21 CFR Subpart R - Subpart R—Laboratory Accreditation for Analyses of Foods
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General Provisions (§§ 1.1101 - 1.1103)
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General Requirements (§§ 1.1107 - 1.1110)
- § 1.1107 When must food testing be conducted under this subpart?
- § 1.1108 When and how will FDA issue a directed food laboratory order?
- § 1.1109 How will FDA make information about recognized accreditation bodies and LAAF-accredited laboratories available to the public?
- § 1.1110 What are the general requirements for submitting information to FDA under this subpart?
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FDA Recognition of Accreditation Bodies (§§ 1.1113 - 1.1117)
- § 1.1113 What are the eligibility requirements for a recognized accreditation body?
- § 1.1114 How does an accreditation body apply to FDA for recognition or renewal of recognition?
- § 1.1115 How will FDA evaluate applications for recognition and renewal of recognition?
- § 1.1116 What must a recognized accreditation body do to voluntarily relinquish or not renew its recognition?
- § 1.1117 How may an accreditation body request reinstatement of recognition?
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Requirements for Recognized Accreditation Bodies (§§ 1.1119 - 1.1125)
- § 1.1119 What are the conflict of interest requirements for a recognized accreditation body?
- § 1.1120 How must a recognized accreditation body assess laboratories seeking LAAF-accreditation and oversee LAAF-accredited laboratories?
- § 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?
- § 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?
- § 1.1123 What reports, notifications, and documentation must a recognized accreditation body submit to FDA?
- § 1.1124 What are the records requirements for a recognized accreditation body?
- § 1.1125 What are the internal audit requirements for a recognized accreditation body?
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FDA Oversight of Recognized Accreditation Bodies (§§ 1.1130 - 1.1131)
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LAAF-Accreditation of Laboratories (§§ 1.1138 - 1.1142)
- § 1.1138 What are the eligibility requirements for a LAAF-accredited laboratory?
- § 1.1139 How does a laboratory apply for LAAF-accreditation or extend its scope of LAAF-accreditation?
- § 1.1140 What must a LAAF-accredited laboratory do to voluntarily relinquish its LAAF-accreditation?
- § 1.1141 What is the effect on a LAAF-accredited laboratory if its recognized accreditation body is no longer recognized by FDA?
- § 1.1142 How does a laboratory request reinstatement of LAAF-accreditation?
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Requirements for LAAF-Accredited Laboratories (§§ 1.1147 - 1.1154)
- § 1.1147 What are the impartiality and conflict of interest requirements for a LAAF-accredited laboratory?
- § 1.1149 What oversight standards apply to sampling?
- § 1.1150 What are the requirements for analysis of samples by a LAAF-accredited laboratory?
- § 1.1151 What requirements apply to the methods of analysis a LAAF-accredited laboratory uses to conduct food testing under this subpart?
- § 1.1152 What notifications, results, reports, and studies must a LAAF-accredited laboratory submit to FDA?
- § 1.1153 What are the requirements for submitting abridged analytical reports?
- § 1.1154 What other records requirements must a LAAF-accredited laboratory meet?
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FDA Oversight of LAAF-Accredited Laboratories (§§ 1.1159 - 1.1162)
- § 1.1159 How will FDA oversee LAAF-accredited laboratories?
- § 1.1160 How will FDA review test results and analytical reports?
- § 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?
- § 1.1162 What are the consequences if FDA puts a LAAF-accredited laboratory on probation or disqualifies a LAAF-accredited laboratory?
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Requesting FDA Reconsideration or Regulatory Hearings of FDA Decisions Under This Subpart (§§ 1.1171 - 1.1174)
- § 1.1171 How does an accreditation body request reconsideration by FDA of a decision to deny its application for recognition, renewal, or reinstatement?
- § 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?
- § 1.1174 How does an owner or consignee request a regulatory hearing on a directed food laboratory order?
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Electronic Records and Public Disclosure Requirements (§§ 1.1199 - 1.1200)
Source:
86 FR 68817, Dec. 3, 2021; 87 FR 5660, Feb. 2, 2022, unless otherwise noted.