本ガイダンスは 1997 年 2 月 27 日に FDA の Good Guidance Practices
Contents
1.2.
3. 45 224
4. YES NO N A YES NO N A
5. 1
6. 820 130 e Section 801 150
7. 21 CFR 809 10 b 15 FDA 809 10
8. 17 196 16 CFR Part 1500
9. 6 1 X FDA a
10. 2 IVD
11. Section 706 FD amp C Section 502 706 1976
12. NO GMP
13. 57 290 no dh CSA UL IEC
14. 2 i No
15. 1 X 801 5 186 1
16. N 1 2 21 CFR 801 62 g k 10 189 801 109 M
17. FD amp C DSMA DSMA Q amp wA FDA
18. I 6 NR
19. lt FDA
20. GMP 2 51 280 40 000 WordsJ
21. 54 293 ambienD 1 Makes provisions for Servesto At the time of In conjunction wit
22. FDA RN 6 Re SAN SI OO oo 0
23. 46 25 EA EE
24. 1 1 2 29 208 820
25. FDA 9
26. 56 95 2 PLANT TRAFFIC NO FISHING ENTERING HIGHWAY OFF BRIDGE
27. Section 820 25
28. 6 OFD amp C SectionS18 Section 519 FDA Section 502 a
29. CDRH 6 08PC Eh CN GR CDRH Inc i CR CDRH
30. 167
31. Oe critical GMP C 1 MR must J i
32. HFZ 300 h I ILLA II II A III B VI RR ni RR ad
33. N GMP 1 GMP NM NN 820 5 A I
34. 161 Section 201 k i NN EE ES MI RE OR 0 Section 201 m 1
35. 1050 10
36. G g 1 G 1 g 2 1 2 3 1I IL A II II A III B VI
37. UN Ep 820 120 ay 820 120 a 2 820 120 e 820 20 a 820 80 820 160 CC I wet
38. dB ie gt 766 16 CFR Part 1500
39. Gi NN 42 9 I VI 10 S81040 11
40. 801 403 EDA 0SHYZN9 2 13 tS 801 405 801 430
41. 31 210 2
42. iv WM S1040 11 v e G 7mm 50mm
43. 12 et bo ii 801 150 e 1 mf ii ii iv 2
44. 820 80 820 120 820 5 820 40 Ro RI
45. GMP EN OO 25 204 GMP GMP PART 820 S 1 1 2 3 4 3 6 7 8 10 NC NC NC NC NC NC NC NC NC C
46. UL EC C FDA II 2 310 k 22 201 IDE 21 CFR PART 812 FDA TI
47. I VI II 0 gt TI NE i IIa 41 2 5X10 Wcm x 1 ni Illa oO 2 5X10 Wcm
48. 182 FD amp C Section 502 2
49. X 1020 31 37 216 PBL X X X X 1020 32 X X
50. 21 CFR 801 Subparts A E GMP Section 820 130 820 160 820 161 33
51. OTC 801 60 xW 40 40 801 61 188
52. 8320 181 182 24 203
53. CDRH CDRH CDRH CDRH A John C Villforth IN FD amp C 502
54. IE3 3 O mg mg qdl L U ny f
55. 38 CFR A a 2 3 B 0 AFS CT 3 39 218 21 CFR 1040 10 g g S10102 S1010 3 1 7 7 Ila Ila
56. GMP 27 206
57. 36 5 NH X XX X 1020 30 X 1 21 CFR 1020 30 X 1984 11 29 X
58. _ _ _ 1020 1 1020 20 X
59. 20 199 dh 9 st 3 501 K 1 FDA
60. 20837 62 241 coc 68 VO
61. OS I 820 121 3
62. FDA FDA FDA DSMA 800 638 2041 301 443 6597 2 Joseph S Arcarese 777 H76 Labeling Regulatory Requirements for Medical Devices HHS FDA 89 4203 1989 8 43 Regulatory Requirements for Medic
63. 5 Ila 1 VI VI 1 Gi VI 2 XX 6
64. 2 20 25
65. FDA 86 4163 FDA 86 4201 FDA 86 4202 FDA 86 4203 FDA 86 4204 FDA 86 4205 Medical Devices FDA 83 4159 PB 86 184942 AS 16 95 Registration and Listing Regulatory Requirements for Medical Devices April 1986 1986 4 FDA 83 4163 PB 86 191939 AS 11 95 Problem Definition Study Rubella Antibody Testing PB 86 131933 AS 9 95 40PP To Cement or Not to Cement or Has the FDA Approved the Use of This Device FDA Labeling Regulatory Requirements for Medical Devices GPO 017 012 00327 3 2 75 PB 86 184348 AS 11 95 An Imterlaboratory Comparison of Analytical Methods for Ethylene Oxide PB 86 1818S6 AS 9 95 Accidental Breathing Systems Disconnections January 1986 Final Repor
66. 1 2 0 1
67. 2 49 26 0 RE NR AR 2 5 GMP
68. OO A 2 0 No GMP GMP
69. i 18 a
70. 81040 11 1 IL A II II A II B VI
71. FDA PMA IDE IDE FDA
72. FD amp C FDA FDA 310 k 21 CFR Section 807 39 21 CFR Section 807 97 FDA FDA IDE PMA MM NM Section 301 1 Section 515 IIDE 320 g PMA 62 184
73. Gv NS CR I 6 20 i IIla 2 5 X10 Wem Gi II a CI 2 5X10 Wem
74. 1 16 95 lt ii ii ii 809 10 B nh 3
75. IDE 801 1 801 109 23
76. IVD IVD 21 CFR Part 809 21CFR 809 10 A IVD
77. 801 125 801 127 801 130
78. CFR 21 Part 21 CFR PART 801 21 CFR PART 809 21 CFR PART 812 180 GMP 21 CFR PART 820 21 CFR PART 1010 CC i FD amp C FDA OFD amp C Section 201 k OFD amp C II 2 OFD amp C V
79. PB 88 121793 AS 19 93 Medical Device Reporting Questions and Answers 60 289 FDA 88 4227 FDASS 4228 FDASS 4229 FDAS89 4158 1988 2 PB 88 192737 AS 14 9 Export of Medical Devices A Workshop Manual 1988 9 GPO 017 012 00338 9 10 00 PB 89 119663 AS 28 95 Import of Medical Devices A Workshop Manual 1988 9 GPO 017 012 00337 1 8 50 PB 89 119671 AS 21 95 Applications of DNA Probes for the Diagnosis of Human Infectious Diseases An Overview DNA 1988 9 GPO 017 012 00340 1 2 00 PB 89 120497 AS 15 95 Premarket Notification 510 k Regulatory Requirements for Medical Devices S10 k 1988 11 GPO 017 012 00342 7 3 75 61 240
80. 801 405 801 408 801 410 801 415 0 05
81. A 1 1 S 3 II za 77 OE Ila 2 5X 103Wem A g 1 G 1 1 3 IIIla G Ila 2 5 10 Wcm B 2 nx 1
82. 801 110 801 116 O 801 119 809 10 190 801 122
83. Makes provisions for Be provided for 55 234 2 3 i
84. FPLA 5 EPLA OTC RCHSA RCHSA 358 h DHHS DHHS FDA FDA FR
85. onm off MN ON POWER ON ON POWERJ ON OFF on on 2 SSLINO92 53 29 OO YN2 E
86. FDA S10 K I 21 CFR 807 81 807 97 310 k FDA 310 k 510 k
87. 8 801 6 8301 15 O 2
88. NC a 20 1 IIla Gi 0 MM RW 1 3 1 EB 44 b EF I Ila II IIa S1040 10 TIa
89. MIL STD 129H MIL STD 129H X GG G 00650a X Fed Std No 123 MIL STD 129 FDA 47 426 MIL STD 129H MIL STD 129H
90. SN 15 194 O16 CFR PART 1500
91. NSN NATO gt NSN NATO CZ LOGMARS 1982 7 1 LOGMARS Logistics Application of Automated Marking a
92. 165 lt ml 21 CFR Part 801 801 1 gt 801 4
93. FDA FDA PMA PMA IDEB 21 200 FDA FDA IDE IRB IDE IDE
94. 81040 11 iD 1 Gi g 81040 11 g 1 GD 1 GD 2 1 2 3
95. SAKE NN 81040 10 MG I Ila II IIla 50 FR 33702 1985 8 20 23 1040 20 200 400nm 1040 20
96. 5 95 Selected Research in Microfiche NTIS FDA HFZ CDRH 1 35 GPO PB CDRH Superintendent of Documents U S Government Printing Office Washington D C 20402 National Technical Information Service Springficld VA 22161 2 Center for Devices and Radiological Health Food and Drug Administration HFZ 265 5600 Fishers Lane Rockville MD 20857 FDA 84 4190 FDA 84 4191 FDA 84 4192 FDA 85 4169 FDA 85 4192 FDA 85 4193 FDA 85 4194 FDA 85 4195 FDA 85 4196 FDA 85 4199 FDA 86 4159 An Investigation of Cerebrospinal Fluid Shunt Valves Test Results for Twenty Five Valves Final Report Phase III 25
97. 28 207 820 40 820 1200 1 1 1
98. 3 IIla Gi mb B GD 2 1 3 IIIb OT 3 IV SS g G 2 1 3 IV 2 EO KH LL IV 219 2
99. 30 209
100. 9 iv Illb IV wi d VI 1 vii VI 2 X 7 1I VI
101. X
102. 2 820 100 0 FDA
103. 801 417 21 CFR 2 123 801 425 801 420 801 421 14 9 801 427 801 430 TSS
104. Section 820 20 2 Section 820 40 SRI NG DT FDA GMP
105. 52 MC TR RR I CN POWER ON HEAT 3 READY
106. 90 FDA FD amp C 310 FDA 1976 5 28 1 II TI 1976 5 28 FDA 1 II 310 k 5s10 k FDA
107. _ ______ N A FDAS6 4208 FDA 86 4209 FDA 86 4210 FDAS6 4211 FDA 86 4212 FDA 86 4213 FDAS7 4002 Medical Device Federal Register Documents 1986 6 An Introduction to Transcutaneous Electrical Nerve Stimulation TENS 1 95 CX PB 87 115481 AS 13 95 TENS PB 87 107884 AS 1 A Comprehensive Review of Hemodialysis Equipment and Related Peripheral Support Equipment Efficacy Efficiency and Safety 1I 1I PB 86 245404 AS 28 9 Hemodialysis Equipment and Practices in Massachusetts Protocol for the Study ofHlemodialysis in Ohio PB 86 245370 AS 22 95 i Participation in Dialysis System Investigation PB 87 108825 AS 24 95 0 Resistant Lenses Questions
108. iv IIb A wi d VI 1 vi VI 2 X 8
109. 1 MDR MDR FDA 3 GMP
110. PB 84 207042 22 95 Medical Device GMP Guidance for FDA Investigators FDA GMP Problem Definition Study on Liquid Crystal Forehead Temperature Strips PB 84 187483 16 95 Toxic Shock and Tampons Toxic Shock Syndrome BMD Standards Survey 1982 International Edition 1982 PB 85 171155 AS 34 95 An Overview of the Medical Device Reporting Regulation PB 86 109709 AS 9 95 Surface Cracking of Polyurethane Tubing Resultng from Subcutaneous Implantation in Dogs PB 83 171619 AS 11 95 Medical Device Problem Reporting and the Health Care Professional Medical Device Establishment Registration Information and Instructions PB 86 123726 AS 9 95 8 pp Investigational Device Exemptions Regulatory Requirements for
111. kk 17 0 hi bi kk 19 kk 20 501 K kk 21 Ro NN Rn i 21 510 K 22 0 0 RU 2 23 GMP 23 AP 24 27 kk 30 31 2 ES 0 P 33 KOOO 1 34 11 NHN 34 2 Et 35 1 lt Y Ss 36 38 MARUISRMIMSUNRS2RNUCN 46 kk 47 0 7 90 0 027 47 47 i Fh 49 VY 46 49 2 EE 50 a anan 51
112. 1986 1 PB 86 185204 AS 22 95 a FDA 89 4203 Thomas Cardamone 1989 8 FDA 86 4203 20857 174 1982 10 CDRH CDRH
113. FDA RCHSA FDA 21 CFR PART 1010 FPLA FD amp C FEPLA 21 CFR Part 801 RIN FDA 21 CFR Part 1010 FD amp C Section 201 FD amp C V
114. 4 4 a NY DR
115. Part 861 IDE Part 812 IDE Part 812 IVD IDE 19 96 IVD
116. Ui ul CU 801 62 OTC 231 68
117. 2 A a FD amp C
118. FT 2 FDA O NC ee FDA CFR 34 13 RE 21 CFR 1010 3
119. 1997 2 27 FDA Good Guidance Practices GGP FDA GGP 170 RH EES 171 CDR CDRH GPO NTIS GPO PB NTIS
120. 4 CDRH a CDRH 35 214 CDRH 00 Title 21 Chapter 1 Subchapter J
121. lt E 2 RCHSA Section 358 X 1968 E 21 CFR Part 1000 E
122. 0 2 ml GMP QAJ RE NC GMP NN Pe NPC Ce CRT GMP
123. X 1020 40 1 X X XX XX XX 1040 10
124. 81010 2 2 SN RN E 1010 2 81010 3 8 3 G 0910 0176 150 FR 33688 1985 8 20 50 FR 42156 1985 10 18 S1040 11 amp 81040 10 ONS Ne
125. b 820 121 32 809 10 a GMP
126. 2 50 29 1
127. kk kk 58 Y ES FDA 14 3 FD amp O Section 201 Section 302 D 1 2 FPLA FD amp C
128. YES NO N A 58 9 YES NO N A YES NO NA FDA GMP
129. 2
130. Proceedings of the First International Conference of Medical Devices Regulatory Authorities ICMDRA June 2 6 1986 1 CMDRA 1986 6 2 6 PB 88 123005 AS 25 95 Have a New Medical Device Medical Devices Standards Activities Report PB 88 123641 AS 19 95 Regulatory Requirements for Devices for the Handicapped PB 88 123013 AS 12 95 An Introduction to Medical Device Regulations Classifying Your Medical Devices In Vitro Diagnostic Devices Guidance for the Preparation of 510 k Submissions 510 k GPO017 012 00331 1 3 50 PB 88 121801 AS 14 95 Import and Export Regulatory Requirements for Medical Devices 1988 8 GPO 017 012 00336 2 2 25 PB 89 121839 AS 13 95 Review and Summary of Hemodialysis System Investigative Reports from California the District of Columbia Massachusetts and Ohio
131. C 120 amp 100 120 181 121a 182b 120a 121b 120d 121c 120b 120c 120e 160 161 26 205 21 CFR 801 807 809 181
132. and Answers June 1972 39 96 PB 86 242427 AS 11 95 FDA 87 4179 FDAS7 4188 FDA 87 4199 FDAS7 4214 FDA 87 4215 FDA 87 4217 FDA 87 4218 FDA 87 4219 FDAS7 4221 FDA 87 4222 FDA 87 4223 FDA 87 4224 FDASS 4160 FDASS 4223 FDASS 4226 1972 FDA 81 4002 1987 9 PB 88 123021 AS 12 95 Device Good Manufacturing Practices Manual November 1985 GMP 1985 11 1987 11 GPO 017 012 00330 3 18 00 PB 88 132139 38 95 Need Help With Medical Device Regulations Contact DSMA DSMA FDA 84 4188 Medical Device Establishment Registration Information and Instructions May 1987 1987 5 FDA 85 4199 PB 88 123666 AS 12 95 Premarket Approval PMA Manual PMA 1986 10 GPO 017 012 00329 0 7 50 PB 87 154363 AS 18 95 Orthopaedic Device Labehng Guideposts for Concerned Physicians 1987 1
133. R A NC ON i PD
134. al Devises A Workshop Manual 6 NN FPP 1 ND EOIN TI i 2 SR 4 GE 5 kk 6 21 7 kk 7 OTC kk 9 BU 10 ICH PP 12 kk 13 15 OA ON ON TT Un ORR OR 15 RN 15
135. h NO 6 0 5 CC ON NN I
136. h Carried out in Comes up to Will also serve as a chance to Due to the fact that Will be sure that will Available through the use of Care should be used so as not to Be provided for positive determination Causes power to be applied to When And Perform Reaches May Because Ensure BN Be careful T Switches power to Makes provisions for
137. nd Reading Symbology MIL STD 129H UPC Universal Product Code LOGMAR MSN 48 ml MDR 40 FDA
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