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Introduction................................................................................................ 225- e# N8 m) n' N" ?6 f0 |& b1 n
Regulatory Requirements Are Enforced by Law................................. 225( y) _! _! X9 x5 d* |
Make Regulatory Affairs Cost-Effective................................................ 225 |3 G( ?5 D4 x; }: N) b7 M$ G
Regulatory Requirements Improve Device Safety and2 W; B/ w% O) C
Effectiveness ........................................................................................ 2256 q! W6 d3 \ |( y5 H
Regulatory Affairs Requires Good Judgment ...................................... 2266 V" I: A. ]" Y" J: m1 z, S2 [1 V0 O
FDA Overview and Authority................................................................... 226
: i& r/ J9 O: r* HImportant FDA Jurisdiction Acts, History, and Assistance................. 227
~$ s8 @$ Q* q# C' l6 xOnline Assistance .................................................................................. 2272 G: H K m) S- t8 q# L
The Basics: Short Discussion of Establishment Registration,
( S9 h0 x7 \) K* E7 p5 h# H3 kDevice Submissions, Device Listing, and Device
% Y5 Z( Z- x3 m+ `- Z6 @Classification............................................................................................. 228$ j( t* U8 l1 W& B1 @
Establishment Registration .................................................................... 228
% t$ M2 F0 X$ \% S7 wDevice Listing ........................................................................................ 228
9 X% m: B/ J+ \: B2 ODevice Classification ............................................................................. 229
: U1 m! C0 v8 t" G1 s5 y" DDevice Functional Classification........................................................... 230
/ P. l$ D- x4 I' y510(k) Premarket Notification .............................................................. 230- n- D8 P5 Q3 I( D' E4 @' G: u
Substantial Equivalence......................................................................... 2315 a0 s6 d) d) @6 q
Premarket Approval Submission .......................................................... 232
3 B* R y7 h) P4 KInvestigational Device Exemption and Supporting Studies ............... 2323 E4 ~1 d0 t1 n/ w! O
Third-Party Submission Review by Accredited Parties....................... 233) j/ G0 @. n/ |1 }0 X4 T
Importing into the U.S.......................................................................... 234
( W0 p9 _# `6 p" t& \- c& M6 C, D9 rInitial Importers................................................................................. 234: o% I) ], r- s1 O: `3 M$ r3 L8 [9 y
Exporting Devices ................................................................................. 234# z5 S# A" w, @9 J* n9 m' S
Certificates for Foreign Government............................................... 235. m% C0 N( j, S0 o$ ?/ G& w
Additional Regulations by Different States.......................................... 235
1 R' P3 l, X I# e kSpecial Considerations............................................................................... 236
7 a5 V0 g! x- HExemptions from 510(k) and GMP Requirements.............................. 236
2 M% N) F# {' u( h; x; ^, C- uClass I Devices .................................................................................. 236
1 P9 R( O* B2 n7 b# J/ e9 }Class II Devices................................................................................. 236
" Y& G. X( d* L9 S$ s/ B; G- ISpecial 510(k) ........................................................................................ 237
& l9 v& k+ C+ cAbbreviated 510(k)................................................................................ 2383 L, r! f, e9 j8 V) p$ i# u; w
De Novo
! M8 L1 c: a! @- C$ F- e+ Y \6 ^.................................................................................................. 238
) t5 j3 e/ S/ x) \% v' mProduct Development Protocol............................................................ 2391 o- M- d! [9 E! h7 p. _
Humanitarian Use Device/Humanitarian Device Exemption............. 239/ H4 i8 a N, {3 v
Good Quality and Procedural Practices .................................................. 240
' {1 d1 c+ m* `) A. e) B) AQuality System Regulations (QSR)....................................................... 240
+ b7 |: n5 ]! cQuality System Inspection Technique (QSIT)..................................... 241
. } }2 Q( I i1 S( ~) k- O- o3 c' h' zGood Clinical Practice .......................................................................... 241* m/ X( N; r. G4 K2 z2 E- N2 x( \8 k
Good Laboratory Practices ................................................................... 242
" C7 R0 s+ C5 ~7 URegulations ........................................................................................ 242
2 C( a+ i, c* W sPreclinical Studies.................................................................................. 242
4 d, u' n7 p& W7 u5 }" H9 oSummary of Title 21 of the Code of Federal Regulations,
6 s/ w# O4 v* E Z" T* p% JParts 800 to 1299, for Medical Devices ................................................. 243
/ w5 _) V& b. E8 m4 w* U& hPart 800: General Requirements........................................................... 243
* S; w5 S( T( G3 W0 { _+ q4 I% EPart 801: Labeling.................................................................................. 243
( z5 ?, |) Z( A, k% r6 L9 l# s6 d0 BPart 803: Medical Device Reporting (MDR)........................................ 244: z7 z& p. s0 X/ r
Part 806: Medical Devices: Reports of Corrections
$ u/ L; p. [9 w: Xand Removals ...................................................................................... 246( c6 _) R# Q9 G; Y. B1 U. N
Part 807: Establishment Registration and Device Listing for7 [. [1 {' @$ ~: F. s9 ]
Manufacturer and Individual Importers of Devices ......................... 246+ d H8 m/ O( g; w! ]1 M& H( k. ~
Part 808: Exemptions from Federal Preemption of State and; @# g: H; s( ^7 V. A! v
Local Medical Device Requirements .................................................. 248# y, Y% G! K5 f. ?2 T, c
Part 809:
F# A$ A- l u( ]In Vitro, m! e6 l/ f: r: b% b
Diagnostic Products for Human Use .................... 248
2 v$ U4 E( Y/ Z1 z7 W- i6 X) r0 nPart 810: Medical Device Recall Authority.......................................... 249
# l; Y* K) ?/ L gPart 812: Investigational Device Exemptions...................................... 250+ U' e1 X* d1 C: _1 W, p$ g/ f
Part 820: Quality System Regulation.................................................... 257: S7 s6 }, | ]/ b
Part 821: Medical Device Tracking Requirements .............................. 259
0 I' U9 z, b7 ?5 l" aPart 822: Postmarket Surveillance ........................................................ 261/ v% [8 l, N; `7 w( a( I- L% \
Part 860: Medical Device Classification Procedures ........................... 262
3 X& Y/ W) W- w& s, v) q! fPart 861: Procedures for Performance Standards- Y1 `, i7 |5 S- d* ?! C
Development ....................................................................................... 2638 v3 ?' H0 _! \/ a" c2 s
Parts 862 to 1050................................................................................... 264
7 \, q9 [! t: |Abbreviations.............................................................................................. 265- a( X7 y/ z: {. E1 d0 Z
International and National Standard Abbreviations............................ 265
; T' t! M G( ?! RRegulatory Abbreviations ...................................................................... 265 |
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