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Introduction................................................................................................ 225$ J, s, O% d& a& d
Regulatory Requirements Are Enforced by Law................................. 225
; t( x- j; W3 W, O: M* ZMake Regulatory Affairs Cost-Effective................................................ 225% T/ G' M3 j) B. _8 _# b4 z
Regulatory Requirements Improve Device Safety and( a0 f' C1 S i( T* {' t; o
Effectiveness ........................................................................................ 225
. I) x4 m5 R2 \/ o( T" y; [Regulatory Affairs Requires Good Judgment ...................................... 226+ w4 \( ~ W4 d+ v1 Y$ {7 v' a
FDA Overview and Authority................................................................... 226" f8 v0 p7 V& H' G9 G
Important FDA Jurisdiction Acts, History, and Assistance................. 227
) W* d$ n% O3 ZOnline Assistance .................................................................................. 227
! Q ?, y* t7 `; y u3 QThe Basics: Short Discussion of Establishment Registration,; ^" |: I% P, U @: U& Z; f7 H
Device Submissions, Device Listing, and Device
. |8 s& n( M) h1 UClassification............................................................................................. 228, Q+ T8 ?& q3 o
Establishment Registration .................................................................... 228
: j8 H, p: t: m: V' W% n: O" ^Device Listing ........................................................................................ 228
; r' T1 g6 p" W! R( w" VDevice Classification ............................................................................. 229
* o$ \+ w8 g" M2 g. N" |Device Functional Classification........................................................... 230" ? x" t7 R0 Z3 W. n' t
510(k) Premarket Notification .............................................................. 230
0 S) j8 v( {3 A3 y/ {, @Substantial Equivalence......................................................................... 2316 m' e' m7 ^0 [0 I1 n/ V" u
Premarket Approval Submission .......................................................... 232
+ |) L% P. w; B3 tInvestigational Device Exemption and Supporting Studies ............... 232
7 f3 s, A7 l0 W' Y6 A# w% oThird-Party Submission Review by Accredited Parties....................... 233; L- c- Z" d$ `: K/ g1 J
Importing into the U.S.......................................................................... 234' |5 ? ^$ `/ v# @) i0 ]4 q9 N9 _
Initial Importers................................................................................. 234; ]6 C5 f+ [. ^; C
Exporting Devices ................................................................................. 234- B, o' ^: q; m- e
Certificates for Foreign Government............................................... 2353 B8 k/ W4 E. D$ F( H9 N w6 k
Additional Regulations by Different States.......................................... 2355 \& U/ W! ~* Y+ K6 } ]4 U
Special Considerations............................................................................... 236& P3 i9 d1 `" m- x) k! [
Exemptions from 510(k) and GMP Requirements.............................. 236! V! b8 V2 ~" V
Class I Devices .................................................................................. 2364 Y& s" x9 |# a6 [% x/ C2 j
Class II Devices................................................................................. 236
/ t( r, i F6 q+ {. W) [Special 510(k) ........................................................................................ 237% F2 Z$ h' f7 y+ h* }$ G
Abbreviated 510(k)................................................................................ 238
( L7 ?4 |, u" hDe Novo" b9 x J9 N8 O6 u1 b
.................................................................................................. 2386 z' g+ z8 j% r8 k
Product Development Protocol............................................................ 2392 l( Q w8 ~3 A- Q, q* S8 P" ]
Humanitarian Use Device/Humanitarian Device Exemption............. 239
3 Q! h6 ^8 ~% i& J! tGood Quality and Procedural Practices .................................................. 240
7 w) c" E6 s" {1 BQuality System Regulations (QSR)....................................................... 240
& U, n" u: Y; \* Z0 t. r9 WQuality System Inspection Technique (QSIT)..................................... 241
$ A+ J* X/ S1 ]' qGood Clinical Practice .......................................................................... 241
( @* o. y# G0 N$ X1 d, I0 |7 [1 ]Good Laboratory Practices ................................................................... 242# w8 N( i' X! p" Q$ W
Regulations ........................................................................................ 242
6 S2 w" e+ G; Y5 NPreclinical Studies.................................................................................. 242' j1 D! {. ]6 f/ k! x1 P
Summary of Title 21 of the Code of Federal Regulations,; l% h4 h# T+ [. o( G
Parts 800 to 1299, for Medical Devices ................................................. 243
9 g1 ]7 K3 G7 @! o* z# SPart 800: General Requirements........................................................... 243( y& S+ T. G, o
Part 801: Labeling.................................................................................. 2434 Z- p/ \9 i$ a4 y9 W% @5 X) Y
Part 803: Medical Device Reporting (MDR)........................................ 2446 G" s* n3 D# Y+ v1 @! \- ?; `' x# J
Part 806: Medical Devices: Reports of Corrections* ]: l' V4 i2 }
and Removals ...................................................................................... 246* ~7 y4 I# d* c8 A
Part 807: Establishment Registration and Device Listing for7 v0 Y& l" \( y8 f* F& l% }
Manufacturer and Individual Importers of Devices ......................... 246
3 @2 m: s" W/ E3 z9 K( ]7 Z+ @Part 808: Exemptions from Federal Preemption of State and
: F/ W& n {# O/ o1 Z1 \" ^Local Medical Device Requirements .................................................. 248) {+ Q7 s/ F5 }! y* @: C S
Part 809:
& j/ P" I5 v Z. ~6 k! _( z/ S3 |In Vitro
' y; J) c, A. ^5 \Diagnostic Products for Human Use .................... 248
4 o; t: Q# Q& v' Y9 X) E% OPart 810: Medical Device Recall Authority.......................................... 249
2 T5 c8 B3 n7 G7 c( z4 T# OPart 812: Investigational Device Exemptions...................................... 250
. |' S& z8 U. `5 A+ L6 VPart 820: Quality System Regulation.................................................... 257# E) `- ~4 d% {( h. H- w, g
Part 821: Medical Device Tracking Requirements .............................. 259
' x% V" G9 S7 Z. d; J1 WPart 822: Postmarket Surveillance ........................................................ 261 w/ @2 ?9 s4 g8 O, D4 e
Part 860: Medical Device Classification Procedures ........................... 2624 A! n* y$ {. R5 s) `
Part 861: Procedures for Performance Standards
' e5 H4 |) E( c% FDevelopment ....................................................................................... 263
8 M! N, C8 t9 L# e0 e% [Parts 862 to 1050................................................................................... 264: E: i! d7 `1 m7 a1 O
Abbreviations.............................................................................................. 265% L+ K& O) R- @7 t/ v% t8 [/ D
International and National Standard Abbreviations............................ 265
/ l1 t( ^8 P1 f$ Q) W4 |Regulatory Abbreviations ...................................................................... 265 |
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