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Introduction................................................................................................ 225( Y3 } ~2 ]) f `: I
Regulatory Requirements Are Enforced by Law................................. 225
; M+ x& W0 Q3 Q; C& I7 o' mMake Regulatory Affairs Cost-Effective................................................ 225- }$ Q+ g+ @6 p+ B
Regulatory Requirements Improve Device Safety and
' K' a; m, F& w, q2 tEffectiveness ........................................................................................ 225
( ^& q8 ]5 |' \& U5 aRegulatory Affairs Requires Good Judgment ...................................... 226
. X4 k, z3 Z# E1 ]# O- ^0 L; AFDA Overview and Authority................................................................... 226
: N( Q3 K+ u/ d, XImportant FDA Jurisdiction Acts, History, and Assistance................. 227
. H+ r g( L' }* tOnline Assistance .................................................................................. 2276 r, E0 V) m8 j0 U0 F0 p
The Basics: Short Discussion of Establishment Registration,! r/ N2 V- N8 v9 n# ?/ k
Device Submissions, Device Listing, and Device; C7 W* Z& K0 l5 |3 i. f/ ]
Classification............................................................................................. 2288 Q. w2 R( R6 i/ n5 R/ ~+ P
Establishment Registration .................................................................... 228; x7 p8 I# V5 z. a
Device Listing ........................................................................................ 2281 o5 h8 F: p/ m% J& [
Device Classification ............................................................................. 2293 [9 f7 b- b; Q3 S6 N G9 C m
Device Functional Classification........................................................... 230% ?- u; l* O* ~' I2 p& l
510(k) Premarket Notification .............................................................. 230
/ f' ], R" D% R' I% t( U: [Substantial Equivalence......................................................................... 231
9 G% h: `0 @ K. ~8 J( X3 BPremarket Approval Submission .......................................................... 232
+ [6 o4 G I! y b+ g1 HInvestigational Device Exemption and Supporting Studies ............... 232
% M! _+ q( W b& h4 X: QThird-Party Submission Review by Accredited Parties....................... 233# [& X- D3 p7 ]3 ~1 y; G# Z
Importing into the U.S.......................................................................... 234( ?2 _' s+ Q' \
Initial Importers................................................................................. 234, g2 o% K. s! f6 r4 C
Exporting Devices ................................................................................. 234
4 B: Y' i! T0 G( XCertificates for Foreign Government............................................... 235
/ _+ _# [5 R3 }. g1 R. C& wAdditional Regulations by Different States.......................................... 235
3 ?' w+ E* c8 y* z7 sSpecial Considerations............................................................................... 236! z( E- A4 L8 A
Exemptions from 510(k) and GMP Requirements.............................. 236
/ s2 m+ |2 }4 Y0 p+ PClass I Devices .................................................................................. 236
$ S7 K# v6 h# n) n7 O, B. LClass II Devices................................................................................. 236* r* W0 T. H) Y
Special 510(k) ........................................................................................ 237( r' P5 X! ~1 c" j5 f2 o
Abbreviated 510(k)................................................................................ 238. N, x8 M' I1 I+ d3 X7 S
De Novo
- p; P5 L3 n7 O( m; b.................................................................................................. 238+ U5 J2 O+ }! v2 `
Product Development Protocol............................................................ 239
% A- Y m( [& z4 eHumanitarian Use Device/Humanitarian Device Exemption............. 2391 s0 {) W8 Q8 q
Good Quality and Procedural Practices .................................................. 240
; r) Z2 v) e2 t- GQuality System Regulations (QSR)....................................................... 240, p( @: X: \- i9 X
Quality System Inspection Technique (QSIT)..................................... 241
( t$ \' O0 |- i5 @8 K3 [Good Clinical Practice .......................................................................... 241
7 b l: X- D4 \0 m- NGood Laboratory Practices ................................................................... 242
% @# ~/ g: z! eRegulations ........................................................................................ 2428 s# d {5 B. R7 [* h
Preclinical Studies.................................................................................. 242
4 o2 {1 {6 P& y; _+ [& wSummary of Title 21 of the Code of Federal Regulations,1 {( b4 _( d9 K# l" A0 C
Parts 800 to 1299, for Medical Devices ................................................. 243& \. G" [% x/ q. z7 c- r: L. \/ B
Part 800: General Requirements........................................................... 243
- |' I( g1 h: h6 tPart 801: Labeling.................................................................................. 243" D8 ^/ ~; N; S$ W
Part 803: Medical Device Reporting (MDR)........................................ 244; @8 Y' _8 I7 y+ |8 v
Part 806: Medical Devices: Reports of Corrections( V( _: n, s+ x# p) F
and Removals ...................................................................................... 246" w: i1 ^; a8 A( t' i1 e
Part 807: Establishment Registration and Device Listing for6 A0 \+ o% v9 ^* N; e |
Manufacturer and Individual Importers of Devices ......................... 246
/ P2 m9 T" T3 n; M2 yPart 808: Exemptions from Federal Preemption of State and
* {. n: _6 e: q; F( l+ y/ G* I& tLocal Medical Device Requirements .................................................. 2489 I0 D7 y Y5 W; D
Part 809:" n4 D1 p1 `3 g: Y! T
In Vitro0 F$ s' ]0 `8 y) H- D9 C
Diagnostic Products for Human Use .................... 248: M3 X. d, K. u! m
Part 810: Medical Device Recall Authority.......................................... 249
2 i5 K& A8 L: @- u6 i# ?3 [, O* }Part 812: Investigational Device Exemptions...................................... 250
. k6 C2 m4 ]( y5 t2 z# D: xPart 820: Quality System Regulation.................................................... 257
% B. r! @: b/ O- P$ v6 OPart 821: Medical Device Tracking Requirements .............................. 2599 S( ]9 x4 w0 K1 D& ~
Part 822: Postmarket Surveillance ........................................................ 261& J @+ r. ^6 W5 t
Part 860: Medical Device Classification Procedures ........................... 262
. \! C: d* g, Y) f. q8 TPart 861: Procedures for Performance Standards! U0 v* n- J7 F; X7 z' i
Development ....................................................................................... 263
$ J8 M: I, ?% i* T) }9 u; GParts 862 to 1050................................................................................... 264
$ b+ m; u2 e4 [1 TAbbreviations.............................................................................................. 265; g: E8 t( P' u ^; _5 N
International and National Standard Abbreviations............................ 265: | ~7 d: F. J/ p3 T) |. X
Regulatory Abbreviations ...................................................................... 265 |
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