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Introduction................................................................................................ 225
% ?9 w2 L# W* U. R# g: nRegulatory Requirements Are Enforced by Law................................. 225
2 o8 X4 y8 c$ s0 g& {Make Regulatory Affairs Cost-Effective................................................ 225
( o F! J+ F1 \# @7 ?8 TRegulatory Requirements Improve Device Safety and) ]; ]- ? e v% ]% B# z
Effectiveness ........................................................................................ 2255 q% p7 s. E3 E0 O$ U
Regulatory Affairs Requires Good Judgment ...................................... 2269 `& R4 e- @" w/ x' G
FDA Overview and Authority................................................................... 226
0 O5 O, ]0 f+ D" uImportant FDA Jurisdiction Acts, History, and Assistance................. 227
; F' P+ B8 Z" N& AOnline Assistance .................................................................................. 227
2 ^! ]9 K8 R" C# w2 {% _/ J' RThe Basics: Short Discussion of Establishment Registration,- E7 c5 e8 ~8 r8 `
Device Submissions, Device Listing, and Device. I) d! h: ]3 r# \ Q
Classification............................................................................................. 2284 O$ E* N" ^3 D7 X1 ^- ~
Establishment Registration .................................................................... 228; I' v* T: W1 q5 I: J% }5 d
Device Listing ........................................................................................ 228, _* u% L$ o [( N! d
Device Classification ............................................................................. 229
" f$ Y7 U, W- j2 T1 [ ADevice Functional Classification........................................................... 230; y5 q7 T# p* ?( x; _& `
510(k) Premarket Notification .............................................................. 2303 e9 U* h7 }7 e8 h/ Q
Substantial Equivalence......................................................................... 231
5 G B- G$ L/ j" ?: KPremarket Approval Submission .......................................................... 232
! \ I# w. q" ~# {8 Z' M# K% LInvestigational Device Exemption and Supporting Studies ............... 232+ T; I% l) W8 X( @/ H
Third-Party Submission Review by Accredited Parties....................... 2332 K+ @! [8 z$ T: {9 {- \, z% `
Importing into the U.S.......................................................................... 2349 |4 b+ W) [" q3 | ?8 e q
Initial Importers................................................................................. 234" }. R! b& e. u5 x7 @, i
Exporting Devices ................................................................................. 234
" c5 L) O! Y6 I) [Certificates for Foreign Government............................................... 235
4 z( d1 P9 g7 M, PAdditional Regulations by Different States.......................................... 2350 P+ [! {% y4 A
Special Considerations............................................................................... 236
$ k) [. X' b( p6 s8 ? l& s, n! X; kExemptions from 510(k) and GMP Requirements.............................. 236/ H, l& \+ r, G5 k$ I
Class I Devices .................................................................................. 236
2 S7 l5 {4 z* mClass II Devices................................................................................. 236
q: ]# d: q8 {Special 510(k) ........................................................................................ 237
1 e/ D( x4 y) Z5 }8 DAbbreviated 510(k)................................................................................ 238, U1 f% `% g! A) Q# R8 v
De Novo
% r+ O$ |8 f% i.................................................................................................. 2384 O" W9 P1 Q3 B' ^$ ` ~3 q
Product Development Protocol............................................................ 239) h" J7 ~! ]' B$ s- e8 y
Humanitarian Use Device/Humanitarian Device Exemption............. 239/ y0 s. r" u6 W. T
Good Quality and Procedural Practices .................................................. 240
; d( Q8 D+ B u/ W$ f% ]Quality System Regulations (QSR)....................................................... 240- z, n4 c. W( s
Quality System Inspection Technique (QSIT)..................................... 241: h/ T& u$ J" M5 }% |
Good Clinical Practice .......................................................................... 241
- L/ R0 M. P# S; e; jGood Laboratory Practices ................................................................... 242- T0 J v! b4 ?4 r& q, Q6 |, O7 @+ D
Regulations ........................................................................................ 242
) k& D/ G9 E: s n; hPreclinical Studies.................................................................................. 242& c' t" r+ b/ K3 z/ M
Summary of Title 21 of the Code of Federal Regulations,
, W6 Y6 l; ] j) }8 s5 g9 C/ GParts 800 to 1299, for Medical Devices ................................................. 243+ u3 q* i/ {- s: P7 W
Part 800: General Requirements........................................................... 243
, r8 G1 ?# f. @, H8 rPart 801: Labeling.................................................................................. 243: _4 D2 @" J( H# J) ^; b5 C7 {
Part 803: Medical Device Reporting (MDR)........................................ 244
: @' q& S% E* r( B. s& MPart 806: Medical Devices: Reports of Corrections
. x, m/ a" z6 H f. B& [and Removals ...................................................................................... 246' `$ H7 |% e* M& Z/ W: ^3 E
Part 807: Establishment Registration and Device Listing for
/ a& }" U. Z. _, hManufacturer and Individual Importers of Devices ......................... 246: C" ~& k9 C/ x; n5 X" g, p
Part 808: Exemptions from Federal Preemption of State and U( g' ?: D ~' ^4 @
Local Medical Device Requirements .................................................. 248
3 ]; x: W) H$ s1 dPart 809:
# f2 Q) e* _# E# Z% F% AIn Vitro
* T X0 ]* n V4 j, p& Y9 R9 RDiagnostic Products for Human Use .................... 248
* z4 M1 [8 S% S+ U$ H4 O! HPart 810: Medical Device Recall Authority.......................................... 249% Z+ r! C' d2 A& k$ r
Part 812: Investigational Device Exemptions...................................... 250
9 o7 s, p& N9 \. [& s( }Part 820: Quality System Regulation.................................................... 257
5 i7 J* @6 c/ R' ^7 z1 @: L+ X- rPart 821: Medical Device Tracking Requirements .............................. 259
0 \$ c: `1 j( w c! yPart 822: Postmarket Surveillance ........................................................ 261: r+ L& U5 R. K" R5 ?5 d ]" T& Y
Part 860: Medical Device Classification Procedures ........................... 262 \. E, u& j8 Z+ E5 [
Part 861: Procedures for Performance Standards
7 Z) }7 u+ N# |- q+ a, EDevelopment ....................................................................................... 2637 g9 @" }% j t7 V0 K
Parts 862 to 1050................................................................................... 2643 R% i9 _3 r' R7 L w
Abbreviations.............................................................................................. 265
4 P7 n3 \# W/ m! `) q: |International and National Standard Abbreviations............................ 265( Q! h& P/ f' g0 ], j9 F, M1 N4 p
Regulatory Abbreviations ...................................................................... 265 |
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