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- 21 CFR 1.1102 · What definitions apply to this subpart?
- 21 CFR 1.1103 · Who is subject to this subpart?
- 21 CFR 1.1107 · When must food testing be conducted under this subpart?
- 21 CFR 1.1108 · When and how will FDA issue a directed food laboratory order?
- 21 CFR 1.1109 · How will FDA make information about recognized accreditation bodies and LAAF-accredited laboratories available to the public?
- 21 CFR 1.1110 · What are the general requirements for submitting information to FDA under this subpart?
- 21 CFR 1.1113 · What are the eligibility requirements for a recognized accreditation body?
- 21 CFR 1.1114 · How does an accreditation body apply to FDA for recognition or renewal of recognition?
- 21 CFR 1.1115 · How will FDA evaluate applications for recognition and renewal of recognition?
- 21 CFR 1.1116 · What must a recognized accreditation body do to voluntarily relinquish or not renew its recognition?
- 21 CFR 1.1117 · How may an accreditation body request reinstatement of recognition?
- 21 CFR 1.1119 · What are the conflict of interest requirements for a recognized accreditation body?
- 21 CFR 1.1120 · How must a recognized accreditation body assess laboratories seeking LAAF-accreditation and oversee LAAF-accredited laboratories?
- 21 CFR 1.1121 · When must a recognized accreditation body require corrective action, suspend a LAAF-accredited laboratory, or reduce the scope of or withdraw the LAAF-accreditation of a laboratory?
- 21 CFR 1.1122 · What procedures must a recognized accreditation body provide for appeals of decisions to suspend, reduce the scope of, withdraw, or deny LAAF-accreditation?
- 21 CFR 1.1123 · What reports, notifications, and documentation must a recognized accreditation body submit to FDA?
- 21 CFR 1.1124 · What are the records requirements for a recognized accreditation body?
- 21 CFR 1.1125 · What are the internal audit requirements for a recognized accreditation body?
- 21 CFR 1.1130 · How will FDA oversee recognized accreditation bodies?
- 21 CFR 1.1131 · When will FDA require corrective action, put a recognized accreditation body on probation, or revoke the recognition of an accreditation body?
- 21 CFR 1.1138 · What are the eligibility requirements for a LAAF-accredited laboratory?
- 21 CFR 1.1139 · How does a laboratory apply for LAAF-accreditation or extend its scope of LAAF-accreditation?
- 21 CFR 1.1140 · What must a LAAF-accredited laboratory do to voluntarily relinquish its LAAF-accreditation?
- 21 CFR 1.1141 · What is the effect on a LAAF-accredited laboratory if its recognized accreditation body is no longer recognized by FDA?
- 21 CFR 1.1142 · How does a laboratory request reinstatement of LAAF-accreditation?
- 21 CFR 1.1147 · What are the impartiality and conflict of interest requirements for a LAAF-accredited laboratory?
- 21 CFR 1.1149 · What oversight standards apply to sampling?
- 21 CFR 1.1150 · What are the requirements for analysis of samples by a LAAF-accredited laboratory?
- 21 CFR 1.1151 · What requirements apply to the methods of analysis a LAAF-accredited laboratory uses to conduct food testing under this subpart?
- 21 CFR 1.1152 · What notifications, results, reports, and studies must a LAAF-accredited laboratory submit to FDA?
- 21 CFR 1.1153 · What are the requirements for submitting abridged analytical reports?
- 21 CFR 1.1154 · What other records requirements must a LAAF-accredited laboratory meet?
- 21 CFR 1.1159 · How will FDA oversee LAAF-accredited laboratories?
- 21 CFR 1.1160 · How will FDA review test results and analytical reports?
- 21 CFR 1.1161 · When will FDA require corrective action, put a LAAF-accredited laboratory on probation, or disqualify a LAAF-accredited laboratory from submitting analytical reports?
- 21 CFR 1.1162 · What are the consequences if FDA puts a LAAF-accredited laboratory on probation or disqualifies a LAAF-accredited laboratory?
- 21 CFR 1.1171 · How does an accreditation body request reconsideration by FDA of a decision to deny its application for recognition, renewal, or reinstatement?
- 21 CFR 1.1173 · How does an accreditation body or laboratory request a regulatory hearing on FDA's decision to revoke the accreditation body's recognition or disqualify a LAAF-accredited laboratory?
- 21 CFR 1.1174 · How does an owner or consignee request a regulatory hearing on a directed food laboratory order?
- 21 CFR 1.1199 · Are electronic records created under this subpart subject to the electronic records requirements of part 11 of this chapter?
- 21 CFR 1.1200 · Are the records obtained by FDA under this subpart subject to public disclosure?
- 21 CFR 1.1300 · Who is subject to this subpart?
- 21 CFR 1.1305 · What foods and persons are exempt from this subpart?
- 21 CFR 1.1310 · What definitions apply to this subpart?
- 21 CFR 1.1315 · What traceability plan must I have for foods on the Food Traceability List that I manufacture, process, pack, or hold?
- 21 CFR 1.1320 · When must I assign traceability lot codes to foods on the Food Traceability List?
- 21 CFR 1.1325 · What records must I keep and provide when I harvest or cool a raw agricultural commodity on the Food Traceability List?
- 21 CFR 1.1330 · What records must I keep when I am performing the initial packing of a raw agricultural commodity (other than a food obtained from a fishing vessel) on the Food Traceability List?
- 21 CFR 1.1335 · What records must I keep when I am the first land-based receiver of a food on the Food Traceability List that was obtained from a fishing vessel?
- 21 CFR 1.1340 · What records must I keep and provide when I ship a food on the Food Traceability List?
- 21 CFR 1.1345 · What records must I keep when I receive a food on the Food Traceability List?
- 21 CFR 1.1350 · What records must I keep when I transform a food on the Food Traceability List?
- 21 CFR 1.1360 · Under what circumstances will FDA modify the requirements in this subpart that apply to a food or type of entity or exempt a food or type of entity from the requirements of this subpart?
- 21 CFR 1.1365 · When will FDA consider whether to adopt modified requirements or grant an exemption from the requirements of this subpart?
- 21 CFR 1.1370 · What must be included in a petition requesting modified requirements or an exemption from the requirements?
- 21 CFR 1.1375 · What information submitted in a petition requesting modified requirements or an exemption, or information in comments on such a petition, is publicly available?
- 21 CFR 1.1380 · What process applies to a petition requesting modified requirements or an exemption?
- 21 CFR 1.1385 · What process will FDA follow when adopting modified requirements or granting an exemption on our own initiative?
- 21 CFR 1.1390 · When will modified requirements that we adopt or an exemption that we grant become effective?
- 21 CFR 1.1395 · Under what circumstances may FDA revise or revoke modified requirements or an exemption?
- 21 CFR 1.1400 · What procedures apply if FDA tentatively determines that modified requirements or an exemption should be revised or revoked?
- 21 CFR 1.1405 · Under what circumstances will FDA waive one or more of the requirements of this subpart for an individual entity or a type of entity?
- 21 CFR 1.1410 · When will FDA consider whether to waive a requirement of this subpart?
- 21 CFR 1.1415 · How may I request a waiver for an individual entity?
- 21 CFR 1.1420 · What process applies to a request for a waiver for an individual entity?
- 21 CFR 1.1425 · What must be included in a petition requesting a waiver for a type of entity?
- 21 CFR 1.1430 · What information submitted in a petition requesting a waiver for a type of entity, or information in comments on such a petition, is publicly available?
- 21 CFR 1.1435 · What process applies to a petition requesting a waiver for a type of entity?
- 21 CFR 1.1440 · What process will FDA follow when waiving a requirement of this subpart on our own initiative?
- 21 CFR 1.1445 · Under what circumstances may FDA modify or revoke a waiver?
- 21 CFR 1.1450 · What procedures apply if FDA tentatively determines that a waiver should be modified or revoked?
- 21 CFR 1.1455 · How must records required by this subpart be maintained and made available?
- 21 CFR 1.1460 · What consequences could result from failing to comply with the requirements of this subpart?
- 21 CFR 1.1465 · How will FDA update the Food Traceability List?
- 21 CFR 2.5 · Imminent hazard to the public health.
- 21 CFR 2.10 · Examination and investigation samples.
- 21 CFR 2.19 · [Reserved]
- 21 CFR 2.25 · Grain seed treated with poisonous substances; color identification to prevent adulteration of human and animal food.
- 21 CFR 2.35 · Use of secondhand containers for the shipment or storage of food and animal feed.
- 21 CFR 2.110 · Definition of ammonia under Federal Caustic Poison Act.
- 21 CFR 2.125 · Use of ozone-depleting substances in foods, drugs, devices, or cosmetics.
- 21 CFR 3.1 · Purpose.
- 21 CFR 3.2 · Definitions.
- 21 CFR 3.3 · Scope.
- 21 CFR 3.4 · Designated agency component.
- 21 CFR 3.5 · Procedures for identifying the designated agency component.
- 21 CFR 3.6 · Product jurisdiction officer.
- 21 CFR 3.7 · Request for designation.
- 21 CFR 3.8 · Letter of designation.
- 21 CFR 3.9 · Effect of letter of designation.
- 21 CFR 3.10 · Stay of review time.
- 21 CFR 4.1 · What is the scope of this subpart?
- 21 CFR 4.2 · How does FDA define key terms and phrases in this subpart?
- 21 CFR 4.3 · What current good manufacturing practice requirements apply to my combination product?
- 21 CFR 4.4 · How can I comply with these current good manufacturing practice requirements for a co-packaged or single-entity combination product?
- 21 CFR 4.100 · What is the scope of this subpart?
- 21 CFR 4.101 · How does the FDA define key terms and phrases in this subpart?
- 21 CFR 4.102 · What reports must you submit to FDA for your combination product or constituent part?
- 21 CFR 4.103 · What information must you share with other constituent part applicants for the combination product?
- 21 CFR 4.104 · How and where must you submit postmarketing safety reports for your combination product or constituent part?