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Introduction................................................................................................ 225
9 S1 T9 n( p( S; DRegulatory Requirements Are Enforced by Law................................. 225
3 v/ d9 ?* {3 E6 L) o* TMake Regulatory Affairs Cost-Effective................................................ 225* Q) \- G+ H' l' ?* [
Regulatory Requirements Improve Device Safety and: o, r/ @7 ^; g) t0 C7 k- y8 k- w
Effectiveness ........................................................................................ 2255 ]- k3 r0 m9 S, `1 G
Regulatory Affairs Requires Good Judgment ...................................... 226
* t j4 N0 m# \$ _FDA Overview and Authority................................................................... 226$ ?; Z: h8 ^9 h& h& k0 J- h! e$ C
Important FDA Jurisdiction Acts, History, and Assistance................. 227
+ ^! c _/ I- ?7 p3 |Online Assistance .................................................................................. 227
. @5 h3 D# V E' w, N R5 F$ tThe Basics: Short Discussion of Establishment Registration, V4 @' e# [: I( J& u5 \6 j
Device Submissions, Device Listing, and Device+ V& o5 {6 W! I" p6 h) I
Classification............................................................................................. 2281 v# Y& D1 p' l% `) f7 \
Establishment Registration .................................................................... 228
7 C) B& y+ n* n. L$ i5 HDevice Listing ........................................................................................ 228
7 E3 G7 V: c! r. g1 kDevice Classification ............................................................................. 229 v/ `: L! `7 w. ^
Device Functional Classification........................................................... 230. U( q+ i4 [7 ^
510(k) Premarket Notification .............................................................. 230
3 N, t% f$ J6 ^- M |Substantial Equivalence......................................................................... 231
" n2 h1 Y: n; z' {- n4 oPremarket Approval Submission .......................................................... 232$ f" x1 A$ T: W: A' g
Investigational Device Exemption and Supporting Studies ............... 2322 I$ N2 ]% |+ U, T9 ~8 a3 b
Third-Party Submission Review by Accredited Parties....................... 233$ c% |. b; O$ X, @6 l% v1 f1 o
Importing into the U.S.......................................................................... 234
, ]1 M: p0 f; WInitial Importers................................................................................. 234
& p* U: |# q( U* A! @( `, S! H) _* |. mExporting Devices ................................................................................. 234
. y- P ]7 d8 v0 j! p/ Z) D3 XCertificates for Foreign Government............................................... 235
6 W7 t9 ~$ r( ` a! RAdditional Regulations by Different States.......................................... 235( ?& N+ p9 W+ S B4 i4 D
Special Considerations............................................................................... 236* X9 o9 d+ Q$ M4 p4 j: f
Exemptions from 510(k) and GMP Requirements.............................. 236; F! Q# j% q7 A, |
Class I Devices .................................................................................. 236
, ~$ R# }6 G$ b* Y, F. I! i7 KClass II Devices................................................................................. 236* Q/ {7 W: n$ e
Special 510(k) ........................................................................................ 237
' U+ G5 E/ \7 J8 M ]8 EAbbreviated 510(k)................................................................................ 238
& `+ E2 {% W8 @De Novo
* o5 d0 ]6 t( L! }( J.................................................................................................. 2381 q+ f F, {3 @% {
Product Development Protocol............................................................ 239
5 [# Z+ M, d9 a- K8 y rHumanitarian Use Device/Humanitarian Device Exemption............. 239+ x3 C( }3 D5 H% s, Z
Good Quality and Procedural Practices .................................................. 240
9 L7 y$ y' W& R- r fQuality System Regulations (QSR)....................................................... 240% t" s* Q. l; m; A! s' R9 s
Quality System Inspection Technique (QSIT)..................................... 2417 X: U9 u* s& {, \- _4 _$ f8 K
Good Clinical Practice .......................................................................... 2414 } m5 a! v! w; ~+ C" O
Good Laboratory Practices ................................................................... 242) j" i* x$ r# P' b5 U( A. @; z
Regulations ........................................................................................ 242
, w J7 I/ A9 L$ X% cPreclinical Studies.................................................................................. 242# M" L# z$ N6 D7 T6 P( h# F
Summary of Title 21 of the Code of Federal Regulations,
( t! V3 x. K. }7 }! lParts 800 to 1299, for Medical Devices ................................................. 2434 T, _6 t2 P) B6 D
Part 800: General Requirements........................................................... 243* f1 X6 ?0 J; o6 i% G: i
Part 801: Labeling.................................................................................. 243( u5 B) }: j7 {
Part 803: Medical Device Reporting (MDR)........................................ 244% Y& X+ x1 K* C" s# z
Part 806: Medical Devices: Reports of Corrections5 T6 ?0 n# g. r# p" U7 O
and Removals ...................................................................................... 246
5 I- Q) X) F: y/ \0 E; Y3 ?! NPart 807: Establishment Registration and Device Listing for
$ |- F) S& T5 }5 |9 @7 y6 OManufacturer and Individual Importers of Devices ......................... 246" G: Y/ `' Z) u( }2 [
Part 808: Exemptions from Federal Preemption of State and4 y- p0 f; B: t: ~# T
Local Medical Device Requirements .................................................. 2483 t. M& U1 }. E* ]. F
Part 809:
' O: B; M% ~0 Z8 u6 S2 ]8 |* UIn Vitro2 q" b6 b$ M, @0 C! n" p
Diagnostic Products for Human Use .................... 248( q& {6 y& |( E$ ]4 I
Part 810: Medical Device Recall Authority.......................................... 249
' g4 e7 i$ L5 _ E2 f. `4 VPart 812: Investigational Device Exemptions...................................... 250
2 {: O" g% z( h. uPart 820: Quality System Regulation.................................................... 257
& s% @% [' D6 {0 Z/ APart 821: Medical Device Tracking Requirements .............................. 259( m, ]" T- z0 c7 ~2 M: }
Part 822: Postmarket Surveillance ........................................................ 261: p! l {9 q6 E1 f% n- @( i
Part 860: Medical Device Classification Procedures ........................... 262( q8 x: ~; E q
Part 861: Procedures for Performance Standards
+ U" x6 T* @3 C! o, }/ pDevelopment ....................................................................................... 263' V( F# L7 Q: W, R7 z$ R
Parts 862 to 1050................................................................................... 264/ H7 q% m) C G- l
Abbreviations.............................................................................................. 2657 q) e4 B6 W. f6 i
International and National Standard Abbreviations............................ 265/ S& z+ `) Q8 E5 P( j
Regulatory Abbreviations ...................................................................... 265 |
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