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Introduction................................................................................................ 225
$ [. P* w' i6 z0 k& VRegulatory Requirements Are Enforced by Law................................. 225
, `, ?; ] Y% W7 o) u; n" j4 H0 F/ gMake Regulatory Affairs Cost-Effective................................................ 225
& E' V' _/ o' CRegulatory Requirements Improve Device Safety and2 c) w/ n6 M( ^0 z
Effectiveness ........................................................................................ 225$ e% I# }* ~7 z$ a0 a( |/ D n( n
Regulatory Affairs Requires Good Judgment ...................................... 2267 W9 C/ C* @5 T+ }* c9 ~" `
FDA Overview and Authority................................................................... 2263 O8 Y2 o- p$ l
Important FDA Jurisdiction Acts, History, and Assistance................. 227
4 I0 o5 q: ?- d/ q8 aOnline Assistance .................................................................................. 227
# b" c1 w( L6 E+ i! @* M) w# Z, ]* |The Basics: Short Discussion of Establishment Registration,( u8 x; D. Y! W. M# @
Device Submissions, Device Listing, and Device5 w. l6 `2 ? K- b# z
Classification............................................................................................. 228
. z$ b3 Q8 @9 G9 H. H/ z, nEstablishment Registration .................................................................... 228+ r; ^8 C8 k% o4 |4 _1 g# W
Device Listing ........................................................................................ 228/ \; v7 Q; s% {) _/ J0 u
Device Classification ............................................................................. 2293 ^/ N; T" l' [/ U* S h/ m) t' C
Device Functional Classification........................................................... 230
8 D u" ~% p M: k: m% L510(k) Premarket Notification .............................................................. 230$ ?/ `/ x. j. \! n( T
Substantial Equivalence......................................................................... 2310 h0 M& Z; W3 }' T
Premarket Approval Submission .......................................................... 232
8 y% N& b7 B( G7 OInvestigational Device Exemption and Supporting Studies ............... 232
_* o6 q4 L! J% ^, I, `7 K+ DThird-Party Submission Review by Accredited Parties....................... 233
9 [7 N( `- R* PImporting into the U.S.......................................................................... 2345 V3 @ }; \ T* L, z) E& V
Initial Importers................................................................................. 234- w0 `8 s, j( `- Y
Exporting Devices ................................................................................. 234: W# ^- f, i' x* i( Q) U. Z
Certificates for Foreign Government............................................... 235# f3 l4 \7 `; ~& k
Additional Regulations by Different States.......................................... 235
/ k2 B. j$ }8 }! q' xSpecial Considerations............................................................................... 2367 a% v8 |( Q9 C/ T( P* G
Exemptions from 510(k) and GMP Requirements.............................. 236, N5 y3 @2 K9 K X
Class I Devices .................................................................................. 236
$ Y$ O. [% l) C/ z7 K ~- AClass II Devices................................................................................. 2368 ?! `& y. R+ ]; E0 N0 t: h8 a
Special 510(k) ........................................................................................ 2374 t" G$ H: } V w
Abbreviated 510(k)................................................................................ 238
, |( t% k: W& ^. c" l, TDe Novo$ r+ T b: o: m1 E# h9 t1 M/ Q2 i* B
.................................................................................................. 238' s3 h( v* x% r0 T
Product Development Protocol............................................................ 239
$ j6 P7 j- m& ?5 h/ n1 HHumanitarian Use Device/Humanitarian Device Exemption............. 239
) p+ z" Y; S" l' Q2 aGood Quality and Procedural Practices .................................................. 240
6 @' A8 w4 y) K" @3 @. x/ {+ T& ?Quality System Regulations (QSR)....................................................... 240 t5 ^6 h3 Q; Q& n$ s- z
Quality System Inspection Technique (QSIT)..................................... 2417 ?; N- I, c1 t2 {4 F# e4 ?1 c
Good Clinical Practice .......................................................................... 241* \' O) }8 e' Z% G
Good Laboratory Practices ................................................................... 242
; m+ z+ y7 ?: V$ ?: s: ~Regulations ........................................................................................ 242: w/ S$ [- s9 j; ]9 P7 b# B1 s
Preclinical Studies.................................................................................. 242+ M, i; }3 w/ K* J, F5 @
Summary of Title 21 of the Code of Federal Regulations,
8 n4 q4 |# h* m0 w J& FParts 800 to 1299, for Medical Devices ................................................. 243
6 e+ m/ `" m O9 Y: G) R0 t: bPart 800: General Requirements........................................................... 243
|0 `# ^$ l7 g; x7 h6 _7 YPart 801: Labeling.................................................................................. 243
5 _# W, K4 M% @Part 803: Medical Device Reporting (MDR)........................................ 244
4 [- U, t/ a1 N& g L: a- h' [Part 806: Medical Devices: Reports of Corrections
4 n9 {; D0 D8 `* qand Removals ...................................................................................... 246
0 o' ]1 z/ h3 `( S9 {Part 807: Establishment Registration and Device Listing for2 _3 m8 \; {# R8 n) @ [$ ~
Manufacturer and Individual Importers of Devices ......................... 246
j/ D6 K; [' y; }# |Part 808: Exemptions from Federal Preemption of State and
" k( I2 c, S3 |4 V, V4 X" aLocal Medical Device Requirements .................................................. 248% ^' ~4 C4 c: s* g# j
Part 809:- p0 y+ u2 O1 H8 u2 s' o
In Vitro
4 D- D- A n! ~1 A3 J4 K' V# L; xDiagnostic Products for Human Use .................... 248( }, p1 q- ~8 Q4 T0 _! ^5 L/ U! _4 a) X
Part 810: Medical Device Recall Authority.......................................... 249: _/ p- k# C0 \# ]
Part 812: Investigational Device Exemptions...................................... 2505 ?) W1 W5 r' {" ^+ c$ E
Part 820: Quality System Regulation.................................................... 2579 n5 `( F$ }/ z# B+ ^
Part 821: Medical Device Tracking Requirements .............................. 259- h, ` J- g1 G4 I, T @' s" f3 M
Part 822: Postmarket Surveillance ........................................................ 261
6 Y4 ~$ U# g! E0 U& J6 `Part 860: Medical Device Classification Procedures ........................... 262
' [: o! U; q: }Part 861: Procedures for Performance Standards7 _ N1 C! k# q
Development ....................................................................................... 263
& l) A1 @3 y+ `6 h$ P- h' F2 FParts 862 to 1050................................................................................... 264
- N' a9 m. d- G7 i& u1 Y) d* S* {' JAbbreviations.............................................................................................. 265" \2 c# a; C8 S; S! q! o8 F
International and National Standard Abbreviations............................ 265
! R2 f- J0 q% ]3 l! n# }) pRegulatory Abbreviations ...................................................................... 265 |
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