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标题: REGULATORY AFFAIRS: MEDICAL DEVICES [打印本页]
作者: oguz    时间: 2009-11-15 23:40
标题: REGULATORY AFFAIRS: MEDICAL DEVICES
Introduction................................................................................................ 225
1 f1 a" E0 k4 W/ }& ORegulatory Requirements Are Enforced by Law................................. 2250 L9 r/ [& }: ^1 C* o8 {3 q% p, b
Make Regulatory Affairs Cost-Effective................................................ 2250 |/ t& `" v, F+ ~
Regulatory Requirements Improve Device Safety and: ~; s( C; t9 p. g9 m: N: s. L) ]
Effectiveness ........................................................................................ 225# p* q, C! m7 K. C2 d1 w) t
Regulatory Affairs Requires Good Judgment ...................................... 226
3 q+ n( Q2 N7 R, o% X  w0 U$ ?! @FDA Overview and Authority................................................................... 226" G8 W0 ?8 [. `7 c/ n
Important FDA Jurisdiction Acts, History, and Assistance................. 227( M2 Z$ u+ m; F1 h
Online Assistance .................................................................................. 227
  c- `" v8 h& U( f9 l5 cThe Basics: Short Discussion of Establishment Registration,3 w% T5 u8 p$ K2 b3 z
Device Submissions, Device Listing, and Device6 [% ]; D; A5 h/ O% A7 F8 l* |& Y
Classification............................................................................................. 228
! g- c* b4 Q9 J+ N2 Q* HEstablishment Registration .................................................................... 2282 G) }7 j. c. y/ u, t3 }8 H, j
Device Listing ........................................................................................ 228
% @  s0 W4 d" @# F# wDevice Classification ............................................................................. 229
) w( P$ U; z: ADevice Functional Classification........................................................... 230& m- o8 s5 d4 J4 X4 H; F: C
510(k) Premarket Notification .............................................................. 230* u% a( s& L0 s9 d% x
Substantial Equivalence......................................................................... 231
$ M7 v# O6 u+ b% bPremarket Approval Submission .......................................................... 232
2 H, P. ^- R1 s4 |Investigational Device Exemption and Supporting Studies ............... 232
+ ?( A# @; w4 F/ o/ \" S# T6 I# _Third-Party Submission Review by Accredited Parties....................... 233
5 z( n9 G) {" x1 j) M" F0 ?0 IImporting into the U.S.......................................................................... 234( R# S5 S* b3 b' H7 j# t
Initial Importers................................................................................. 234
( {  r* F  z5 YExporting Devices ................................................................................. 234
9 A7 B- S# j, z( W1 n* o- p% vCertificates for Foreign Government............................................... 235
# {' H" J0 ]8 {  P4 \Additional Regulations by Different States.......................................... 2354 C& N, K  [( `( w4 S( S
Special Considerations............................................................................... 236, U+ k5 I: }* o# u0 Y. _
Exemptions from 510(k) and GMP Requirements.............................. 236% s1 W  r( W0 h9 d$ w: q0 k
Class I Devices .................................................................................. 236
: V' _6 ^3 H. S# L, b7 u; k" IClass II Devices................................................................................. 236- B9 S/ |- I' K, ~
Special 510(k) ........................................................................................ 237
7 R( L2 H9 o$ i5 \, O3 `/ i3 yAbbreviated 510(k)................................................................................ 238/ t% a6 ~+ j/ I. Z: d/ `
De Novo
; ]3 P8 E" V; I) d/ Z, t.................................................................................................. 238/ H" R& I9 Z. v' Q, N! B
Product Development Protocol............................................................ 239
/ A3 h1 E' Y, BHumanitarian Use Device/Humanitarian Device Exemption............. 239
$ t) h4 U3 V+ e$ X+ x0 \8 E: Z$ s1 OGood Quality and Procedural Practices .................................................. 240$ i: s; R. I  H8 f
Quality System Regulations (QSR)....................................................... 240
( `0 V8 m4 b/ X" P, g- nQuality System Inspection Technique (QSIT)..................................... 241. M5 U4 R1 Z! \5 \! x. F
Good Clinical Practice .......................................................................... 241/ L5 Z! |1 |2 w5 N* U
Good Laboratory Practices ................................................................... 242
" a4 V% H$ t5 M; W5 H* M; ]1 {Regulations ........................................................................................ 242
6 c% A. z  K$ X2 IPreclinical Studies.................................................................................. 242
; {& g( n; H$ q; ZSummary of Title 21 of the Code of Federal Regulations,' X, v2 P! V! v5 k4 c& r# ~
Parts 800 to 1299, for Medical Devices ................................................. 243
, r9 T3 c  x# |; {1 p, F+ \Part 800: General Requirements........................................................... 243
! B+ H7 A" s& z1 }, w+ N' dPart 801: Labeling.................................................................................. 243
( ?5 a" U! \& j$ hPart 803: Medical Device Reporting (MDR)........................................ 244
+ s7 Q* h$ i4 n+ I( lPart 806: Medical Devices: Reports of Corrections# z; G: t/ z& }/ }: |" `
and Removals ...................................................................................... 246
4 T  a+ b# F5 }1 MPart 807: Establishment Registration and Device Listing for1 d! A0 x& ~6 U, O
Manufacturer and Individual Importers of Devices ......................... 246' J; C& v5 o8 I1 X! L+ `
Part 808: Exemptions from Federal Preemption of State and
& e) h. t& J$ L6 a1 zLocal Medical Device Requirements .................................................. 2487 ]5 ^7 c  O" {' a- T7 ^6 n
Part 809:# r7 j8 B: {! z
In Vitro
! b- v& |; h; W$ ^, E5 u2 bDiagnostic Products for Human Use .................... 248" t2 a  s0 }2 Q. m& N& O: x5 r9 X
Part 810: Medical Device Recall Authority.......................................... 249" \, V4 t' x, C# C3 ]% M
Part 812: Investigational Device Exemptions...................................... 250
3 c+ h. i* p. X8 t: rPart 820: Quality System Regulation.................................................... 257
: g* {& C  }4 |  x8 ^+ x3 t# h. uPart 821: Medical Device Tracking Requirements .............................. 259
* _% |- z/ C% V* l2 c4 RPart 822: Postmarket Surveillance ........................................................ 2613 g' Y. ^7 h9 \6 {( S6 k, x. W  q
Part 860: Medical Device Classification Procedures ........................... 262
9 Y/ ]5 H7 ?, H, \9 H+ h4 \& HPart 861: Procedures for Performance Standards) }- [' X4 p+ _% f, i; B
Development ....................................................................................... 263# W; t* _% H4 A  t7 J; b
Parts 862 to 1050................................................................................... 264
' a5 b3 ^8 C0 V5 _- ~Abbreviations.............................................................................................. 265
2 }7 w  ^, F0 W: uInternational and National Standard Abbreviations............................ 265
) y  Y( Z( }4 \0 i  S3 ]: mRegulatory Abbreviations ...................................................................... 265



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