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Introduction................................................................................................ 225
) G( }, J7 F$ n- k" fRegulatory Requirements Are Enforced by Law................................. 2253 I7 O8 p: S7 t) |/ ]
Make Regulatory Affairs Cost-Effective................................................ 225
7 }- f" M: A8 s; l+ ZRegulatory Requirements Improve Device Safety and
! n6 V. H2 J W3 [( ~% u9 ]5 I% t' L: DEffectiveness ........................................................................................ 225" ~% g0 d& z! }1 D3 V- O0 U1 Y w
Regulatory Affairs Requires Good Judgment ...................................... 226
9 K1 q4 G' C; y& e* `1 Q2 KFDA Overview and Authority................................................................... 226
5 S2 V: e% }9 FImportant FDA Jurisdiction Acts, History, and Assistance................. 227
7 e, P* S* K" b9 D, S5 qOnline Assistance .................................................................................. 227
! a2 \2 d* O, v- E6 Q9 g3 w( OThe Basics: Short Discussion of Establishment Registration,, v* c8 I3 w9 e* F2 {/ R! b. {; r
Device Submissions, Device Listing, and Device3 Y3 l1 E( L- R
Classification............................................................................................. 228
+ B0 r3 l& _/ x' ]& D0 Q) XEstablishment Registration .................................................................... 228
" e) Y( E+ ~7 E% U" D' bDevice Listing ........................................................................................ 228
, f7 D- L( _% S. S |: hDevice Classification ............................................................................. 229
$ R4 c: ]/ K0 U; j& k7 W. }% o+ IDevice Functional Classification........................................................... 230; |7 e0 b5 L; v7 ^
510(k) Premarket Notification .............................................................. 2301 ^! i0 w2 P/ @) K
Substantial Equivalence......................................................................... 231
6 y& M5 p$ R; v2 X8 WPremarket Approval Submission .......................................................... 232& T: k, c( B8 M+ A
Investigational Device Exemption and Supporting Studies ............... 232
) B( i" |1 {5 e: {% ~7 S! uThird-Party Submission Review by Accredited Parties....................... 233# q, a5 v8 V: b1 D
Importing into the U.S.......................................................................... 234
6 W9 u2 F+ x$ u3 O" Z$ ~Initial Importers................................................................................. 234
# D5 w! W4 u" T) ]+ U( O" SExporting Devices ................................................................................. 234: X: b1 U( ?* k( y, b: _
Certificates for Foreign Government............................................... 235
8 y8 s+ T2 t) U$ \Additional Regulations by Different States.......................................... 235
1 ?; X0 O1 W" H4 K& a0 R: jSpecial Considerations............................................................................... 236
' o; n4 @0 Z2 V2 m7 t7 @9 ?Exemptions from 510(k) and GMP Requirements.............................. 2368 J# N: X2 E' \6 d1 f3 D. R# H* Y9 V
Class I Devices .................................................................................. 236( D: e% I! u3 m! z: a* J& D" b
Class II Devices................................................................................. 236
9 ]( ~8 i* ~" G* ]7 DSpecial 510(k) ........................................................................................ 237- K! Q8 ~% v; B1 S3 a9 l7 i
Abbreviated 510(k)................................................................................ 238 f' I7 S" t( g3 Q! b
De Novo) E) B/ k+ x2 n0 q/ C! u. G
.................................................................................................. 2388 X$ |1 }7 N0 @' h* S, p8 S
Product Development Protocol............................................................ 239, c- q, B' ~! }3 z
Humanitarian Use Device/Humanitarian Device Exemption............. 239) t- d% o$ _: J
Good Quality and Procedural Practices .................................................. 240
" Z% S0 b. t1 l8 a+ u0 P3 u1 vQuality System Regulations (QSR)....................................................... 240
6 V7 T" v2 u% g& ~+ `" B0 SQuality System Inspection Technique (QSIT)..................................... 241& e8 e4 y1 ~. A' p
Good Clinical Practice .......................................................................... 241
% Z/ X. c; d% n; uGood Laboratory Practices ................................................................... 242
1 Q8 o' I1 ], z C7 D4 g w& J9 V) ~Regulations ........................................................................................ 242
) D" N# W) F1 L# H3 h0 pPreclinical Studies.................................................................................. 242/ n" J4 I& B3 K! @
Summary of Title 21 of the Code of Federal Regulations,5 O2 U2 E7 r# g8 t' U) R! G$ O, g
Parts 800 to 1299, for Medical Devices ................................................. 2438 s- w5 d6 s+ ~$ |9 B1 c
Part 800: General Requirements........................................................... 2432 Z+ N% m5 ~' H: n" v1 \
Part 801: Labeling.................................................................................. 243
; C$ R0 Z) y. W3 N$ y) jPart 803: Medical Device Reporting (MDR)........................................ 2447 z) ]. `+ Q d/ ~, z1 Z4 m
Part 806: Medical Devices: Reports of Corrections# q R S6 ]3 c0 C6 Z7 K
and Removals ...................................................................................... 2467 l# P2 S7 ~! v7 R6 Y
Part 807: Establishment Registration and Device Listing for
7 b. z2 ]1 i- L2 Y) }1 J2 x& u, W# KManufacturer and Individual Importers of Devices ......................... 2462 D% [6 W. ]+ D" W
Part 808: Exemptions from Federal Preemption of State and' U, Q; p# z: H/ ^# _
Local Medical Device Requirements .................................................. 248$ O. J2 {9 |1 ]' W$ E) I
Part 809:
$ T0 a+ {/ c; ?6 FIn Vitro
; ^4 _& [' i/ ~' mDiagnostic Products for Human Use .................... 2481 ?' n" V- c* b5 R; y+ W$ L
Part 810: Medical Device Recall Authority.......................................... 249% ^4 Q+ t# P1 R
Part 812: Investigational Device Exemptions...................................... 2506 _1 h/ b9 g8 @8 }
Part 820: Quality System Regulation.................................................... 257" J$ ~8 |% [' T+ d% h
Part 821: Medical Device Tracking Requirements .............................. 259
3 \3 I0 O, g8 g* m! A5 W: K9 KPart 822: Postmarket Surveillance ........................................................ 261
% V+ I7 B8 n8 o: B" J# Q6 EPart 860: Medical Device Classification Procedures ........................... 262
+ c' L* b4 J3 H5 a5 w. xPart 861: Procedures for Performance Standards' o6 p( _8 v# F |
Development ....................................................................................... 2634 C! r( A9 M, L$ c
Parts 862 to 1050................................................................................... 2645 a4 M: E& L0 k4 h& r
Abbreviations.............................................................................................. 265
% V u- W/ I' [+ QInternational and National Standard Abbreviations............................ 265! i. h$ A- n! S+ B# l
Regulatory Abbreviations ...................................................................... 265 |
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