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CFR sections cited by the FDA

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Continuing the CFR sections cited by the FDA list, 1000 records per page, after 312.61.

  1. 312.62(a)§ 312.62 Investigator recordkeeping and record retention.
  2. 312.62(b)§ 312.62 Investigator recordkeeping and record retention.
  3. 312.62(c)§ 312.62 Investigator recordkeeping and record retention.
  4. 312.64(a)§ 312.64 Investigator reports.
  5. 312.64(b)§ 312.64 Investigator reports.
  6. 312.64(c)§ 312.64 Investigator reports.
  7. 312.64(d)§ 312.64 Investigator reports.
  8. 312.66§ 312.66 Assurance of IRB review.
  9. 312.68§ 312.68 Inspection of investigator's records and reports.
  10. 312.69§ 312.69 Handling of controlled substances.
  11. 312.6(a)§ 312.6 Labeling of an investigational new drug.
  12. 312.6(b)§ 312.6 Labeling of an investigational new drug.
  13. 312.7(a)§ 312.7 Promotion of investigational drugs.
  14. 312.7(b)§ 312.7 Promotion of investigational drugs.
  15. 312.8(a)(3)§ 312.8 Charging for investigational drugs under an IND.
  16. 314.80(b)§ 314.80 Postmarketing reporting of adverse drug experiences.
  17. 314.80(c)§ 314.80 Postmarketing reporting of adverse drug experiences.
  18. 314.80(c)(1)(i)§ 314.80 Postmarketing reporting of adverse drug experiences.
  19. 314.80(c)(1)(ii)§ 314.80 Postmarketing reporting of adverse drug experiences.
  20. 314.80(c)(1)(iii)§ 314.80 Postmarketing reporting of adverse drug experiences.
  21. 314.80(c)(1)(iv)
  22. 314.80(c)(2)§ 314.80 Postmarketing reporting of adverse drug experiences.
  23. 314.80(c)(2)(ii)(A)§ 314.80 Postmarketing reporting of adverse drug experiences.
  24. 314.80(c)(2)(ii)(B)§ 314.80 Postmarketing reporting of adverse drug experiences.
  25. 314.80(d)§ 314.80 Postmarketing reporting of adverse drug experiences.
  26. 314.80(e)§ 314.80 Postmarketing reporting of adverse drug experiences.
  27. 314.80(e)(2)
  28. 314.80(f)(1)§ 314.80 Postmarketing reporting of adverse drug experiences.
  29. 314.80(f)(2)§ 314.80 Postmarketing reporting of adverse drug experiences.
  30. 314.80(f)(4)§ 314.80 Postmarketing reporting of adverse drug experiences.
  31. 314.80(g)(1)§ 314.80 Postmarketing reporting of adverse drug experiences.
  32. 314.80(j)§ 314.80 Postmarketing reporting of adverse drug experiences.
  33. 314.81(b)(1)(i)§ 314.81 Other postmarketing reports.
  34. 314.81(b)(1)(ii)§ 314.81 Other postmarketing reports.
  35. 314.81(b)(2)§ 314.81 Other postmarketing reports.
  36. 314.81(b)(2)(i)§ 314.81 Other postmarketing reports.
  37. 314.81(b)(2)(ii)§ 314.81 Other postmarketing reports.
  38. 314.81(b)(2)(iii)§ 314.81 Other postmarketing reports.
  39. 314.81(b)(2)(iv)(a)§ 314.81 Other postmarketing reports.
  40. 314.81(b)(2)(iv)(b)§ 314.81 Other postmarketing reports.
  41. 314.81(b)(2)(vi)(b)§ 314.81 Other postmarketing reports.
  42. 314.81(b)(2)(vii)§ 314.81 Other postmarketing reports.
  43. 314.81(b)(2)(vii)(a)§ 314.81 Other postmarketing reports.
  44. 314.81(b)(2)(viii)§ 314.81 Other postmarketing reports.
  45. 314.98(b)§ 314.98 Postmarketing reports.
  46. 329.100(c)(1)§ 329.100 Postmarketing reporting of adverse drug events under section 760 of the Federal…
  47. 361.1(b)(3)(i)§ 361.1 Radioactive drugs for certain research uses.
  48. 361.1(c)(1)(ii)§ 361.1 Radioactive drugs for certain research uses.
  49. 361.1(c)(2)§ 361.1 Radioactive drugs for certain research uses.
  50. 361.1(c)(3)§ 361.1 Radioactive drugs for certain research uses.
  51. 361.1(d)(1)(iv)§ 361.1 Radioactive drugs for certain research uses.
  52. 361.1(d)(5)§ 361.1 Radioactive drugs for certain research uses.
  53. 361.1(d)(6)§ 361.1 Radioactive drugs for certain research uses.
  54. 361.1(d)(7)§ 361.1 Radioactive drugs for certain research uses.
  55. 361.1(d)(9)§ 361.1 Radioactive drugs for certain research uses.
  56. 361.1(f)(1)§ 361.1 Radioactive drugs for certain research uses.
  57. 361.1(f)(11)§ 361.1 Radioactive drugs for certain research uses.
  58. 361.1(f)(12)§ 361.1 Radioactive drugs for certain research uses.
  59. 361.1(f)(2)§ 361.1 Radioactive drugs for certain research uses.
  60. 361.1(f)(4)§ 361.1 Radioactive drugs for certain research uses.
  61. 361.1(f)(5)§ 361.1 Radioactive drugs for certain research uses.
  62. 361.1(f)(9)§ 361.1 Radioactive drugs for certain research uses.
  63. 50.20§ 50.20 General requirements for informed consent.
  64. 50.23(a)§ 50.23 Exception from general requirements.
  65. 50.24(a)(1)§ 50.24 Exception from informed consent requirements for emergency research.
  66. 50.24(a)(2)§ 50.24 Exception from informed consent requirements for emergency research.
  67. 50.24(a)(3)§ 50.24 Exception from informed consent requirements for emergency research.
  68. 50.24(a)(4)§ 50.24 Exception from informed consent requirements for emergency research.
  69. 50.24(a)(5)§ 50.24 Exception from informed consent requirements for emergency research.
  70. 50.24(a)(6)§ 50.24 Exception from informed consent requirements for emergency research.
  71. 50.24(a)(7)§ 50.24 Exception from informed consent requirements for emergency research.
  72. 50.24(e)§ 50.24 Exception from informed consent requirements for emergency research.
  73. 50.25(a)(1)§ 50.25 Elements of informed consent.
  74. 50.25(a)(2)§ 50.25 Elements of informed consent.
  75. 50.25(a)(3)§ 50.25 Elements of informed consent.
  76. 50.25(a)(4)§ 50.25 Elements of informed consent.
  77. 50.25(a)(5)§ 50.25 Elements of informed consent.
  78. 50.25(a)(6)§ 50.25 Elements of informed consent.
  79. 50.25(a)(7)§ 50.25 Elements of informed consent.
  80. 50.25(a)(8)§ 50.25 Elements of informed consent.
  81. 50.25(b)(1)§ 50.25 Elements of informed consent.
  82. 50.25(b)(2)§ 50.25 Elements of informed consent.
  83. 50.25(b)(3)§ 50.25 Elements of informed consent.
  84. 50.25(b)(4)§ 50.25 Elements of informed consent.
  85. 50.25(b)(5)§ 50.25 Elements of informed consent.
  86. 50.25(b)(6)§ 50.25 Elements of informed consent.
  87. 50.25(c)§ 50.25 Elements of informed consent.
  88. 50.27(a)§ 50.27 Documentation of informed consent.
  89. 50.27(b)(1)§ 50.27 Documentation of informed consent.
  90. 50.27(b)(2)§ 50.27 Documentation of informed consent.
  91. 50.51§ 50.51 Clinical investigations not involving greater than minimal risk.
  92. 50.52§ 50.52 Clinical investigations involving greater than minimal risk but presenting the…
  93. 50.53§ 50.53 Clinical investigations involving greater than minimal risk and no prospect of…
  94. 50.55(a)§ 50.55 Requirements for permission by parents or guardians and for assent by children.
  95. 50.55(b)§ 50.55 Requirements for permission by parents or guardians and for assent by children.
  96. 50.55(c)§ 50.55 Requirements for permission by parents or guardians and for assent by children.
  97. 50.55(e)(2)§ 50.55 Requirements for permission by parents or guardians and for assent by children.
  98. 50.55(f)§ 50.55 Requirements for permission by parents or guardians and for assent by children.
  99. 50.55(g)§ 50.55 Requirements for permission by parents or guardians and for assent by children.
  100. 50.56(b)§ 50.56 Wards.
  101. 507.105(a)(1)§ 507.105 Requirement to establish and implement a supply-chain program.
  102. 507.115(a)(1)§ 507.115 Responsibilities of the receiving facility.
  103. 507.115(a)(2)§ 507.115 Responsibilities of the receiving facility.
  104. 507.120(b)§ 507.120 Using approved suppliers.
  105. 507.135(b)§ 507.135 Onsite audit.
  106. 507.14§ 507.14 Personnel.
  107. 507.175(c)§ 507.175 Records documenting the supply-chain program.
  108. 507.17(a)§ 507.17 Plant and grounds.
  109. 507.17(b)§ 507.17 Plant and grounds.
  110. 507.17(c)§ 507.17 Plant and grounds.
  111. 507.19(a)§ 507.19 Sanitation.
  112. 507.19(b)§ 507.19 Sanitation.
  113. 507.19(c)§ 507.19 Sanitation.
  114. 507.19(d)(2)§ 507.19 Sanitation.
  115. 507.19(d)(3)§ 507.19 Sanitation.
  116. 507.19(e)§ 507.19 Sanitation.
  117. 507.19(f)§ 507.19 Sanitation.
  118. 507.20§ 507.20 Water supply and plumbing.
  119. 507.200(c)§ 507.200 Records subject to the requirements of this subpart.
  120. 507.202(a)§ 507.202 General requirements applying to records.
  121. 507.202(b)§ 507.202 General requirements applying to records.
  122. 507.22(a)(1)§ 507.22 Equipment and utensils.
  123. 507.22(a)(2)§ 507.22 Equipment and utensils.
  124. 507.22(a)(3)§ 507.22 Equipment and utensils.
  125. 507.22(a)(4)§ 507.22 Equipment and utensils.
  126. 507.22(b)§ 507.22 Equipment and utensils.
  127. 507.22(d)§ 507.22 Equipment and utensils.
  128. 507.25(a)§ 507.25 Plant operations.
  129. 507.25(a)(2)§ 507.25 Plant operations.
  130. 507.25(b)(1)§ 507.25 Plant operations.
  131. 507.25(b)(2)§ 507.25 Plant operations.
  132. 507.25(b)(3)§ 507.25 Plant operations.
  133. 507.25(c)(1)§ 507.25 Plant operations.
  134. 507.25(c)(2)§ 507.25 Plant operations.
  135. 507.25(c)(3)§ 507.25 Plant operations.
  136. 507.25(c)(4)§ 507.25 Plant operations.
  137. 507.25(c)(5)§ 507.25 Plant operations.
  138. 507.27(a)§ 507.27 Holding and distribution.
  139. 507.27(b)§ 507.27 Holding and distribution.
  140. 507.27(c)§ 507.27 Holding and distribution.
  141. 507.27(e)§ 507.27 Holding and distribution.
  142. 507.31(a)§ 507.31 Food safety plan.
  143. 507.31(b)§ 507.31 Food safety plan.
  144. 507.33(a)§ 507.33 Hazard analysis.
  145. 507.34(a)(1)§ 507.34 Preventive controls.
  146. 507.34(b)§ 507.34 Preventive controls.
  147. 507.34(c)(1)§ 507.34 Preventive controls.
  148. 507.34(c)(2)§ 507.34 Preventive controls.
  149. 507.34(c)(5)§ 507.34 Preventive controls.
  150. 507.36(a)§ 507.36 Circumstances in which the owner, operator, or agent in charge of a…
  151. 507.38(a)(1)§ 507.38 Recall plan.
  152. 507.38(b)§ 507.38 Recall plan.
  153. 507.4§ 507.4 Qualifications of individuals who manufacture, process, pack, or hold animal food.
  154. 507.40§ 507.40 Monitoring.
  155. 507.40(c)(1)§ 507.40 Monitoring.
  156. 507.42(a)(1)§ 507.42 Corrective actions and corrections.
  157. 507.42(a)(2)§ 507.42 Corrective actions and corrections.
  158. 507.42(b)(2)§ 507.42 Corrective actions and corrections.
  159. 507.42(d)§ 507.42 Corrective actions and corrections.
  160. 507.45(b)§ 507.45 Verification.
  161. 507.47(a)§ 507.47 Validation.
  162. 507.47(b)§ 507.47 Validation.
  163. 507.49(a)(1)§ 507.49 Verification of implementation and effectiveness.
  164. 507.49(a)(2)§ 507.49 Verification of implementation and effectiveness.
  165. 507.49(a)(3)§ 507.49 Verification of implementation and effectiveness.
  166. 507.49(a)(4)§ 507.49 Verification of implementation and effectiveness.
  167. 507.49(a)(5)§ 507.49 Verification of implementation and effectiveness.
  168. 507.49(b)(1)§ 507.49 Verification of implementation and effectiveness.
  169. 507.49(b)(2)§ 507.49 Verification of implementation and effectiveness.
  170. 507.49(b)(3)§ 507.49 Verification of implementation and effectiveness.
  171. 507.4(d)§ 507.4 Qualifications of individuals who manufacture, process, pack, or hold animal food.
  172. 507.50§ 507.50 Reanalysis.
  173. 507.50(d)§ 507.50 Reanalysis.
  174. 507.51(a)§ 507.51 Modified requirements that apply to a facility solely engaged in the storage of…
  175. 507.53(c)(1)§ 507.53 Requirements applicable to a preventive controls qualified individual and a…
  176. 507.7(a)(2)(i)§ 507.7 Requirements that apply to a qualified facility.
  177. 511.1(b)(4)§ 511.1 New animal drugs for investigational use exempt from section 512(a) of the Federal…
  178. 511.1(b)(7)(i)§ 511.1 New animal drugs for investigational use exempt from section 512(a) of the Federal…
  179. 511.1(b)(7)(ii)§ 511.1 New animal drugs for investigational use exempt from section 512(a) of the Federal…
  180. 511.1(b)(7)(iii)§ 511.1 New animal drugs for investigational use exempt from section 512(a) of the Federal…
  181. 511.1(b)(8)(ii)§ 511.1 New animal drugs for investigational use exempt from section 512(a) of the Federal…
  182. 511.1(b)(8)(iv)§ 511.1 New animal drugs for investigational use exempt from section 512(a) of the Federal…
  183. 514.80(a)(1)§ 514.80 Records and reports concerning experience with approved new animal drugs.
  184. 514.80(b)(1)§ 514.80 Records and reports concerning experience with approved new animal drugs.
  185. 514.80(b)(2)(i)§ 514.80 Records and reports concerning experience with approved new animal drugs.
  186. 514.80(b)(2)(ii)§ 514.80 Records and reports concerning experience with approved new animal drugs.
  187. 514.80(b)(4)§ 514.80 Records and reports concerning experience with approved new animal drugs.
  188. 514.80(b)(4)(iv)(B)§ 514.80 Records and reports concerning experience with approved new animal drugs.
  189. 530.11(a)§ 530.11 Limitations.
  190. 530.11(b)§ 530.11 Limitations.
  191. 530.11(d)§ 530.11 Limitations.
  192. 530.12(a)§ 530.12 Labeling.
  193. 530.12(b)§ 530.12 Labeling.
  194. 530.12(c)§ 530.12 Labeling.
  195. 530.12(d)§ 530.12 Labeling.
  196. 530.12(e)§ 530.12 Labeling.
  197. 530.13(a)§ 530.13 Extralabel use from compounding of approved new animal and approved human drugs.
  198. 530.13(b)(2)§ 530.13 Extralabel use from compounding of approved new animal and approved human drugs.
  199. 530.13(b)(3)§ 530.13 Extralabel use from compounding of approved new animal and approved human drugs.
  200. 530.13(b)(4)§ 530.13 Extralabel use from compounding of approved new animal and approved human drugs.
  201. 530.13(b)(5)§ 530.13 Extralabel use from compounding of approved new animal and approved human drugs.
  202. 530.20(a)(1)§ 530.20 Conditions for permitted extralabel animal and human drug use in food-producing…
  203. 530.20(a)(2)(i)§ 530.20 Conditions for permitted extralabel animal and human drug use in food-producing…
  204. 530.20(a)(2)(ii)§ 530.20 Conditions for permitted extralabel animal and human drug use in food-producing…
  205. 530.20(a)(2)(iii)§ 530.20 Conditions for permitted extralabel animal and human drug use in food-producing…
  206. 530.20(a)(2)(iv)§ 530.20 Conditions for permitted extralabel animal and human drug use in food-producing…
  207. 530.4§ 530.4 Advertising and promotion.
  208. 530.41(a)§ 530.41 Drugs prohibited for extralabel use in animals.
  209. 530.5(a)§ 530.5 Veterinary records.
  210. 530.5(b)§ 530.5 Veterinary records.
  211. 558.6(a)(1)§ 558.6 Veterinary feed directive drugs.
  212. 558.6(a)(2)§ 558.6 Veterinary feed directive drugs.
  213. 558.6(a)(3)§ 558.6 Veterinary feed directive drugs.
  214. 558.6(a)(6)§ 558.6 Veterinary feed directive drugs.
  215. 558.6(b)(1)§ 558.6 Veterinary feed directive drugs.
  216. 558.6(b)(2)§ 558.6 Veterinary feed directive drugs.
  217. 558.6(b)(3)§ 558.6 Veterinary feed directive drugs.
  218. 558.6(b)(3)(xv)§ 558.6 Veterinary feed directive drugs.
  219. 558.6(c)(1)§ 558.6 Veterinary feed directive drugs.
  220. 558.6(c)(2)§ 558.6 Veterinary feed directive drugs.
  221. 558.6(c)(4)§ 558.6 Veterinary feed directive drugs.
  222. 558.6(c)(5)§ 558.6 Veterinary feed directive drugs.
  223. 558.6(c)(8)§ 558.6 Veterinary feed directive drugs.
  224. 56.103(a)§ 56.103 Circumstances in which IRB review is required.
  225. 56.104(c)§ 56.104 Exemptions from IRB requirement.
  226. 56.106(a)§ 56.106 Registration.
  227. 56.106(b)(1)§ 56.106 Registration.
  228. 56.106(b)(2)§ 56.106 Registration.
  229. 56.106(b)(3)§ 56.106 Registration.
  230. 56.106(b)(4)§ 56.106 Registration.
  231. 56.106(c)§ 56.106 Registration.
  232. 56.106(e)§ 56.106 Registration.
  233. 56.107(a)§ 56.107 IRB membership.
  234. 56.107(c)§ 56.107 IRB membership.
  235. 56.107(d)§ 56.107 IRB membership.
  236. 56.107(e)§ 56.107 IRB membership.
  237. 56.107(f)§ 56.107 IRB membership.
  238. 56.108(a)(1)§ 56.108 IRB functions and operations.
  239. 56.108(a)(2)§ 56.108 IRB functions and operations.
  240. 56.108(a)(3)§ 56.108 IRB functions and operations.
  241. 56.108(a)(4)§ 56.108 IRB functions and operations.
  242. 56.108(b)(1)§ 56.108 IRB functions and operations.
  243. 56.108(b)(2)§ 56.108 IRB functions and operations.
  244. 56.108(b)(3)§ 56.108 IRB functions and operations.
  245. 56.108(c)§ 56.108 IRB functions and operations.
  246. 56.109(a)§ 56.109 IRB review of research.
  247. 56.109(b)§ 56.109 IRB review of research.
  248. 56.109(c)(1)§ 56.109 IRB review of research.
  249. 56.109(c)(2)§ 56.109 IRB review of research.
  250. 56.109(e)§ 56.109 IRB review of research.
  251. 56.109(f)§ 56.109 IRB review of research.
  252. 56.109(g)§ 56.109 IRB review of research.
  253. 56.109(h)§ 56.109 IRB review of research.
  254. 56.110(b)§ 56.110 Expedited review procedures for certain kinds of research involving no more than…
  255. 56.110(b)(1)§ 56.110 Expedited review procedures for certain kinds of research involving no more than…
  256. 56.110(b)(2)§ 56.110 Expedited review procedures for certain kinds of research involving no more than…
  257. 56.110(c)§ 56.110 Expedited review procedures for certain kinds of research involving no more than…
  258. 56.111(a)(1)§ 56.111 Criteria for IRB approval of research.
  259. 56.111(a)(3)§ 56.111 Criteria for IRB approval of research.
  260. 56.111(a)(4)§ 56.111 Criteria for IRB approval of research.
  261. 56.111(a)(5)§ 56.111 Criteria for IRB approval of research.
  262. 56.111(a)(6)§ 56.111 Criteria for IRB approval of research.
  263. 56.111(b)§ 56.111 Criteria for IRB approval of research.
  264. 56.111(c)§ 56.111 Criteria for IRB approval of research.
  265. 56.112§ 56.112 Review by institution.
  266. 56.113§ 56.113 Suspension or termination of IRB approval of research.
  267. 56.115(a)(1)§ 56.115 IRB records.
  268. 56.115(a)(2)§ 56.115 IRB records.
  269. 56.115(a)(3)§ 56.115 IRB records.
  270. 56.115(a)(4)§ 56.115 IRB records.
  271. 56.115(a)(5)§ 56.115 IRB records.
  272. 56.115(a)(6)§ 56.115 IRB records.
  273. 56.115(a)(7)§ 56.115 IRB records.
  274. 56.115(b)§ 56.115 IRB records.
  275. 58.10§ 58.10 Applicability to studies performed under grants and contracts.
  276. 58.105(a)§ 58.105 Test and control article characterization.
  277. 58.105(b)§ 58.105 Test and control article characterization.
  278. 58.105(c)§ 58.105 Test and control article characterization.
  279. 58.105(d)§ 58.105 Test and control article characterization.
  280. 58.107§ 58.107 Test and control article handling.
  281. 58.113(a)(1)§ 58.113 Mixtures of articles with carriers.
  282. 58.113(a)(2)§ 58.113 Mixtures of articles with carriers.
  283. 58.120(a)§ 58.120 Protocol.
  284. 58.120(a)(1)§ 58.120 Protocol.
  285. 58.120(a)(10)§ 58.120 Protocol.
  286. 58.120(a)(11)§ 58.120 Protocol.
  287. 58.120(a)(12)§ 58.120 Protocol.
  288. 58.120(a)(3)§ 58.120 Protocol.
  289. 58.120(a)(4)§ 58.120 Protocol.
  290. 58.120(a)(5)§ 58.120 Protocol.
  291. 58.120(a)(6)§ 58.120 Protocol.
  292. 58.120(a)(7)§ 58.120 Protocol.
  293. 58.120(a)(8)§ 58.120 Protocol.
  294. 58.120(a)(9)§ 58.120 Protocol.
  295. 58.120(b)§ 58.120 Protocol.
  296. 58.130(a)§ 58.130 Conduct of a nonclinical laboratory study.
  297. 58.130(b)§ 58.130 Conduct of a nonclinical laboratory study.
  298. 58.130(c)§ 58.130 Conduct of a nonclinical laboratory study.
  299. 58.130(d)§ 58.130 Conduct of a nonclinical laboratory study.
  300. 58.130(e)§ 58.130 Conduct of a nonclinical laboratory study.
  301. 58.185(a)§ 58.185 Reporting of nonclinical laboratory study results.
  302. 58.185(a)(1)§ 58.185 Reporting of nonclinical laboratory study results.
  303. 58.185(a)(10)§ 58.185 Reporting of nonclinical laboratory study results.
  304. 58.185(a)(11)§ 58.185 Reporting of nonclinical laboratory study results.
  305. 58.185(a)(12)§ 58.185 Reporting of nonclinical laboratory study results.
  306. 58.185(a)(13)§ 58.185 Reporting of nonclinical laboratory study results.
  307. 58.185(a)(14)§ 58.185 Reporting of nonclinical laboratory study results.
  308. 58.185(a)(2)§ 58.185 Reporting of nonclinical laboratory study results.
  309. 58.185(a)(3)§ 58.185 Reporting of nonclinical laboratory study results.
  310. 58.185(a)(4)§ 58.185 Reporting of nonclinical laboratory study results.
  311. 58.185(a)(5)§ 58.185 Reporting of nonclinical laboratory study results.
  312. 58.185(a)(6)§ 58.185 Reporting of nonclinical laboratory study results.
  313. 58.185(a)(7)§ 58.185 Reporting of nonclinical laboratory study results.
  314. 58.185(a)(8)§ 58.185 Reporting of nonclinical laboratory study results.
  315. 58.185(a)(9)§ 58.185 Reporting of nonclinical laboratory study results.
  316. 58.185(b)§ 58.185 Reporting of nonclinical laboratory study results.
  317. 58.185(c)§ 58.185 Reporting of nonclinical laboratory study results.
  318. 58.190(a)§ 58.190 Storage and retrieval of records and data.
  319. 58.190(b)§ 58.190 Storage and retrieval of records and data.
  320. 58.190(c)§ 58.190 Storage and retrieval of records and data.
  321. 58.190(d)§ 58.190 Storage and retrieval of records and data.
  322. 58.190(e)§ 58.190 Storage and retrieval of records and data.
  323. 58.195(b)§ 58.195 Retention of records.
  324. 58.195(d)§ 58.195 Retention of records.
  325. 58.195(e)§ 58.195 Retention of records.
  326. 58.195(g)§ 58.195 Retention of records.
  327. 58.195(h)§ 58.195 Retention of records.
  328. 58.29(a)§ 58.29 Personnel.
  329. 58.29(b)§ 58.29 Personnel.
  330. 58.29(c)§ 58.29 Personnel.
  331. 58.29(d)§ 58.29 Personnel.
  332. 58.29(e)§ 58.29 Personnel.
  333. 58.31(a)§ 58.31 Testing facility management.
  334. 58.31(b)§ 58.31 Testing facility management.
  335. 58.31(c)§ 58.31 Testing facility management.
  336. 58.31(d)§ 58.31 Testing facility management.
  337. 58.31(e)§ 58.31 Testing facility management.
  338. 58.31(f)§ 58.31 Testing facility management.
  339. 58.31(g)§ 58.31 Testing facility management.
  340. 58.33§ 58.33 Study director.
  341. 58.33(a)§ 58.33 Study director.
  342. 58.33(b)§ 58.33 Study director.
  343. 58.33(c)§ 58.33 Study director.
  344. 58.33(d)§ 58.33 Study director.
  345. 58.33(e)§ 58.33 Study director.
  346. 58.33(f)§ 58.33 Study director.
  347. 58.35(a)§ 58.35 Quality assurance unit.
  348. 58.35(b)(1)§ 58.35 Quality assurance unit.
  349. 58.35(b)(2)§ 58.35 Quality assurance unit.
  350. 58.35(b)(3)§ 58.35 Quality assurance unit.
  351. 58.35(b)(4)§ 58.35 Quality assurance unit.
  352. 58.35(b)(5)§ 58.35 Quality assurance unit.
  353. 58.35(b)(6)§ 58.35 Quality assurance unit.
  354. 58.35(b)(7)§ 58.35 Quality assurance unit.
  355. 58.35(c)§ 58.35 Quality assurance unit.
  356. 58.35(d)§ 58.35 Quality assurance unit.
  357. 58.41§ 58.41 General.
  358. 58.43(a)§ 58.43 Animal care facilities.
  359. 58.43(b)§ 58.43 Animal care facilities.
  360. 58.43(c)§ 58.43 Animal care facilities.
  361. 58.43(d)§ 58.43 Animal care facilities.
  362. 58.45§ 58.45 Animal supply facilities.
  363. 58.47(a)(1)§ 58.47 Facilities for handling test and control articles.
  364. 58.47(a)(2)§ 58.47 Facilities for handling test and control articles.
  365. 58.47(a)(3)§ 58.47 Facilities for handling test and control articles.
  366. 58.47(b)§ 58.47 Facilities for handling test and control articles.
  367. 58.49§ 58.49 Laboratory operation areas.
  368. 58.51§ 58.51 Specimen and data storage facilities.
  369. 58.61§ 58.61 Equipment design.
  370. 58.63(a)§ 58.63 Maintenance and calibration of equipment.
  371. 58.63(b)§ 58.63 Maintenance and calibration of equipment.
  372. 58.63(c)§ 58.63 Maintenance and calibration of equipment.
  373. 58.81(a)§ 58.81 Standard operating procedures.
  374. 58.81(b)§ 58.81 Standard operating procedures.
  375. 58.81(c)§ 58.81 Standard operating procedures.
  376. 58.81(d)§ 58.81 Standard operating procedures.
  377. 58.83§ 58.83 Reagents and solutions.
  378. 58.90(a)§ 58.90 Animal care.
  379. 58.90(b)§ 58.90 Animal care.
  380. 58.90(c)§ 58.90 Animal care.
  381. 58.90(d)§ 58.90 Animal care.
  382. 58.90(e)§ 58.90 Animal care.
  383. 58.90(f)§ 58.90 Animal care.
  384. 58.90(g)§ 58.90 Animal care.
  385. 58.90(h)§ 58.90 Animal care.
  386. 58.90(i)§ 58.90 Animal care.
  387. 589.2000(c)(1)(i)§ 589.2000 Animal proteins prohibited in ruminant feed.
  388. 589.2000(c)(1)(ii)§ 589.2000 Animal proteins prohibited in ruminant feed.
  389. 589.2000(d)(1)§ 589.2000 Animal proteins prohibited in ruminant feed.
  390. 589.2000(e)(1)§ 589.2000 Animal proteins prohibited in ruminant feed.
  391. 589.2000(f)§ 589.2000 Animal proteins prohibited in ruminant feed.
  392. 589.2001(c)(1)§ 589.2001 Cattle materials prohibited in animal food or feed to prevent the transmission…
  393. 589.2001(c)(2)(i)§ 589.2001 Cattle materials prohibited in animal food or feed to prevent the transmission…
  394. 589.2001(c)(2)(ii)§ 589.2001 Cattle materials prohibited in animal food or feed to prevent the transmission…
  395. 589.2001(c)(2)(iii)§ 589.2001 Cattle materials prohibited in animal food or feed to prevent the transmission…
  396. 589.2001(c)(2)(iv)§ 589.2001 Cattle materials prohibited in animal food or feed to prevent the transmission…
  397. 589.2001(c)(2)(v)§ 589.2001 Cattle materials prohibited in animal food or feed to prevent the transmission…
  398. 589.2001(c)(2)(vi)§ 589.2001 Cattle materials prohibited in animal food or feed to prevent the transmission…
  399. 589.2001(c)(3)(i)§ 589.2001 Cattle materials prohibited in animal food or feed to prevent the transmission…
  400. 589.2001(e)§ 589.2001 Cattle materials prohibited in animal food or feed to prevent the transmission…
  401. 600.10(b)§ 600.10 Personnel.
  402. 600.11(a)§ 600.11 Physical establishment, equipment, animals, and care.
  403. 600.11(b)§ 600.11 Physical establishment, equipment, animals, and care.
  404. 600.11(c)§ 600.11 Physical establishment, equipment, animals, and care.
  405. 600.11(e)(5)§ 600.11 Physical establishment, equipment, animals, and care.
  406. 600.11(h)§ 600.11 Physical establishment, equipment, animals, and care.
  407. 600.12(a)§ 600.12 Records.
  408. 600.12(b)(1)§ 600.12 Records.
  409. 600.12(b)(2)§ 600.12 Records.
  410. 600.12(c)§ 600.12 Records.
  411. 600.13§ 600.13 Retention samples.
  412. 600.14(a)(1)§ 600.14 Reporting of biological product deviations by licensed manufacturers.
  413. 600.14(c)§ 600.14 Reporting of biological product deviations by licensed manufacturers.
  414. 600.15§ 600.15 Temperatures during shipment.
  415. 600.80(b)§ 600.80 Postmarketing reporting of adverse experiences.
  416. 600.80(c)§ 600.80 Postmarketing reporting of adverse experiences.
  417. 600.80(c)(1)(i)§ 600.80 Postmarketing reporting of adverse experiences.
  418. 600.80(c)(1)(ii)§ 600.80 Postmarketing reporting of adverse experiences.
  419. 600.80(c)(1)(iii)§ 600.80 Postmarketing reporting of adverse experiences.
  420. 600.80(c)(2)(i)§ 600.80 Postmarketing reporting of adverse experiences.
  421. 600.80(c)(2)(ii)§ 600.80 Postmarketing reporting of adverse experiences.
  422. 600.81§ 600.81 Distribution reports.
  423. 601.12(b)§ 601.12 Changes to an approved application.
  424. 601.12(c)§ 601.12 Changes to an approved application.
  425. 601.12(d)§ 601.12 Changes to an approved application.
  426. 601.12(f)(1)§ 601.12 Changes to an approved application.
  427. 601.22§ 601.22 Products in short supply; initial manufacturing at other than licensed location.
  428. 606.100(a)§ 606.100 Standard operating procedures.
  429. 606.100(b)§ 606.100 Standard operating procedures.
  430. 606.100(b)(1)§ 606.100 Standard operating procedures.
  431. 606.100(b)(10)§ 606.100 Standard operating procedures.
  432. 606.100(b)(11)§ 606.100 Standard operating procedures.
  433. 606.100(b)(12)§ 606.100 Standard operating procedures.
  434. 606.100(b)(13)§ 606.100 Standard operating procedures.
  435. 606.100(b)(14)§ 606.100 Standard operating procedures.
  436. 606.100(b)(15)§ 606.100 Standard operating procedures.
  437. 606.100(b)(16)§ 606.100 Standard operating procedures.
  438. 606.100(b)(17)§ 606.100 Standard operating procedures.
  439. 606.100(b)(18)§ 606.100 Standard operating procedures.
  440. 606.100(b)(19)§ 606.100 Standard operating procedures.
  441. 606.100(b)(2)§ 606.100 Standard operating procedures.
  442. 606.100(b)(20)§ 606.100 Standard operating procedures.
  443. 606.100(b)(21)§ 606.100 Standard operating procedures.
  444. 606.100(b)(22)§ 606.100 Standard operating procedures.
  445. 606.100(b)(3)§ 606.100 Standard operating procedures.
  446. 606.100(b)(4)§ 606.100 Standard operating procedures.
  447. 606.100(b)(5)§ 606.100 Standard operating procedures.
  448. 606.100(b)(6)§ 606.100 Standard operating procedures.
  449. 606.100(b)(7)§ 606.100 Standard operating procedures.
  450. 606.100(b)(8)§ 606.100 Standard operating procedures.
  451. 606.100(b)(9)§ 606.100 Standard operating procedures.
  452. 606.100(c)§ 606.100 Standard operating procedures.
  453. 606.110(a)§ 606.110 Plateletpheresis, leukapheresis, and plasmapheresis.
  454. 606.110(b)§ 606.110 Plateletpheresis, leukapheresis, and plasmapheresis.
  455. 606.120(a)§ 606.120 Labeling, general requirements.
  456. 606.120(b)(1)§ 606.120 Labeling, general requirements.
  457. 606.120(b)(2)§ 606.120 Labeling, general requirements.
  458. 606.120(b)(3)§ 606.120 Labeling, general requirements.
  459. 606.120(c)§ 606.120 Labeling, general requirements.
  460. 606.121(b)§ 606.121 Container label.
  461. 606.121(c)(1)§ 606.121 Container label.
  462. 606.121(c)(10)§ 606.121 Container label.
  463. 606.121(c)(11)§ 606.121 Container label.
  464. 606.121(c)(12)§ 606.121 Container label.
  465. 606.121(c)(13)§ 606.121 Container label.
  466. 606.121(c)(2)§ 606.121 Container label.
  467. 606.121(c)(3)§ 606.121 Container label.
  468. 606.121(c)(4)(i)§ 606.121 Container label.
  469. 606.121(c)(4)(ii)§ 606.121 Container label.
  470. 606.121(c)(5)§ 606.121 Container label.
  471. 606.121(c)(6)§ 606.121 Container label.
  472. 606.121(c)(7)§ 606.121 Container label.
  473. 606.121(c)(8)§ 606.121 Container label.
  474. 606.121(c)(9)§ 606.121 Container label.
  475. 606.121(d)§ 606.121 Container label.
  476. 606.121(e)§ 606.121 Container label.
  477. 606.121(e)(5)§ 606.121 Container label.
  478. 606.121(f)§ 606.121 Container label.
  479. 606.121(h)§ 606.121 Container label.
  480. 606.121(i)§ 606.121 Container label.
  481. 606.121(i)(5)§ 606.121 Container label.
  482. 606.122§ 606.122 Circular of information.
  483. 606.140(a)§ 606.140 Laboratory controls.
  484. 606.140(b)§ 606.140 Laboratory controls.
  485. 606.140(c)§ 606.140 Laboratory controls.
  486. 606.145(a)§ 606.145 Control of bacterial contamination of platelets.
  487. 606.145(b)§ 606.145 Control of bacterial contamination of platelets.
  488. 606.145(c)§ 606.145 Control of bacterial contamination of platelets.
  489. 606.145(d)§ 606.145 Control of bacterial contamination of platelets.
  490. 606.151(a)§ 606.151 Compatibility testing.
  491. 606.151(b)§ 606.151 Compatibility testing.
  492. 606.151(d)§ 606.151 Compatibility testing.
  493. 606.151(e)§ 606.151 Compatibility testing.
  494. 606.160(a)(1)§ 606.160 Records.
  495. 606.160(a)(2)§ 606.160 Records.
  496. 606.160(b)§ 606.160 Records.
  497. 606.160(b)(6)§ 606.160 Records.
  498. 606.160(c)§ 606.160 Records.
  499. 606.160(d)§ 606.160 Records.
  500. 606.160(e)(1)§ 606.160 Records.
  501. 606.160(e)(2)§ 606.160 Records.
  502. 606.165(a)§ 606.165 Distribution and receipt; procedures and records.
  503. 606.165(b)§ 606.165 Distribution and receipt; procedures and records.
  504. 606.165(c)§ 606.165 Distribution and receipt; procedures and records.
  505. 606.170(a)§ 606.170 Adverse reaction file.
  506. 606.170(b)§ 606.170 Adverse reaction file.
  507. 606.171§ 606.171 Reporting of product deviations by licensed manufacturers, unlicensed registered…
  508. 606.171(a)§ 606.171 Reporting of product deviations by licensed manufacturers, unlicensed registered…
  509. 606.20(b)§ 606.20 Personnel.
  510. 606.20(c)§ 606.20 Personnel.
  511. 606.40§ 606.40 Facilities.
  512. 606.40(a)(1)§ 606.40 Facilities.
  513. 606.40(a)(2)§ 606.40 Facilities.
  514. 606.40(a)(3)§ 606.40 Facilities.
  515. 606.40(a)(5)§ 606.40 Facilities.
  516. 606.40(a)(6)§ 606.40 Facilities.
  517. 606.40(a)(7)§ 606.40 Facilities.
  518. 606.40(a)(8)§ 606.40 Facilities.
  519. 606.40(a)(9)§ 606.40 Facilities.
  520. 606.40(b)§ 606.40 Facilities.
  521. 606.40(c)§ 606.40 Facilities.
  522. 606.40(d)(1)§ 606.40 Facilities.
  523. 606.40(d)(2)§ 606.40 Facilities.
  524. 606.60(a)§ 606.60 Equipment.
  525. 606.60(b)§ 606.60 Equipment.
  526. 606.60(c)§ 606.60 Equipment.
  527. 606.65§ 606.65 Supplies and reagents.
  528. 606.65(a)§ 606.65 Supplies and reagents.
  529. 606.65(b)§ 606.65 Supplies and reagents.
  530. 606.65(c)§ 606.65 Supplies and reagents.
  531. 606.65(d)§ 606.65 Supplies and reagents.
  532. 606.65(e)§ 606.65 Supplies and reagents.
  533. 610.1§ 610.1 Tests prior to release required for each lot.
  534. 610.10§ 610.10 Potency.
  535. 610.11
  536. 610.12§ 610.12 Sterility.
  537. 610.12(d)§ 610.12 Sterility.
  538. 610.18(b)§ 610.18 Cultures.
  539. 610.40(a)§ 610.40 Test requirements.
  540. 610.40(a)(2)§ 610.40 Test requirements.
  541. 610.40(b)§ 610.40 Test requirements.
  542. 610.40(c)(2)§ 610.40 Test requirements.
  543. 610.40(d)(2)§ 610.40 Test requirements.
  544. 610.40(d)(4)§ 610.40 Test requirements.
  545. 610.40(e)§ 610.40 Test requirements.
  546. 610.40(f)§ 610.40 Test requirements.
  547. 610.40(g)§ 610.40 Test requirements.
  548. 610.40(h)§ 610.40 Test requirements.
  549. 610.40(h)(2)(ii)§ 610.40 Test requirements.
  550. 610.41§ 610.41 Donor deferral.
  551. 610.46(a)§ 610.46 Human immunodeficiency virus (HIV) “lookback” requirements.
  552. 610.46(a)(1)§ 610.46 Human immunodeficiency virus (HIV) “lookback” requirements.
  553. 610.46(a)(1)(B)
  554. 610.46(a)(2)§ 610.46 Human immunodeficiency virus (HIV) “lookback” requirements.
  555. 610.46(a)(3)§ 610.46 Human immunodeficiency virus (HIV) “lookback” requirements.
  556. 610.46(b)§ 610.46 Human immunodeficiency virus (HIV) “lookback” requirements.
  557. 610.46(b)(3)§ 610.46 Human immunodeficiency virus (HIV) “lookback” requirements.
  558. 610.47§ 610.47 Hepatitis C virus (HCV) “lookback” requirements.
  559. 610.47(a)§ 610.47 Hepatitis C virus (HCV) “lookback” requirements.
  560. 610.47(a)(1)§ 610.47 Hepatitis C virus (HCV) “lookback” requirements.
  561. 610.47(a)(3)§ 610.47 Hepatitis C virus (HCV) “lookback” requirements.
  562. 610.47(b)§ 610.47 Hepatitis C virus (HCV) “lookback” requirements.
  563. 610.47(b)(3)§ 610.47 Hepatitis C virus (HCV) “lookback” requirements.
  564. 610.53(b)§ 610.53 Dating periods for Whole Blood and blood components.
  565. 610.60§ 610.60 Container label.
  566. 610.60(a)§ 610.60 Container label.
  567. 610.61§ 610.61 Package label.
  568. 610.63§ 610.63 Divided manufacturing responsibility to be shown.
  569. 630.10(a)§ 630.10 General donor eligibility requirements.
  570. 630.10(b)§ 630.10 General donor eligibility requirements.
  571. 630.10(c)§ 630.10 General donor eligibility requirements.
  572. 630.10(d)(2)§ 630.10 General donor eligibility requirements.
  573. 630.10(d)(4)§ 630.10 General donor eligibility requirements.
  574. 630.10(e)§ 630.10 General donor eligibility requirements.
  575. 630.10(e)(1)§ 630.10 General donor eligibility requirements.
  576. 630.10(e)(2)§ 630.10 General donor eligibility requirements.
  577. 630.10(f)(3)§ 630.10 General donor eligibility requirements.
  578. 630.10(f)(3)(i)(B)§ 630.10 General donor eligibility requirements.
  579. 630.10(f)(4)§ 630.10 General donor eligibility requirements.
  580. 630.10(f)(6)(i)§ 630.10 General donor eligibility requirements.
  581. 630.10(f)(6)(ii)§ 630.10 General donor eligibility requirements.
  582. 630.10(g)(1)§ 630.10 General donor eligibility requirements.
  583. 630.10(g)(2)§ 630.10 General donor eligibility requirements.
  584. 630.10(g)(2)(ii)§ 630.10 General donor eligibility requirements.
  585. 630.10(h)§ 630.10 General donor eligibility requirements.
  586. 630.15(b)(1)§ 630.15 Donor eligibility requirements specific to Whole Blood, Red Blood Cells and…
  587. 630.15(b)(1)(ii)§ 630.15 Donor eligibility requirements specific to Whole Blood, Red Blood Cells and…
  588. 630.15(b)(2)§ 630.15 Donor eligibility requirements specific to Whole Blood, Red Blood Cells and…
  589. 630.15(b)(2)(iii)§ 630.15 Donor eligibility requirements specific to Whole Blood, Red Blood Cells and…
  590. 630.15(b)(3)§ 630.15 Donor eligibility requirements specific to Whole Blood, Red Blood Cells and…
  591. 630.15(b)(6)§ 630.15 Donor eligibility requirements specific to Whole Blood, Red Blood Cells and…
  592. 630.30(a)§ 630.30 Donation suitability requirements.
  593. 630.30(a)(1)§ 630.30 Donation suitability requirements.
  594. 630.30(a)(2)§ 630.30 Donation suitability requirements.
  595. 630.30(a)(3)§ 630.30 Donation suitability requirements.
  596. 630.30(b)(1)§ 630.30 Donation suitability requirements.
  597. 630.30(b)(2)§ 630.30 Donation suitability requirements.
  598. 630.40(a)§ 630.40 Requirements for notifying deferred donors.
  599. 630.40(b)(1)§ 630.40 Requirements for notifying deferred donors.
  600. 630.40(b)(2)§ 630.40 Requirements for notifying deferred donors.
  601. 630.40(b)(3)§ 630.40 Requirements for notifying deferred donors.
  602. 630.40(b)(4)§ 630.40 Requirements for notifying deferred donors.
  603. 630.40(c)§ 630.40 Requirements for notifying deferred donors.
  604. 630.40(d)(1)§ 630.40 Requirements for notifying deferred donors.
  605. 630.40(d)(2)§ 630.40 Requirements for notifying deferred donors.
  606. 630.5(b)§ 630.5 Medical supervision.
  607. 630.5(b)(2)§ 630.5 Medical supervision.
  608. 630.5(c)(1)§ 630.5 Medical supervision.
  609. 630.5(c)(1)(i)§ 630.5 Medical supervision.
  610. 630.5(d)§ 630.5 Medical supervision.
  611. 640.11(a)§ 640.11 General requirements.
  612. 640.11(b)§ 640.11 General requirements.
  613. 640.120§ 640.120 Alternative procedures.
  614. 640.120(a)§ 640.120 Alternative procedures.
  615. 640.15(a)§ 640.15 Segments for testing.
  616. 640.16(a)§ 640.16 Processing.
  617. 640.16(b)§ 640.16 Processing.
  618. 640.17§ 640.17 Modifications for specific products.
  619. 640.21(a)§ 640.21 Eligibility of donors.
  620. 640.21(e)§ 640.21 Eligibility of donors.
  621. 640.21(f)§ 640.21 Eligibility of donors.
  622. 640.21(g)§ 640.21 Eligibility of donors.
  623. 640.24(a)§ 640.24 Processing.
  624. 640.24(b)§ 640.24 Processing.
  625. 640.25(a)§ 640.25 General requirements.
  626. 640.25(b)§ 640.25 General requirements.
  627. 640.25(b)(4)§ 640.25 General requirements.
  628. 640.2(c)(3)§ 640.2 General requirements.
  629. 640.31§ 640.31 Eligibility of donors.
  630. 640.31(a)§ 640.31 Eligibility of donors.
  631. 640.31(b)§ 640.31 Eligibility of donors.
  632. 640.32(a)§ 640.32 Collection of source material.
  633. 640.34(b)§ 640.34 Processing.
  634. 640.34(c)§ 640.34 Processing.
  635. 640.34(g)(1)§ 640.34 Processing.
  636. 640.34(g)(2)§ 640.34 Processing.
  637. 640.3(a)
  638. 640.3(a)(1)
  639. 640.3(b)(1)
  640. 640.3(b)(2)
  641. 640.3(b)(3)
  642. 640.3(b)(5)
  643. 640.3(b)(6)
  644. 640.3(c)(1)
  645. 640.3(c)(2)
  646. 640.3(d)
  647. 640.3(f)
  648. 640.4(c)§ 640.4 Collection of the blood.
  649. 640.4(e)§ 640.4 Collection of the blood.
  650. 640.4(f)§ 640.4 Collection of the blood.
  651. 640.4(g)(2)§ 640.4 Collection of the blood.
  652. 640.4(g)(3)§ 640.4 Collection of the blood.
  653. 640.4(g)(5)§ 640.4 Collection of the blood.
  654. 640.4(h)§ 640.4 Collection of the blood.
  655. 640.5§ 640.5 Testing the blood.
  656. 640.52§ 640.52 Collection of source material.
  657. 640.53(b)§ 640.53 Testing the blood.
  658. 640.56(d)§ 640.56 Quality control test for potency.
  659. 640.5(b)§ 640.5 Testing the blood.
  660. 640.5(c)§ 640.5 Testing the blood.
  661. 640.5(e)§ 640.5 Testing the blood.
  662. 640.61
  663. 640.62
  664. 640.63(a)
  665. 640.63(b)(1)
  666. 640.63(b)(3)
  667. 640.63(c)(1)
  668. 640.63(c)(10)
  669. 640.63(c)(11)
  670. 640.63(c)(2)
  671. 640.63(c)(3)
  672. 640.63(c)(4)
  673. 640.63(c)(5)
  674. 640.63(c)(6)
  675. 640.63(c)(8)
  676. 640.63(c)(9)
  677. 640.63(d)
  678. 640.63(e)
  679. 640.64(a)§ 640.64 Collection of blood for Source Plasma.
  680. 640.64(d)§ 640.64 Collection of blood for Source Plasma.
  681. 640.64(e)§ 640.64 Collection of blood for Source Plasma.
  682. 640.65(b)(1)(i)§ 640.65 Plasmapheresis.
  683. 640.65(b)(1)(iii)§ 640.65 Plasmapheresis.
  684. 640.65(b)(2)(i)§ 640.65 Plasmapheresis.
  685. 640.65(b)(3)§ 640.65 Plasmapheresis.
  686. 640.65(b)(4)§ 640.65 Plasmapheresis.
  687. 640.65(b)(8)§ 640.65 Plasmapheresis.
  688. 640.66§ 640.66 Immunization of donors.
  689. 640.67§ 640.67 Laboratory tests.
  690. 640.68(a)§ 640.68 Processing.
  691. 640.68(b)§ 640.68 Processing.
  692. 640.69(b)§ 640.69 General requirements.
  693. 640.71(b)§ 640.71 Manufacturing responsibility.
  694. 640.72(a)(1)§ 640.72 Records.
  695. 640.72(a)(2)§ 640.72 Records.
  696. 640.72(a)(3)§ 640.72 Records.
  697. 640.72(a)(4)§ 640.72 Records.
  698. 640.72(b)§ 640.72 Records.
  699. 640.72(c)§ 640.72 Records.
  700. 640.72(d)§ 640.72 Records.
  701. 640.73§ 640.73 Reporting of fatal donor reactions.
  702. 640.76(a)§ 640.76 Products stored or shipped at unacceptable temperatures.
  703. 640.76(a)(2)§ 640.76 Products stored or shipped at unacceptable temperatures.
  704. 640.76(c)§ 640.76 Products stored or shipped at unacceptable temperatures.
  705. 640.81(c)§ 640.81 Processing.
  706. 660.31§ 660.31 Eligibility of donor.
  707. 660.32§ 660.32 Collection of source material.
  708. 660.33§ 660.33 Testing of source material.
  709. 660.52§ 660.52 Reference preparations.
  710. 680.1(b)(2)(iii)§ 680.1 Allergenic Products.
  711. 700.25(c)§ 700.25 Tamper-resistant packaging requirements for cosmetic products.
  712. 70.20§ 70.20 Packaging requirements for straight colors (other than hair dyes).
  713. 70.25§ 70.25 Labeling requirements for color additives (other than hair dyes).
  714. 74.101(e)§ 74.101 FD&C Blue No. 1.
  715. 74.705(e)§ 74.705 FD&C Yellow No. 5.
  716. 801.20(a)§ 801.20 Label to bear a unique device identifier.
  717. 801.40(a)§ 801.40 Form of a unique device identifier.
  718. 801.45(a)§ 801.45 Devices that must be directly marked with a unique device identifier.
  719. 801.50(a)§ 801.50 Labeling requirements for stand-alone software.
  720. 803.11§ 803.11 What form should I use to submit reports of individual adverse events and where…
  721. 803.12(b)§ 803.12 How do I submit initial and supplemental or followup reports?
  722. 803.17§ 803.17 What are the requirements for developing, maintaining, and implementing written…
  723. 803.17(a)(1)§ 803.17 What are the requirements for developing, maintaining, and implementing written…
  724. 803.17(a)(2)§ 803.17 What are the requirements for developing, maintaining, and implementing written…
  725. 803.17(a)(3)§ 803.17 What are the requirements for developing, maintaining, and implementing written…
  726. 803.17(b)§ 803.17 What are the requirements for developing, maintaining, and implementing written…
  727. 803.17(b)(1)§ 803.17 What are the requirements for developing, maintaining, and implementing written…
  728. 803.17(b)(2)§ 803.17 What are the requirements for developing, maintaining, and implementing written…
  729. 803.17(b)(4)§ 803.17 What are the requirements for developing, maintaining, and implementing written…
  730. 803.18(a)§ 803.18 What are the requirements for establishing and maintaining MDR files or records…
  731. 803.18(b)(1)(i)§ 803.18 What are the requirements for establishing and maintaining MDR files or records…
  732. 803.18(b)(1)(ii)§ 803.18 What are the requirements for establishing and maintaining MDR files or records…
  733. 803.18(b)(1)(iii)§ 803.18 What are the requirements for establishing and maintaining MDR files or records…
  734. 803.18(b)(2)§ 803.18 What are the requirements for establishing and maintaining MDR files or records…
  735. 803.18(d)(1)§ 803.18 What are the requirements for establishing and maintaining MDR files or records…
  736. 803.18(d)(2)§ 803.18 What are the requirements for establishing and maintaining MDR files or records…
  737. 803.18(d)(3)§ 803.18 What are the requirements for establishing and maintaining MDR files or records…
  738. 803.18(e)§ 803.18 What are the requirements for establishing and maintaining MDR files or records…
  739. 803.20(a)(1)§ 803.20 How do I complete and submit an individual adverse event report?
  740. 803.20(a)(2)§ 803.20 How do I complete and submit an individual adverse event report?
  741. 803.30(a)(1)§ 803.30 If I am a user facility, what reporting requirements apply to me?
  742. 803.30(a)(2)§ 803.30 If I am a user facility, what reporting requirements apply to me?
  743. 803.32§ 803.32 If I am a user facility, what information must I submit in my individual adverse…
  744. 803.33(a)§ 803.33 If I am a user facility, what must I include when I submit an annual report?
  745. 803.40(a)§ 803.40 If I am an importer, what reporting requirements apply to me?
  746. 803.40(b)§ 803.40 If I am an importer, what reporting requirements apply to me?
  747. 803.42(e)(1)§ 803.42 If I am an importer, what information must I submit in my individual adverse…
  748. 803.50(a)(1)§ 803.50 If I am a manufacturer, what reporting requirements apply to me?
  749. 803.50(a)(2)§ 803.50 If I am a manufacturer, what reporting requirements apply to me?
  750. 803.50(b)(1)§ 803.50 If I am a manufacturer, what reporting requirements apply to me?
  751. 803.50(b)(2)§ 803.50 If I am a manufacturer, what reporting requirements apply to me?
  752. 803.50(b)(3)§ 803.50 If I am a manufacturer, what reporting requirements apply to me?
  753. 803.52(a)(1)§ 803.52 If I am a manufacturer, what information must I submit in my individual adverse…
  754. 803.52(a)(2)§ 803.52 If I am a manufacturer, what information must I submit in my individual adverse…
  755. 803.52(a)(3)§ 803.52 If I am a manufacturer, what information must I submit in my individual adverse…
  756. 803.52(a)(4)§ 803.52 If I am a manufacturer, what information must I submit in my individual adverse…
  757. 803.52(b)(1)§ 803.52 If I am a manufacturer, what information must I submit in my individual adverse…
  758. 803.52(b)(2)§ 803.52 If I am a manufacturer, what information must I submit in my individual adverse…
  759. 803.52(b)(2)(i)§ 803.52 If I am a manufacturer, what information must I submit in my individual adverse…
  760. 803.52(b)(2)(iii)§ 803.52 If I am a manufacturer, what information must I submit in my individual adverse…
  761. 803.52(b)(3)§ 803.52 If I am a manufacturer, what information must I submit in my individual adverse…
  762. 803.52(b)(4)§ 803.52 If I am a manufacturer, what information must I submit in my individual adverse…
  763. 803.52(b)(5)§ 803.52 If I am a manufacturer, what information must I submit in my individual adverse…
  764. 803.52(c)(1)§ 803.52 If I am a manufacturer, what information must I submit in my individual adverse…
  765. 803.52(c)(10)§ 803.52 If I am a manufacturer, what information must I submit in my individual adverse…
  766. 803.52(c)(3)§ 803.52 If I am a manufacturer, what information must I submit in my individual adverse…
  767. 803.52(c)(4)§ 803.52 If I am a manufacturer, what information must I submit in my individual adverse…
  768. 803.52(e)(1)§ 803.52 If I am a manufacturer, what information must I submit in my individual adverse…
  769. 803.52(e)(4)§ 803.52 If I am a manufacturer, what information must I submit in my individual adverse…
  770. 803.52(e)(5)§ 803.52 If I am a manufacturer, what information must I submit in my individual adverse…
  771. 803.52(f)(1)§ 803.52 If I am a manufacturer, what information must I submit in my individual adverse…
  772. 803.52(f)(11)(iii)§ 803.52 If I am a manufacturer, what information must I submit in my individual adverse…
  773. 803.52(f)(3)§ 803.52 If I am a manufacturer, what information must I submit in my individual adverse…
  774. 803.52(f)(4)§ 803.52 If I am a manufacturer, what information must I submit in my individual adverse…
  775. 803.52(f)(6)§ 803.52 If I am a manufacturer, what information must I submit in my individual adverse…
  776. 803.52(f)(7)§ 803.52 If I am a manufacturer, what information must I submit in my individual adverse…
  777. 803.52(f)(8)§ 803.52 If I am a manufacturer, what information must I submit in my individual adverse…
  778. 803.52(f)(9)§ 803.52 If I am a manufacturer, what information must I submit in my individual adverse…
  779. 803.53(a)§ 803.53 If I am a manufacturer, in which circumstances must I submit a 5-day report?
  780. 803.55(a)
  781. 803.55(b)
  782. 803.55(b)(6)
  783. 803.55(b)(9)
  784. 803.56§ 803.56 If I am a manufacturer, in what circumstances must I submit a supplemental or…
  785. 80.37§ 80.37 Treatment of batch pending certification.
  786. 80.38(a)§ 80.38 Treatment of batch after certification.
  787. 806.10(a)(1)§ 806.10 Reports of corrections and removals.
  788. 806.10(a)(2)§ 806.10 Reports of corrections and removals.
  789. 806.10(b)§ 806.10 Reports of corrections and removals.
  790. 806.10(c)(1)§ 806.10 Reports of corrections and removals.
  791. 806.10(c)(10)§ 806.10 Reports of corrections and removals.
  792. 806.10(c)(11)§ 806.10 Reports of corrections and removals.
  793. 806.10(c)(13)§ 806.10 Reports of corrections and removals.
  794. 806.10(c)(4)§ 806.10 Reports of corrections and removals.
  795. 806.10(c)(7)§ 806.10 Reports of corrections and removals.
  796. 806.10(c)(8)§ 806.10 Reports of corrections and removals.
  797. 806.10(c)(9)§ 806.10 Reports of corrections and removals.
  798. 806.10(d)§ 806.10 Reports of corrections and removals.
  799. 806.20(a)§ 806.20 Records of corrections and removals not required to be reported.
  800. 806.20(b)(1)§ 806.20 Records of corrections and removals not required to be reported.
  801. 806.20(b)(2)§ 806.20 Records of corrections and removals not required to be reported.
  802. 806.20(b)(3)§ 806.20 Records of corrections and removals not required to be reported.
  803. 806.20(b)(4)§ 806.20 Records of corrections and removals not required to be reported.
  804. 806.20(b)(5)§ 806.20 Records of corrections and removals not required to be reported.
  805. 806.20(c)§ 806.20 Records of corrections and removals not required to be reported.
  806. 806.30§ 806.30 FDA access to records.
  807. 807.20§ 807.20 Who must register and submit a device list?
  808. 807.20(a)§ 807.20 Who must register and submit a device list?
  809. 807.21(a)§ 807.21 How to register establishments and list devices.
  810. 807.21(b)§ 807.21 How to register establishments and list devices.
  811. 807.22(a)§ 807.22 Times for establishment registration and device listing.
  812. 807.22(b)(1)§ 807.22 Times for establishment registration and device listing.
  813. 807.22(b)(3)§ 807.22 Times for establishment registration and device listing.
  814. 807.25(g)§ 807.25 Information required for device establishment registration and device listing.
  815. 807.28(a)§ 807.28 Updating device listing information.
  816. 807.40(a)§ 807.40 Establishment registration and device listing for foreign establishments…
  817. 809.10(a)(2)§ 809.10 Labeling for in vitro diagnostic products.
  818. 809.10(a)(5)§ 809.10 Labeling for in vitro diagnostic products.
  819. 809.10(a)(6)§ 809.10 Labeling for in vitro diagnostic products.
  820. 809.10(a)(8)§ 809.10 Labeling for in vitro diagnostic products.
  821. 809.10(a)(9)§ 809.10 Labeling for in vitro diagnostic products.
  822. 809.10(a)(9)(i)§ 809.10 Labeling for in vitro diagnostic products.
  823. 809.10(b)(10)§ 809.10 Labeling for in vitro diagnostic products.
  824. 809.10(b)(5)(iv)§ 809.10 Labeling for in vitro diagnostic products.
  825. 809.10(c)(2)(ii)§ 809.10 Labeling for in vitro diagnostic products.
  826. 809.20(b)§ 809.20 General requirements for manufacturers and producers of in vitro diagnostic…
  827. 812.100§ 812.100 General responsibilities of investigators.
  828. 812.110(a)§ 812.110 Specific responsibilities of investigators.
  829. 812.110(b)§ 812.110 Specific responsibilities of investigators.
  830. 812.110(c)§ 812.110 Specific responsibilities of investigators.
  831. 812.110(d)§ 812.110 Specific responsibilities of investigators.
  832. 812.110(e)§ 812.110 Specific responsibilities of investigators.
  833. 812.140(a)(1)§ 812.140 Records.
  834. 812.140(a)(2)(i)§ 812.140 Records.
  835. 812.140(a)(2)(ii)§ 812.140 Records.
  836. 812.140(a)(2)(iii)§ 812.140 Records.
  837. 812.140(a)(3)§ 812.140 Records.
  838. 812.140(a)(3)(i)§ 812.140 Records.
  839. 812.140(a)(3)(ii)§ 812.140 Records.
  840. 812.140(a)(3)(iii)§ 812.140 Records.
  841. 812.140(a)(4)§ 812.140 Records.
  842. 812.140(a)(5)§ 812.140 Records.
  843. 812.140(b)(1)§ 812.140 Records.
  844. 812.140(b)(2)§ 812.140 Records.
  845. 812.140(b)(3)§ 812.140 Records.
  846. 812.140(b)(4)§ 812.140 Records.
  847. 812.140(b)(4)(i)§ 812.140 Records.
  848. 812.140(b)(4)(ii)§ 812.140 Records.
  849. 812.140(b)(4)(iii)§ 812.140 Records.
  850. 812.140(b)(4)(iv)§ 812.140 Records.
  851. 812.140(b)(4)(v)§ 812.140 Records.
  852. 812.140(b)(4)(vi)§ 812.140 Records.
  853. 812.140(b)(5)§ 812.140 Records.
  854. 812.140(b)(6)§ 812.140 Records.
  855. 812.140(d)§ 812.140 Records.
  856. 812.140(e)§ 812.140 Records.
  857. 812.145(b)§ 812.145 Inspections.
  858. 812.150(a)(1)§ 812.150 Reports.
  859. 812.150(a)(2)§ 812.150 Reports.
  860. 812.150(a)(3)§ 812.150 Reports.
  861. 812.150(a)(4)§ 812.150 Reports.
  862. 812.150(a)(5)§ 812.150 Reports.
  863. 812.150(a)(6)§ 812.150 Reports.
  864. 812.150(a)(7)§ 812.150 Reports.
  865. 812.150(b)(1)§ 812.150 Reports.
  866. 812.150(b)(10)§ 812.150 Reports.
  867. 812.150(b)(2)§ 812.150 Reports.
  868. 812.150(b)(3)§ 812.150 Reports.
  869. 812.150(b)(4)§ 812.150 Reports.
  870. 812.150(b)(5)§ 812.150 Reports.
  871. 812.150(b)(6)§ 812.150 Reports.
  872. 812.150(b)(7)§ 812.150 Reports.
  873. 812.150(b)(8)§ 812.150 Reports.
  874. 812.18(b)§ 812.18 Import and export requirements.
  875. 812.20(a)(1)§ 812.20 Application.
  876. 812.20(a)(2)§ 812.20 Application.
  877. 812.25(e)§ 812.25 Investigational plan.
  878. 812.2(b)§ 812.2 Applicability.
  879. 812.2(c)§ 812.2 Applicability.
  880. 812.2(c)(3)§ 812.2 Applicability.
  881. 812.2(c)(7)§ 812.2 Applicability.
  882. 812.35(a)(1)§ 812.35 Supplemental applications.
  883. 812.35(a)(3)(iv)§ 812.35 Supplemental applications.
  884. 812.36(d)§ 812.36 Treatment use of an investigational device.
  885. 812.36(e)§ 812.36 Treatment use of an investigational device.
  886. 812.40§ 812.40 General responsibilities of sponsors.
  887. 812.42§ 812.42 FDA and IRB approval.
  888. 812.43(a)§ 812.43 Selecting investigators and monitors.
  889. 812.43(b)§ 812.43 Selecting investigators and monitors.
  890. 812.43(c)§ 812.43 Selecting investigators and monitors.
  891. 812.43(c)(1)§ 812.43 Selecting investigators and monitors.
  892. 812.43(c)(2)§ 812.43 Selecting investigators and monitors.
  893. 812.43(c)(3)§ 812.43 Selecting investigators and monitors.
  894. 812.43(c)(4)(i)§ 812.43 Selecting investigators and monitors.
  895. 812.43(c)(4)(ii)§ 812.43 Selecting investigators and monitors.
  896. 812.43(c)(4)(iii)§ 812.43 Selecting investigators and monitors.
  897. 812.43(c)(5)§ 812.43 Selecting investigators and monitors.
  898. 812.43(d)§ 812.43 Selecting investigators and monitors.
  899. 812.45§ 812.45 Informing investigators.
  900. 812.46(a)§ 812.46 Monitoring investigations.
  901. 812.46(b)(1)§ 812.46 Monitoring investigations.
  902. 812.46(c)§ 812.46 Monitoring investigations.
  903. 812.5(a)§ 812.5 Labeling of investigational devices.
  904. 812.66§ 812.66 Significant risk device determinations.
  905. 812.7(a)§ 812.7 Prohibition of promotion and other practices.
  906. 812.7(b)§ 812.7 Prohibition of promotion and other practices.
  907. 812.7(d)§ 812.7 Prohibition of promotion and other practices.
  908. 820.100(a)§ 820.100 Corrective and preventive action.
  909. 820.100(a)(1)§ 820.100 Corrective and preventive action.
  910. 820.100(a)(2)§ 820.100 Corrective and preventive action.
  911. 820.100(a)(3)§ 820.100 Corrective and preventive action.
  912. 820.100(a)(4)§ 820.100 Corrective and preventive action.
  913. 820.100(a)(5)§ 820.100 Corrective and preventive action.
  914. 820.100(a)(6)§ 820.100 Corrective and preventive action.
  915. 820.100(a)(7)§ 820.100 Corrective and preventive action.
  916. 820.100(b)§ 820.100 Corrective and preventive action.
  917. 820.120§ 820.120 Device labeling.
  918. 820.120(a)§ 820.120 Device labeling.
  919. 820.120(b)§ 820.120 Device labeling.
  920. 820.120(c)§ 820.120 Device labeling.
  921. 820.120(d)§ 820.120 Device labeling.
  922. 820.120(e)§ 820.120 Device labeling.
  923. 820.130§ 820.130 Device packaging.
  924. 820.140§ 820.140 Handling.
  925. 820.150§ 820.150 Storage.
  926. 820.150(a)§ 820.150 Storage.
  927. 820.150(b)§ 820.150 Storage.
  928. 820.160(a)§ 820.160 Distribution.
  929. 820.160(b)§ 820.160 Distribution.
  930. 820.170(a)§ 820.170 Installation.
  931. 820.170(b)§ 820.170 Installation.
  932. 820.180§ 820.180 General requirements.
  933. 820.180(b)§ 820.180 General requirements.
  934. 820.181§ 820.181 Device master record.
  935. 820.181(a)§ 820.181 Device master record.
  936. 820.181(b)§ 820.181 Device master record.
  937. 820.181(c)§ 820.181 Device master record.
  938. 820.181(d)§ 820.181 Device master record.
  939. 820.184§ 820.184 Device history record.
  940. 820.184(a)§ 820.184 Device history record.
  941. 820.184(b)§ 820.184 Device history record.
  942. 820.184(c)§ 820.184 Device history record.
  943. 820.184(d)§ 820.184 Device history record.
  944. 820.184(e)§ 820.184 Device history record.
  945. 820.184(f)§ 820.184 Device history record.
  946. 820.186§ 820.186 Quality system record.
  947. 820.198(a)§ 820.198 Complaint files.
  948. 820.198(a)(1)§ 820.198 Complaint files.
  949. 820.198(a)(2)§ 820.198 Complaint files.
  950. 820.198(a)(3)§ 820.198 Complaint files.
  951. 820.198(b)§ 820.198 Complaint files.
  952. 820.198(c)§ 820.198 Complaint files.
  953. 820.198(d)§ 820.198 Complaint files.
  954. 820.198(d)(2)§ 820.198 Complaint files.
  955. 820.198(d)(3)§ 820.198 Complaint files.
  956. 820.198(e)§ 820.198 Complaint files.
  957. 820.198(e)(2)§ 820.198 Complaint files.
  958. 820.198(e)(3)§ 820.198 Complaint files.
  959. 820.198(e)(4)§ 820.198 Complaint files.
  960. 820.198(e)(5)§ 820.198 Complaint files.
  961. 820.198(e)(6)§ 820.198 Complaint files.
  962. 820.198(e)(7)§ 820.198 Complaint files.
  963. 820.198(e)(8)§ 820.198 Complaint files.
  964. 820.198(f)§ 820.198 Complaint files.
  965. 820.198(g)§ 820.198 Complaint files.
  966. 820.20§ 820.20 Management responsibility.
  967. 820.200(a)§ 820.200 Servicing.
  968. 820.200(b)§ 820.200 Servicing.
  969. 820.200(c)§ 820.200 Servicing.
  970. 820.200(d)§ 820.200 Servicing.
  971. 820.200(d)(2)§ 820.200 Servicing.
  972. 820.200(d)(3)§ 820.200 Servicing.
  973. 820.200(d)(4)§ 820.200 Servicing.
  974. 820.200(d)(5)§ 820.200 Servicing.
  975. 820.200(d)(6)§ 820.200 Servicing.
  976. 820.20(a)§ 820.20 Management responsibility.
  977. 820.20(b)§ 820.20 Management responsibility.
  978. 820.20(b)(1)§ 820.20 Management responsibility.
  979. 820.20(b)(2)§ 820.20 Management responsibility.
  980. 820.20(b)(3)§ 820.20 Management responsibility.
  981. 820.20(b)(3)(i)§ 820.20 Management responsibility.
  982. 820.20(b)(3)(ii)§ 820.20 Management responsibility.
  983. 820.20(c)§ 820.20 Management responsibility.
  984. 820.20(d)§ 820.20 Management responsibility.
  985. 820.20(e)§ 820.20 Management responsibility.
  986. 820.22§ 820.22 Quality audit.
  987. 820.250(a)§ 820.250 Statistical techniques.
  988. 820.250(b)§ 820.250 Statistical techniques.
  989. 820.25(a)§ 820.25 Personnel.
  990. 820.25(b)§ 820.25 Personnel.
  991. 820.25(b)(1)§ 820.25 Personnel.
  992. 820.25(b)(2)§ 820.25 Personnel.
  993. 820.30(a)§ 820.30 Design controls.
  994. 820.30(b)§ 820.30 Design controls.
  995. 820.30(c)§ 820.30 Design controls.
  996. 820.30(d)§ 820.30 Design controls.
  997. 820.30(e)§ 820.30 Design controls.
  998. 820.30(f)§ 820.30 Design controls.
  999. 820.30(g)§ 820.30 Design controls.
  1000. 820.30(h)§ 820.30 Design controls.

About this dataset

Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.

Source: U.S. Code of Federal Regulations (eCFR); citation statistics from FDA inspection and warning-letter data