C. 605(b) for any proposed and final rules. |
| § 5.36 - Certification following inspections. |
| § 5.37 - Issuance of reports of minor violations. |
| § 5.39 - Redelegation of the Center for Biologics Evaluation and Research Director's program authorities. |
| § 5.44 - Export of unapproved drugs. |
| § 5.45 - Imports and exports. |
| § 5.46 - Manufacturer's resident import agents. |
| § 5.47 - Detention of adulterated or misbranded medical devices. |
| § 5.49 - Authorization to use alternative evidence for determination of the effectiveness of medical devices. |
| § 5.50 - Notification to petitioners of determinations made on petitions for reclassification of medical devices. |
| § 5.51 - Determination of classification of devices. |
| § 5.52 - Notification to sponsors of deficiencies in petitions for reclassification of medical devices. |
| § 5.53 - Approval, disapproval, or withdrawal of approval of product development protocols and applications for premarket approval for medical devices. |
| § 5.54 - Determinations that medical devices present unreasonable risk of substantial harm. |
| § 5.55 - Orders to repair or replace, or make refunds for, medical devices. |
| § 5.56 - Recall authority. |
| § 5.57 - Temporary suspension of a medical device application. |
| § 5.58 - Orphan products. |
| § 5.59 - Approval, disapproval, or withdrawal of approval of applications for investigational device exemptions. |
| § 5.60 - Required and discretionary postmarket surveillance. |
| § 5.61 - Food standards, food additives, generally recognized as safe (GRAS) substances, color additives, nutrient content claims, and health claims. |
| § 5.62 - Issuance of initial emergency permit orders and notices of confirmation of effective date of final regulations on food for human and animal consumption. |
| § 5.63 - Detention of meat, poultry, eggs, and related products. |
| § 5.64 - Establishing standards and approving accrediting bodies under the National Laboratory Accreditation Program. |
| § 5.66 - Approval of schools providing food-processing instruction. |
| § 5.68 - Issuance and revocation of licenses for the propagation or manufacture and preparation of biological products. |
| § 5.69 - Notification of release for distribution of biological products. |
| § 5.70 - Issuance of notice implementing the provisions of the Drug Amendments of 1962. |
| § 5.71 - Termination of exemptions for new drugs for investigational use in human beings and in animals. |
| § 5.72 - Authority to approve and to withdraw approval of a charge for investigational new drugs. |
| § 5.73 - Certification of insulin. |
| § 5.74 - Issuance, amendment, or repeal of regulations pertaining to drugs containing insulin. |
| § 5.75 - Designation of official master and working standards for antibiotic drugs. |
| § 5.76 - Certification of antibiotic drugs. |
| § 5.78 - Issuance, amendment, or repeal of regulations pertaining to antibiotic drugs. |
| § 5.80 - Approval of new drug applications and their supplements. |
| § 5.81 - Responses to Drug Enforcement Administration temporaryscheduling notices. |
| § 5.82 - Issuance of notices relating to proposals to refuse approval or to withdraw approval of new drug applications and their supplements. |
| § 5.83 - Approval of new animal drug applications, medicated feed mill license applications and their supplements. |
| § 5.84 - Issuance of notices, proposals, and orders relating to new animal drugs and medicated feed mill license applications. |
| § 5.85 - Authority to ensure that mammography facilities meet quality standards. |
| § 5.86 - Variances from performance standards for electronic products. |
| § 5.87 - Exemption of electronic products from performance standards and prohibited acts. |
| § 5.88 - Testing programs and methods of certification and identification for electronic products. |
| § 5.89 - Notification of defects in, and repair or replacement of, electronic products. |
| § 5.90 - Manufacturers requirement to provide data to ultimate purchasers of electronic products. |
| § 5.91 - Dealer and distributor direction to provide data to manufacturers of electronic products. |
| § 5.92 - Acceptance of assistance from State and local authorities for enforcement of radiation control legislation and regulations. |
| § 5.93 - Submission of and effective approval dates for abbreviated new drug applications and certain new drug applications. |
| § 5.94 - Extensions or stays of effective dates for compliance with certain labeling requirements for human prescription drugs. |
| § 5.95 - Submission of and effective approval dates for abbreviated new animal drug applications and certain new animal drug applications. |
| § 5.98 - Authority relating to medical device reporting procedures. |
| § 5.99 - Issuance of notices relating to proposals and orders for debarment and denial of an application to terminate debarment. |
| Subpart C - Human Drugs; Redelegations of Authority |
| § 5.100 - Issuance of notices implementing the provisions of the Drug Amendments of 1962. |
| § 5.101 - Termination of exemptions for new drugs for investigational use in human beings. |
| § 5.102 - Authority to approve and to withdraw approval of a charge for investigational new drugs. |
| § 5.103 - Approval of new drug applications and their supplements. |
| § 5.104 - Responses to Drug Enforcement Administration temporary scheduling notices. |
| § 5.105 - Issuance of notices relating to proposals to refuse approval or to withdraw approval of new drug applications and their supplements. |
| § 5.106 - Submission of and effective approval dates for abbreviated new drug applications and certain new drug applications. |
| § 5.107 - Extensions or stays of effective dates for compliance with certain labeling requirements for human prescription drugs. |
| § 5.108 - Authority relating to waivers or reductions of prescription drug user fees. |
| § 5.109 - Issuance of written notices concerning patent information, current good manufacturing practices and false or misleading labeling of new drugs. |
| § 5.205 - Chief Counsel, Food and Drug Administration. |
| § 5.210 - FDA Public Information Offices. |
| § 5.215 - Field structure. |
| Subpart D - Biologics; Redelegations of Authority |
| § 5.200 - Functions pertaining to safer vaccines. |
| § 5.201 - Redelegation of the Center for Biologics Evaluation and Research Director's program authorities. |
| § 5.203 - Issuance and revocation of licenses for the propagation or manufacture and preparation of biological products. |
| § 5.204 - Notification of release for distribution of biological products. |
| Subpart E - Food and Cosmetics; Redelegations of Authority |
| § 5.300 - Food standards, food additives, generally recognized as safe (GRAS) substances, color additives, nutrient content claims, and health claims. |
| § 5.301 - Issuance of initial emergency permit orders and notices of confirmation of effective date of final regulations on food for human and animal consumption. |
| § 5.302 - Detention of meat, poultry, eggs, and related products. |
| § 5.303 - Establishing standards and approving accrediting bodies under the National Laboratory Accreditation Program. |
| § 5.304 - Approval of schools providing food-processing instruction. |
| Subpart F - Medical Devices and Radiological Health; Redelegations of Authority |
| § 5.400 - Issuance of Federal Register documents to recognize or to withdraw recognition of a standard to meet premarket submission requirements. |
| § 5.401 - Issuance of Federal Register documents pertaining to exemptions from premarket notification. |
| § 5.402 - Detention of adulterated or misbranded medical devices. |
| § 5.403 - Authorization to use alternative evidence for determination of the effectiveness of medical devices. |
| § 5.404 - Notification to petitioners of determinations made on petitions for reclassification of medical devices. |
| § 5.405 - Determination of classification of devices. |
| § 5.406 - Notification to sponsors of deficiencies in petitions for reclassification of medical devices. |
| § 5.407 - Approval, disapproval, or withdrawal of approval of product development protocols and applications for premarket approval for medical devices. |
| § 5.408 - Determinations concerning the type of valid scientific evidence submitted in a premarket approval application. |
| § 5.409 - Determinations that medical devices present unreasonable risk of substantial harm. |
| § 5.410 - Orders to repair or replace, or make refunds for, medical devices. |
| § 5.411 - Medical device recall authority. |
| § 5.412 - Temporary suspension of a medical device application. |
| § 5.413 - Approval, disapproval, or withdrawal of approval of applications and entering into agreements for investigational device exemptions. |
| § 5.414 - Postmarket surveillance. |
| § 5.415 - Authority relating to medical device reporting procedures. |
| § 5.416 - Medical device tracking. |
| § 5.417 - Authority pertaining to accreditation functions for medical devices. |
| Subpart G - Animal Drugs; Redelegations of Authority |
| § 5.501 - Approval of new animal drug applications, medicated feed mill license applications and their supplements. |
| § 5.502 - Issuance of notices, proposals, and orders relating to new animal drugs and medicated feed mill license applications. |
| § 5.503 - Submission of and effective approval dates for abbreviated new animal drug applications and certain new animal drug applications. |
| § 5.505 - Termination of exemptions for new drugs for investigational use in animals. |
| Subpart H - Radiation Control; Redelegations of Authority |
| § 5.600 - Variances from performance standards for electronic products. |
| § 5.601 - Exemption of electronic products from performance standards and prohibited acts. |
| § 5.602 - Testing programs and methods of certification and identification for electronic products. |
| § 5.603 - Notification of defects in, and repair or replacement of, electronic products. |
| § 5.604 - Manufacturers requirement to provide data to ultimate purchasers of electronic products. |
| § 5.605 - Dealer and distributor direction to provide data to manufacturers of electronic products. |
| § 5.606 - Acceptance of assistance from State and Local authorities for enforcement of radiation control legislation and regulations. |
| Subpart I - Product Designation; Redelegations of Authority |
| § 5.700 - Authority relating to determination of product primary jurisdiction. |
| § 5.701 - Premarket approval of a product that is or contains a biologic, a device, or a drug. |
| Subpart J - Imports and Exports; Redelegations of Authority |
| § 5.800 - Imports and exports. |
| § 5.801 - Export of unapproved drugs. |
| § 5.802 - Manufacturer's resident import agents. |
| Subpart K - Orphan Products; Redelegations of Authority |
| § 5.900 - Orphan products. |
| Subpart L - Mammography Facilities; Redelegations of Authority |
| § 5.1000 - Authority to ensure that mammography facilities meet quality standards. |
| Subpart M - Organization |
| § 5.1100 - Headquarters. |
| § 5.1105 - Chief Counsel, Food and Drug Administration. |
| § 5.1110 - FDA public information offices. |
| § 5.1115 - Field structure. |