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Introduction................................................................................................ 225' x+ _( m" Q/ i$ T s$ }0 [0 v0 G
Regulatory Requirements Are Enforced by Law................................. 225+ O0 k4 \$ h! Q! f# E- s5 ]# L
Make Regulatory Affairs Cost-Effective................................................ 225- Q# s' E* X! J: M, V/ l7 b
Regulatory Requirements Improve Device Safety and
; _1 H% m3 n* w1 ]* E( vEffectiveness ........................................................................................ 225* Z- v! I! g: n k
Regulatory Affairs Requires Good Judgment ...................................... 226+ ^/ Q- d ~* |/ s) F5 n6 y
FDA Overview and Authority................................................................... 226
8 G% P( n& |( S; }1 d5 n. w$ nImportant FDA Jurisdiction Acts, History, and Assistance................. 227; h; D2 u: q. R& h) W
Online Assistance .................................................................................. 227
% x! ?- @3 L. G) x6 w! LThe Basics: Short Discussion of Establishment Registration,
! g/ Z% a) O3 K% }7 S( [Device Submissions, Device Listing, and Device0 K1 m. l. m( Z4 p5 ], e+ D
Classification............................................................................................. 228# T' o* |$ g) `& V+ R
Establishment Registration .................................................................... 228
0 ?$ U$ f k( o9 S, }& Z# zDevice Listing ........................................................................................ 228& O1 L( e' K' ~! T) \
Device Classification ............................................................................. 229
$ u \/ E" R6 D1 kDevice Functional Classification........................................................... 230& t. t5 Z8 f: B; _9 y! {+ T/ t% ~5 ]0 U+ |
510(k) Premarket Notification .............................................................. 230& [& z0 O- y4 K3 _
Substantial Equivalence......................................................................... 231- s0 ?) s' ~" _, v
Premarket Approval Submission .......................................................... 232; n$ f) {4 R! f/ ~0 f+ ~/ e8 H! W
Investigational Device Exemption and Supporting Studies ............... 232 z8 N2 T2 t6 S ?5 W5 g$ S" p' T
Third-Party Submission Review by Accredited Parties....................... 233
* u: |- H& D. E* _7 y- ~% n. xImporting into the U.S.......................................................................... 234) G1 t' k# i* i2 Q: V n1 K5 L
Initial Importers................................................................................. 234
/ d* W( F. ]( n+ JExporting Devices ................................................................................. 234
: o0 T1 w- B8 WCertificates for Foreign Government............................................... 235
$ F) U1 n- e1 {- TAdditional Regulations by Different States.......................................... 235
2 j; e& a* K9 w8 hSpecial Considerations............................................................................... 236
. s: X n% J0 F$ `$ J5 ^Exemptions from 510(k) and GMP Requirements.............................. 2369 d8 p, g- M" P& }0 e
Class I Devices .................................................................................. 236
8 d3 n7 `* ^5 \5 b; p$ wClass II Devices................................................................................. 2365 n9 ^; X7 F' u! b8 z8 ]
Special 510(k) ........................................................................................ 237
& M" `: ~% T8 X3 k1 TAbbreviated 510(k)................................................................................ 238
) [2 ?9 J. s. B# t7 {/ h* KDe Novo
" I5 ]& J X( i. R Z. Q% ^.................................................................................................. 238
% `" w4 X( w9 T* nProduct Development Protocol............................................................ 2399 A1 B1 G) e" v
Humanitarian Use Device/Humanitarian Device Exemption............. 239
6 [1 p$ b) ^1 K; z9 {$ |Good Quality and Procedural Practices .................................................. 2400 r( S& h$ H% X' W) Z, P$ [% t
Quality System Regulations (QSR)....................................................... 240
3 u9 Y& m% m4 O! {8 AQuality System Inspection Technique (QSIT)..................................... 241
9 w8 Y4 g" N4 m/ r3 |0 {Good Clinical Practice .......................................................................... 241
$ _( f8 S o( s6 h* a; ZGood Laboratory Practices ................................................................... 2422 K8 g0 D4 F- r3 `$ ~! k7 _! l
Regulations ........................................................................................ 242) _4 \4 {0 R$ O
Preclinical Studies.................................................................................. 2423 o/ f- j6 s# f* ?" I5 {; M
Summary of Title 21 of the Code of Federal Regulations,: O: p; k# a8 T& g+ o& h5 t
Parts 800 to 1299, for Medical Devices ................................................. 243' T5 ~$ Q% a7 R9 @" @ u
Part 800: General Requirements........................................................... 243/ C$ Z3 h: \7 c, ~4 u" x3 e
Part 801: Labeling.................................................................................. 2430 g# V4 t* y5 S& X
Part 803: Medical Device Reporting (MDR)........................................ 244
, q7 @& z; ?7 RPart 806: Medical Devices: Reports of Corrections _6 `; a3 P) J' g
and Removals ...................................................................................... 246
& D. L% U( ]" SPart 807: Establishment Registration and Device Listing for& d- h" W) F+ O3 K" }
Manufacturer and Individual Importers of Devices ......................... 246
5 ?$ @- N& ~& NPart 808: Exemptions from Federal Preemption of State and
1 G: {9 L5 X, ~* S zLocal Medical Device Requirements .................................................. 248; @- @9 U0 T3 L% N1 Z
Part 809:9 J+ H$ b9 l6 S# P, H5 v5 P
In Vitro* d2 \5 F, s. n
Diagnostic Products for Human Use .................... 248
# D) O# V6 c# Y fPart 810: Medical Device Recall Authority.......................................... 249
4 c" w* D4 H, J% IPart 812: Investigational Device Exemptions...................................... 250
& ~) W* _9 i) ?' S; E3 YPart 820: Quality System Regulation.................................................... 257
0 p! w+ S( i$ B+ B& \$ d7 E6 OPart 821: Medical Device Tracking Requirements .............................. 259: B x3 F' o0 R' p% Q, v T( g
Part 822: Postmarket Surveillance ........................................................ 261) ]" C5 q g m
Part 860: Medical Device Classification Procedures ........................... 2629 [3 w+ X Z* ]( s
Part 861: Procedures for Performance Standards
, U' B+ {: l8 m3 Q8 ZDevelopment ....................................................................................... 263
* o# B7 \! q7 `Parts 862 to 1050................................................................................... 264
k9 o4 x. U) A- y2 DAbbreviations.............................................................................................. 265
+ l$ a+ N; C9 I* ~% ZInternational and National Standard Abbreviations............................ 265
- {! h$ H" ~" oRegulatory Abbreviations ...................................................................... 265 |
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