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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! g) d$ X" k0 O7 d
Regulatory Requirements Are Enforced by Law................................. 225
! l# [: X" r% |Make Regulatory Affairs Cost-Effective................................................ 2251 d; }+ M* D' \6 C/ J
Regulatory Requirements Improve Device Safety and
5 o. Z% L/ f+ }  oEffectiveness ........................................................................................ 225$ H4 {9 W$ p, V" o! G9 |) v6 o0 @" P* J
Regulatory Affairs Requires Good Judgment ...................................... 226- V- Q( u" E# g& }* K! i! x/ a
FDA Overview and Authority................................................................... 226; G$ S$ x2 r/ L7 P- d
Important FDA Jurisdiction Acts, History, and Assistance................. 227
( o+ t) t1 F8 |) w: Y; i9 yOnline Assistance .................................................................................. 227
% p* `' v* e. g7 x  I% B  \4 ]/ lThe Basics: Short Discussion of Establishment Registration,% z( }4 ?+ k7 _3 h0 P
Device Submissions, Device Listing, and Device
- |/ J* g3 M$ S4 B( ~- IClassification............................................................................................. 2284 }4 r1 o+ M+ I
Establishment Registration .................................................................... 228
) |" \- s$ n! ]3 [Device Listing ........................................................................................ 228
2 b( j% M* X4 c( t: \$ cDevice Classification ............................................................................. 229+ o0 q& z5 g1 z/ b0 y
Device Functional Classification........................................................... 230
) e2 P+ e6 x% J5 g; ~1 D1 N510(k) Premarket Notification .............................................................. 230
8 z" h6 w% M5 \( ^; TSubstantial Equivalence......................................................................... 231  J2 s) j' t3 E& E* M4 Q9 g9 g
Premarket Approval Submission .......................................................... 232
1 e# `+ q8 c3 XInvestigational Device Exemption and Supporting Studies ............... 2324 A# x4 s- _  Y  X' W% B" j
Third-Party Submission Review by Accredited Parties....................... 233
5 r# Q3 ]2 E5 n$ b1 aImporting into the U.S.......................................................................... 234
* j$ U% ]* ^9 d8 YInitial Importers................................................................................. 234& |' }# V( |8 x& A) V
Exporting Devices ................................................................................. 234
! j/ j/ `8 ^0 E) f, c* g- OCertificates for Foreign Government............................................... 235
/ y- ?1 F- Y- D1 |Additional Regulations by Different States.......................................... 2352 q6 N- C% m+ N
Special Considerations............................................................................... 236' D% B- q! Z* I% [% E- x4 L0 I1 y$ I
Exemptions from 510(k) and GMP Requirements.............................. 2361 J& s+ N' e/ M# ~( ^6 W) P1 ^: P
Class I Devices .................................................................................. 2362 s: q# u7 ^$ b* G; q3 v" I
Class II Devices................................................................................. 2363 Z% Y: h" r. c% v' r
Special 510(k) ........................................................................................ 237
( x3 r. q# o$ Y: ?8 vAbbreviated 510(k)................................................................................ 238: E! H$ ^1 [% L
De Novo8 b3 H4 j' Z8 l# {
.................................................................................................. 238' s6 C/ p& W7 o4 q5 e. D) f7 K( \
Product Development Protocol............................................................ 239$ o  ~$ J1 j8 S" W. ]
Humanitarian Use Device/Humanitarian Device Exemption............. 239
# Q1 `; ?+ Z* BGood Quality and Procedural Practices .................................................. 2403 R2 g3 i* t+ |! W0 s( i& c
Quality System Regulations (QSR)....................................................... 240
5 [$ T! V  I5 ?: ?' D2 T4 lQuality System Inspection Technique (QSIT)..................................... 241( D) d$ Q7 Q, i7 y% m2 q' M
Good Clinical Practice .......................................................................... 241) |% u2 \; x3 \6 M/ ^
Good Laboratory Practices ................................................................... 242  q8 h/ t. I: I1 Q7 m% G) [
Regulations ........................................................................................ 242; A' u0 T/ `7 Z. X3 q7 A* {
Preclinical Studies.................................................................................. 242
4 V, F) o" W' LSummary of Title 21 of the Code of Federal Regulations,
. J  w+ M$ z% l3 I7 }6 O; PParts 800 to 1299, for Medical Devices ................................................. 2432 p$ I; ?) O4 W) Q- R5 r6 q
Part 800: General Requirements........................................................... 2437 |, ]4 }# V: J. l. L% M
Part 801: Labeling.................................................................................. 243) S' N8 e; u8 x- O  o' F  Q+ R0 S
Part 803: Medical Device Reporting (MDR)........................................ 244
+ D) f2 z; u7 e, LPart 806: Medical Devices: Reports of Corrections5 c" G$ e$ l9 A7 R2 u( w
and Removals ...................................................................................... 246# B* I# j1 t& ?( Y9 b
Part 807: Establishment Registration and Device Listing for0 ]6 r* ]% O- y8 P! w# ]' k, {
Manufacturer and Individual Importers of Devices ......................... 246
5 x; S" c0 P) c1 e# HPart 808: Exemptions from Federal Preemption of State and
6 a, w& E! w0 k( LLocal Medical Device Requirements .................................................. 248
, Q' S; w: [% {! d4 |6 t8 k5 K6 l( z, jPart 809:6 T: \1 L, d9 c" f
In Vitro" Y' q/ R$ b2 z# ]* `. `
Diagnostic Products for Human Use .................... 2488 N' h9 y! e/ H" Y* P  M
Part 810: Medical Device Recall Authority.......................................... 2490 e2 Y( ^( @0 C( I
Part 812: Investigational Device Exemptions...................................... 250! Z2 j. U! {0 M+ G2 Z. O5 ^! a$ F
Part 820: Quality System Regulation.................................................... 257' W6 V0 R+ N4 J* I1 {) m6 w
Part 821: Medical Device Tracking Requirements .............................. 259/ F' ^& D: h/ E% S
Part 822: Postmarket Surveillance ........................................................ 261
4 D. H1 {6 t( T: iPart 860: Medical Device Classification Procedures ........................... 262
% q# N+ v' ~+ K0 |) o& }% VPart 861: Procedures for Performance Standards2 c$ [) ]$ y4 ]6 U& e, I
Development ....................................................................................... 263
( J/ ~; Y- p, AParts 862 to 1050................................................................................... 2648 \7 U6 {* V$ ^; m
Abbreviations.............................................................................................. 265
6 A- s6 p" M* U: L3 C" A- _7 f4 aInternational and National Standard Abbreviations............................ 265" F  }0 @- y: {$ L
Regulatory Abbreviations ...................................................................... 265



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