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Introduction................................................................................................ 225" d! ~1 ?0 E2 S8 W$ i. c/ y, U
Regulatory Requirements Are Enforced by Law................................. 225% n E+ {. w5 @* X0 R
Make Regulatory Affairs Cost-Effective................................................ 2255 B5 \' l; E- \
Regulatory Requirements Improve Device Safety and
( J) m6 R4 d4 \1 f$ B( E6 Q/ ?Effectiveness ........................................................................................ 2255 i; X# u( {! g% U9 o
Regulatory Affairs Requires Good Judgment ...................................... 226" r9 p- I7 ]+ y6 N9 h& M$ X
FDA Overview and Authority................................................................... 226
0 i( S+ A9 \0 r& u7 oImportant FDA Jurisdiction Acts, History, and Assistance................. 227
" w: v2 K) ^ C0 x _8 U, }/ kOnline Assistance .................................................................................. 227
+ Z0 ]+ O" K, ]/ c+ j. ~The Basics: Short Discussion of Establishment Registration,* d. R1 Q" x+ T/ m8 J
Device Submissions, Device Listing, and Device
8 y/ c8 ~: P! R: m# AClassification............................................................................................. 228
9 K* Q2 O$ A) _Establishment Registration .................................................................... 228
7 ~0 _* i" v6 P% _/ E$ UDevice Listing ........................................................................................ 2285 a% k I9 v1 e2 _+ `
Device Classification ............................................................................. 229
8 P6 l1 w5 C' P0 NDevice Functional Classification........................................................... 230
2 ?$ p" F$ s- K: d6 V510(k) Premarket Notification .............................................................. 2302 K- I) t! f$ r+ Y% v
Substantial Equivalence......................................................................... 231
) N1 o" j5 D$ z: v3 yPremarket Approval Submission .......................................................... 2322 x' U1 G0 U/ c- p2 d9 J& }
Investigational Device Exemption and Supporting Studies ............... 232' H7 C. i! t$ \* Y- K
Third-Party Submission Review by Accredited Parties....................... 233) b$ X) w8 K9 k: m7 m
Importing into the U.S.......................................................................... 2342 d! @3 |7 \% W- }" ~
Initial Importers................................................................................. 234: ^1 M2 B* f; w8 u
Exporting Devices ................................................................................. 234
% \+ G- _1 F" B Y; H# \Certificates for Foreign Government............................................... 2351 O% o. c# j5 c" h, k2 T0 V
Additional Regulations by Different States.......................................... 235
0 V# @$ v0 d M; i, `Special Considerations............................................................................... 236
; G: R4 f# D1 Q- t5 r' p1 c fExemptions from 510(k) and GMP Requirements.............................. 2368 W/ D6 O" q4 x/ Y! k+ V
Class I Devices .................................................................................. 236
; h" }/ Q( r4 h T: i) R( YClass II Devices................................................................................. 236
9 |2 g# P0 s$ p# j! a- ~Special 510(k) ........................................................................................ 237
. P6 r& ~7 g5 vAbbreviated 510(k)................................................................................ 238! r* |2 H6 `5 e. y
De Novo. ~$ [* c# W6 X! \
.................................................................................................. 238
1 D' J/ L Y Z0 t6 NProduct Development Protocol............................................................ 2390 |. R/ i3 J1 `; I4 A; c
Humanitarian Use Device/Humanitarian Device Exemption............. 239
5 N8 D9 z) J4 m2 Z. SGood Quality and Procedural Practices .................................................. 240+ O* |+ t8 _, @/ S7 P& g' C ?
Quality System Regulations (QSR)....................................................... 240 ^# R1 j) }) |& h, C
Quality System Inspection Technique (QSIT)..................................... 241
* o) h4 Y7 U" p% j3 hGood Clinical Practice .......................................................................... 2414 g# U/ B4 C5 }7 F8 y# p. k) |
Good Laboratory Practices ................................................................... 242; {" Y4 H1 O6 n |- q& a0 H
Regulations ........................................................................................ 2423 e, d, K. c, h3 d3 J8 N
Preclinical Studies.................................................................................. 242! T4 T; F/ r' R# X* n k
Summary of Title 21 of the Code of Federal Regulations,/ N( |! C8 c8 g5 t" u7 }
Parts 800 to 1299, for Medical Devices ................................................. 243
6 h2 x+ a2 v" s" q& {; T1 u# f6 @Part 800: General Requirements........................................................... 243: m u w8 g( j" e3 P+ V& f! ~% `5 k# t
Part 801: Labeling.................................................................................. 243
) D! v/ X& W. _9 O9 w! v: QPart 803: Medical Device Reporting (MDR)........................................ 244
/ J# w2 p: ^4 }3 V% E0 `Part 806: Medical Devices: Reports of Corrections
; `$ ^; g) b# X- a [9 S5 C2 Band Removals ...................................................................................... 2464 b0 M; U: t* p! r& m7 ^
Part 807: Establishment Registration and Device Listing for+ J1 p. I8 E$ c
Manufacturer and Individual Importers of Devices ......................... 246
! k% R# N7 y9 Y: N3 O% ~; C ^8 e/ iPart 808: Exemptions from Federal Preemption of State and) Z; O4 o+ z; T* D! B2 s9 s
Local Medical Device Requirements .................................................. 248
( [6 F% {& x4 H1 `Part 809:
) P. w F) f. b+ k/ D5 L+ cIn Vitro5 y! @ P/ e& v2 J4 I) [& l# w* V
Diagnostic Products for Human Use .................... 248
" I! q7 k w& R0 ?Part 810: Medical Device Recall Authority.......................................... 249
& d8 ~9 ~0 b6 j A ?" Z7 JPart 812: Investigational Device Exemptions...................................... 2502 Q5 E& L( @% O7 O
Part 820: Quality System Regulation.................................................... 257
. w. O- L# v. o0 z8 hPart 821: Medical Device Tracking Requirements .............................. 2594 X2 S4 ]3 h+ V. \! q( t+ H
Part 822: Postmarket Surveillance ........................................................ 261
& l2 Z4 K3 \- U4 X* PPart 860: Medical Device Classification Procedures ........................... 262
% C2 T& `$ m" o; o5 `3 gPart 861: Procedures for Performance Standards
0 @# F/ K2 j: s q9 u4 a/ ADevelopment ....................................................................................... 263
: n2 L) ^7 r5 j" B% UParts 862 to 1050................................................................................... 264- j2 c( |( u& \
Abbreviations.............................................................................................. 265
4 W2 O, ]1 ?7 ^1 H+ \8 k' w- V WInternational and National Standard Abbreviations............................ 265
# f, V3 G) r$ c+ vRegulatory Abbreviations ...................................................................... 265 |
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