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Introduction................................................................................................ 225/ R0 f( g a* K; q
Regulatory Requirements Are Enforced by Law................................. 2256 `, M0 |) J, {/ k
Make Regulatory Affairs Cost-Effective................................................ 225. v- K5 B! {9 }
Regulatory Requirements Improve Device Safety and! n2 M- E* g+ Y+ h/ e, U
Effectiveness ........................................................................................ 225
! ` k* e# m6 U" YRegulatory Affairs Requires Good Judgment ...................................... 226. K: x* y, B r' ~8 N
FDA Overview and Authority................................................................... 226$ @- K" o0 F! _
Important FDA Jurisdiction Acts, History, and Assistance................. 227
, W1 ~$ b$ h3 {6 x+ }Online Assistance .................................................................................. 227
6 q. n" d, u" M+ u' m ~The Basics: Short Discussion of Establishment Registration,* ~% ?- o: Y( t; X% j' d6 f# y
Device Submissions, Device Listing, and Device8 X! U ~9 `; l
Classification............................................................................................. 228+ e0 F y) R+ x0 { S
Establishment Registration .................................................................... 228
7 S9 |" A0 w9 A9 g5 E/ S" w0 }Device Listing ........................................................................................ 228
% N- \) E* f9 r" gDevice Classification ............................................................................. 2298 L$ p( G; R Y& i0 v
Device Functional Classification........................................................... 230! ~) e" j1 K; R' O
510(k) Premarket Notification .............................................................. 230
t% ]' S/ B4 z( _, @, DSubstantial Equivalence......................................................................... 2318 c5 ^$ {7 }, |7 V8 |
Premarket Approval Submission .......................................................... 232( A2 }7 i; s3 J' _, x+ s1 V
Investigational Device Exemption and Supporting Studies ............... 232
. L& u' m y0 d* [9 WThird-Party Submission Review by Accredited Parties....................... 233
- Y7 l2 }- U! R" vImporting into the U.S.......................................................................... 234
: N8 k, h& _7 g$ cInitial Importers................................................................................. 234+ b, U. ]1 x2 n- W% E' {
Exporting Devices ................................................................................. 234, M0 O# ]% ?1 i. C
Certificates for Foreign Government............................................... 2354 S H. B" ^2 t+ M) u$ ?9 @
Additional Regulations by Different States.......................................... 2357 @: e7 j1 t7 L) s6 w
Special Considerations............................................................................... 236; p* J$ j% ?4 Y/ [( z
Exemptions from 510(k) and GMP Requirements.............................. 236* }3 E3 Y$ M) w0 K# C
Class I Devices .................................................................................. 2365 l5 O8 |% L& C0 }% L9 q5 W
Class II Devices................................................................................. 236" f( m! S$ C% Y$ v" P" N1 }
Special 510(k) ........................................................................................ 2379 R) M$ |- _) }, M4 u& x' o
Abbreviated 510(k)................................................................................ 238
( o8 M4 [) z/ W+ uDe Novo- O8 P2 k, M/ Y6 P7 H# L. ]6 u
.................................................................................................. 238
( _* C, e1 {& g1 Q8 h) p2 L& L- MProduct Development Protocol............................................................ 239
, r5 s. A8 a& F. u9 T9 AHumanitarian Use Device/Humanitarian Device Exemption............. 2399 f: b* O3 k& D" Y
Good Quality and Procedural Practices .................................................. 240
. h; K9 J4 k" {3 I" XQuality System Regulations (QSR)....................................................... 240
' P# q" B1 H% ]9 r& y6 r' OQuality System Inspection Technique (QSIT)..................................... 2410 @; I y- Z8 N( |! o( c" A
Good Clinical Practice .......................................................................... 241- q- R6 f4 s& a8 X
Good Laboratory Practices ................................................................... 242
- ]0 H% S0 R. F9 X) yRegulations ........................................................................................ 242: S1 I, g: E, n
Preclinical Studies.................................................................................. 242
# A; S( d4 T2 ~9 eSummary of Title 21 of the Code of Federal Regulations," u0 |" R( y8 X/ {2 T
Parts 800 to 1299, for Medical Devices ................................................. 243* o( Z9 g/ i0 R6 d& H0 G5 t& i: ]
Part 800: General Requirements........................................................... 2437 p, P X: o5 S8 o q
Part 801: Labeling.................................................................................. 2438 Z9 s+ |+ Y3 @% L6 M% G
Part 803: Medical Device Reporting (MDR)........................................ 244
1 Y' D7 _( J! D1 T/ SPart 806: Medical Devices: Reports of Corrections
9 _! A# n& J! {$ \, ~: m1 Eand Removals ...................................................................................... 246# O9 ^) [5 a d& ~9 K3 _9 B
Part 807: Establishment Registration and Device Listing for
* Q# G" n% _9 a# ~% T& vManufacturer and Individual Importers of Devices ......................... 246* G c& N/ j8 ~6 {2 ~8 w8 P
Part 808: Exemptions from Federal Preemption of State and1 \, V; d5 v& _+ j J5 d
Local Medical Device Requirements .................................................. 248
% ~8 g2 T8 s9 kPart 809:$ j" A3 K& h$ d, R6 N2 K: o0 S$ j
In Vitro' B$ [- e# o" a
Diagnostic Products for Human Use .................... 248
5 n0 \" {: l1 C+ k* MPart 810: Medical Device Recall Authority.......................................... 249
6 q) B0 b" U0 f/ yPart 812: Investigational Device Exemptions...................................... 250' C( R) h7 p1 ]" `1 u4 H/ l( h* l/ z
Part 820: Quality System Regulation.................................................... 257
x2 d+ R- f$ P$ sPart 821: Medical Device Tracking Requirements .............................. 259' J2 v3 G3 b% I
Part 822: Postmarket Surveillance ........................................................ 2617 I3 Z# p4 K9 t! a
Part 860: Medical Device Classification Procedures ........................... 262
! h% }. P. C4 f9 APart 861: Procedures for Performance Standards
/ F" c; P0 q& k0 p8 [# jDevelopment ....................................................................................... 263 b' l. x( H) P+ X1 Y) p
Parts 862 to 1050................................................................................... 264- p$ [9 a8 x8 |% v( s
Abbreviations.............................................................................................. 265
- s' S7 y- g9 I! fInternational and National Standard Abbreviations............................ 265
6 ^6 Z* F6 w- P; {Regulatory Abbreviations ...................................................................... 265 |
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