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Introduction................................................................................................ 225
' ?3 j9 u3 B+ ORegulatory Requirements Are Enforced by Law................................. 2253 y, T8 a$ i5 j- v. e' \
Make Regulatory Affairs Cost-Effective................................................ 225# V: w3 |% O' W
Regulatory Requirements Improve Device Safety and. W \7 m9 }2 p
Effectiveness ........................................................................................ 225
5 h. K- [' h7 y: tRegulatory Affairs Requires Good Judgment ...................................... 2263 W; T- ~; T% V; h6 ]( \
FDA Overview and Authority................................................................... 226
# K6 @) ~' o' H6 y: j; [1 kImportant FDA Jurisdiction Acts, History, and Assistance................. 2277 K; g+ M. ]* r; h& Y, o
Online Assistance .................................................................................. 227: C( D4 i) s4 u3 K' x. A t' z
The Basics: Short Discussion of Establishment Registration,
* |% q4 o6 _( {; x5 {0 T5 BDevice Submissions, Device Listing, and Device
. I% m+ l2 }, l* C! RClassification............................................................................................. 2285 O2 X/ z; c8 i9 E( {, F7 N4 q. ]
Establishment Registration .................................................................... 228$ N6 v3 j; i' T* _* s! m
Device Listing ........................................................................................ 228
6 m; o% L* y6 w$ U7 EDevice Classification ............................................................................. 229
$ y) b0 n0 o9 E) S) G+ [Device Functional Classification........................................................... 230; g8 @' P6 l( G; G+ ~5 J
510(k) Premarket Notification .............................................................. 230& W+ w! r) \8 N6 [( b. f
Substantial Equivalence......................................................................... 231
2 a* h% s9 G. \; oPremarket Approval Submission .......................................................... 232
9 t7 }1 a# T b k) V# CInvestigational Device Exemption and Supporting Studies ............... 232
* c5 M, S6 r o" SThird-Party Submission Review by Accredited Parties....................... 233
# e/ N; s6 }* k, |; }Importing into the U.S.......................................................................... 234 [& G+ T" x/ l% V
Initial Importers................................................................................. 234+ b, k- h* R. ~7 Y$ H
Exporting Devices ................................................................................. 2341 s% {1 b& S g+ d3 n5 o
Certificates for Foreign Government............................................... 235' P" D) l H' d; u
Additional Regulations by Different States.......................................... 2356 S* j3 O& S: o& n
Special Considerations............................................................................... 2361 v; M' V2 D* a) h8 v8 {' U4 G3 K
Exemptions from 510(k) and GMP Requirements.............................. 236/ U. e2 A e/ k0 ~" ?
Class I Devices .................................................................................. 236
: u' a8 J# r, A2 Q% d/ X/ u2 y8 uClass II Devices................................................................................. 236! x/ `' I/ d2 Q( R! Q8 l
Special 510(k) ........................................................................................ 237# E& s3 q. ?" S V' i% Q, S
Abbreviated 510(k)................................................................................ 238 r% P. r2 @- \4 Q0 a* \
De Novo6 h; R4 O# t4 M y. n& E' q' {* p
.................................................................................................. 2383 [1 G3 o5 P E" v5 F* o! C) P
Product Development Protocol............................................................ 239
; f3 y" C/ A' C2 d- j: ^0 [1 dHumanitarian Use Device/Humanitarian Device Exemption............. 239$ x% z& u+ |' F
Good Quality and Procedural Practices .................................................. 240* v) u" j& B. n1 }6 T
Quality System Regulations (QSR)....................................................... 2402 U1 V8 ~( f2 F" i0 x8 _$ n+ ]
Quality System Inspection Technique (QSIT)..................................... 241
' `7 D: T: U; {# m2 jGood Clinical Practice .......................................................................... 241; U. Y. a# c. |9 x
Good Laboratory Practices ................................................................... 242* N( b# q$ J/ K; Y
Regulations ........................................................................................ 242
+ n: \" v1 `6 ePreclinical Studies.................................................................................. 242
7 Z% T! J+ w$ I! @0 \: GSummary of Title 21 of the Code of Federal Regulations,
) L5 Q' Z/ j7 A& s$ P4 `/ uParts 800 to 1299, for Medical Devices ................................................. 243
8 ~& ]" F& `& D7 A4 Y/ V. f1 Q7 y$ aPart 800: General Requirements........................................................... 2434 t) J4 j! @9 f* n4 J
Part 801: Labeling.................................................................................. 243# ` G7 Y: _ Z5 h0 N/ Y0 C' ]2 w3 [
Part 803: Medical Device Reporting (MDR)........................................ 244* g) ^; s) R3 X. g6 l" O8 z) F
Part 806: Medical Devices: Reports of Corrections
; f0 S) `' j2 e' [3 D2 vand Removals ...................................................................................... 246
# ?( }8 w3 j$ U7 O9 e% K VPart 807: Establishment Registration and Device Listing for
! t1 ?. y! J. U& Q. m1 ~+ G. DManufacturer and Individual Importers of Devices ......................... 246
* @( t( a: f8 p; Z0 q! e! x+ _! jPart 808: Exemptions from Federal Preemption of State and
% E0 M, I/ V k \% R' }% iLocal Medical Device Requirements .................................................. 248
: h( _! j4 d/ }# A) SPart 809:
6 B. I) M5 @/ L0 U, M# yIn Vitro$ Y: t- d/ O7 | C% [* A
Diagnostic Products for Human Use .................... 248
* K$ T* X p2 r3 M0 T1 K$ PPart 810: Medical Device Recall Authority.......................................... 249/ ~) N" x0 Z2 @# j- ~9 t" p
Part 812: Investigational Device Exemptions...................................... 250
4 y: u# ]. N: P( @$ F% b$ f4 XPart 820: Quality System Regulation.................................................... 257
9 e' A* S3 @& DPart 821: Medical Device Tracking Requirements .............................. 259
% h$ y2 Y4 w6 j1 s2 H4 pPart 822: Postmarket Surveillance ........................................................ 2615 ^/ i5 J% A/ x& b
Part 860: Medical Device Classification Procedures ........................... 262$ a! B* T) y" i
Part 861: Procedures for Performance Standards
2 l/ |- p& r0 `; q" FDevelopment ....................................................................................... 263
1 ?0 ^. _8 e! C$ g2 V4 p& YParts 862 to 1050................................................................................... 264* I( c& L% ?, v a, m
Abbreviations.............................................................................................. 265
! ^# Q5 v f& \$ f6 `% aInternational and National Standard Abbreviations............................ 265
6 n: |4 n" m* |% {' ~+ c* p V3 m$ KRegulatory Abbreviations ...................................................................... 265 |
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