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Introduction................................................................................................ 225
; Q$ n! N: S9 h# x' T5 ]Regulatory Requirements Are Enforced by Law................................. 2251 I6 x' |& \7 d" _$ z+ \; t8 u$ o& z
Make Regulatory Affairs Cost-Effective................................................ 225
. o2 [- t4 f8 p0 Q) c- S8 ARegulatory Requirements Improve Device Safety and
( O' k$ W$ D! |! I- D6 y, \/ YEffectiveness ........................................................................................ 2256 y: ^5 v, Q1 o# f) R& X
Regulatory Affairs Requires Good Judgment ...................................... 226
. k6 B( c' S. z% C+ f2 v' lFDA Overview and Authority................................................................... 226
) J& T+ U+ {5 ~& DImportant FDA Jurisdiction Acts, History, and Assistance................. 227& s( V; i9 [% I( O# w! G/ N
Online Assistance .................................................................................. 227! R9 ^* N8 E- z/ {5 M
The Basics: Short Discussion of Establishment Registration,
9 M6 ]" @& O3 FDevice Submissions, Device Listing, and Device
0 T+ q6 q8 n. Z0 g1 ~Classification............................................................................................. 228
, a& h5 @- r9 z0 a' gEstablishment Registration .................................................................... 228
, r& |5 x k- x/ ~: @8 mDevice Listing ........................................................................................ 228
# Z Z% o- {0 c7 A' n1 u5 s- cDevice Classification ............................................................................. 229; i1 d' |% V4 {7 O
Device Functional Classification........................................................... 230/ b: @8 j. s. R1 S5 M' u* h1 Y. r
510(k) Premarket Notification .............................................................. 230
# i% G: ~. t: U$ T Q+ OSubstantial Equivalence......................................................................... 231) V6 `4 F$ w+ B" {# I+ E) s( F4 _
Premarket Approval Submission .......................................................... 232
+ v: n" C, c9 U! Y( j$ K/ NInvestigational Device Exemption and Supporting Studies ............... 232; }: A9 }0 [) ~; d: [: ^
Third-Party Submission Review by Accredited Parties....................... 233
2 _7 D; U( E( `3 y9 N0 P% OImporting into the U.S.......................................................................... 2347 B' C8 h( d8 F! v. `2 Q
Initial Importers................................................................................. 2348 Q* ^9 \2 @& a9 i8 A0 ]
Exporting Devices ................................................................................. 234
1 [' V- B$ x. S" r7 [Certificates for Foreign Government............................................... 235% [9 h6 U/ N9 W9 g+ |! k
Additional Regulations by Different States.......................................... 235; h+ O, J0 I& S! D# p4 ?
Special Considerations............................................................................... 236
; X1 h( i. D" }. y1 {Exemptions from 510(k) and GMP Requirements.............................. 236( N" p/ }3 t3 e$ `' w, J
Class I Devices .................................................................................. 236
; f6 T" o, f" K# L# L* P8 ]- pClass II Devices................................................................................. 236& y% ^0 w2 y" Q8 B( S
Special 510(k) ........................................................................................ 237% |6 ]1 D3 B n) n8 J
Abbreviated 510(k)................................................................................ 238( h1 p9 X5 _: Q9 c& e1 @6 G3 c
De Novo
) f( y. p$ w8 A" s.................................................................................................. 238& q# F( E0 O- J* A$ j
Product Development Protocol............................................................ 239
; e p6 J3 S' M- o$ h2 ]Humanitarian Use Device/Humanitarian Device Exemption............. 239
6 W& ?8 |1 v& A. V: H. C) qGood Quality and Procedural Practices .................................................. 240: F% Z) w% J: |" S* I1 o8 }# e
Quality System Regulations (QSR)....................................................... 240
3 d! m* P, s$ W# V; E! d4 O4 bQuality System Inspection Technique (QSIT)..................................... 241
# q; L% L( f* ^, s, gGood Clinical Practice .......................................................................... 241" j3 C; C" o: |+ w1 p" s9 {5 _
Good Laboratory Practices ................................................................... 2424 w) A4 s) P; g6 x( B' o+ X
Regulations ........................................................................................ 242
: g4 P5 |2 K, h$ p& ^% IPreclinical Studies.................................................................................. 242
' ]. f# |( l, v+ y+ QSummary of Title 21 of the Code of Federal Regulations,! N; \1 _) K1 C) b' r- V3 v
Parts 800 to 1299, for Medical Devices ................................................. 243
' u; O' m& U$ t- _2 zPart 800: General Requirements........................................................... 243; f0 V4 d. O8 S6 ]; _3 T& M( z
Part 801: Labeling.................................................................................. 243 L: b/ @* Y1 X
Part 803: Medical Device Reporting (MDR)........................................ 244
$ F& {$ r, _2 W& A4 n. }Part 806: Medical Devices: Reports of Corrections
5 @% T( j% \& n. d8 \+ Yand Removals ...................................................................................... 2461 j% P; {7 g+ X, I, n, J3 e
Part 807: Establishment Registration and Device Listing for
2 V2 S) V% D+ l0 W; lManufacturer and Individual Importers of Devices ......................... 2466 u3 ?, \! a. G% {- S4 a8 x
Part 808: Exemptions from Federal Preemption of State and; p" ?7 N0 L7 b# |0 \# u0 W
Local Medical Device Requirements .................................................. 248 V, U% `4 @$ Z: D& E% Z# J
Part 809:3 x: E/ m! b( {: k$ ~2 e( Q' `
In Vitro
4 z# p& X* @5 {( {7 ~+ SDiagnostic Products for Human Use .................... 2481 s) }! Y7 J) e) J, m
Part 810: Medical Device Recall Authority.......................................... 249) R1 D5 n/ i# I1 J8 i2 v1 n5 ~
Part 812: Investigational Device Exemptions...................................... 2505 d/ |# U& A$ q
Part 820: Quality System Regulation.................................................... 257
/ j* |# Q1 u* j/ R6 Q7 X- C6 pPart 821: Medical Device Tracking Requirements .............................. 259% F9 O7 x( j3 b
Part 822: Postmarket Surveillance ........................................................ 261
7 C5 R9 t* u; B; TPart 860: Medical Device Classification Procedures ........................... 262) G: k( l, T. d6 H: F- }8 |1 |/ }
Part 861: Procedures for Performance Standards& J% {, r! G8 d! d$ n! V; w# w
Development ....................................................................................... 263$ p' v# C+ H" Z
Parts 862 to 1050................................................................................... 2649 ^. N! z$ J) e" q& T
Abbreviations.............................................................................................. 265
2 \) T; M/ a: O' m! q7 |6 N% d2 C# `International and National Standard Abbreviations............................ 265
d( M4 f1 }3 z! \7 _' c$ \$ d1 k4 g5 RRegulatory Abbreviations ...................................................................... 265 |
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