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Introduction................................................................................................ 225% F8 D* G* y* f. H
Regulatory Requirements Are Enforced by Law................................. 2256 k4 a0 J# N, v& z: g- v
Make Regulatory Affairs Cost-Effective................................................ 2252 `4 \' Q) O P
Regulatory Requirements Improve Device Safety and8 U; p) `" A7 ^8 a- b3 X8 v
Effectiveness ........................................................................................ 225# X8 B1 J- G; _; \. ?4 w a F
Regulatory Affairs Requires Good Judgment ...................................... 226
( M& r: o2 c4 E) F& QFDA Overview and Authority................................................................... 226
- C: a1 X, a0 U' q: i6 jImportant FDA Jurisdiction Acts, History, and Assistance................. 227
. |0 N( B' T8 v# j* R0 Z( ^Online Assistance .................................................................................. 227
- t/ J: {: ]7 B$ O nThe Basics: Short Discussion of Establishment Registration,
) D! n4 K# N: Z2 }+ }" S; [Device Submissions, Device Listing, and Device" o [3 q \; e4 g. `+ K8 [6 p/ A
Classification............................................................................................. 228
q) |1 n! F# ~2 K1 t- iEstablishment Registration .................................................................... 228
3 Y* J" V6 [2 ?" v: rDevice Listing ........................................................................................ 228
; x8 @) T4 u9 K( o( O2 CDevice Classification ............................................................................. 229/ _7 g- b+ i) j3 V
Device Functional Classification........................................................... 230. `+ u5 v$ a9 {
510(k) Premarket Notification .............................................................. 230
. z1 e" m1 T* J! ~2 XSubstantial Equivalence......................................................................... 231
9 E6 R9 G8 x1 u5 APremarket Approval Submission .......................................................... 2324 |5 n3 k/ R/ j! P+ u1 p8 j" J
Investigational Device Exemption and Supporting Studies ............... 2322 \* W" K( N. P( C2 D
Third-Party Submission Review by Accredited Parties....................... 233* |+ l& \' G$ ~; @
Importing into the U.S.......................................................................... 234
$ q' T+ x! c3 O$ oInitial Importers................................................................................. 2349 t$ U- m" \) p. A# Z
Exporting Devices ................................................................................. 2342 x0 }7 C, O! D3 j( H5 H: e' L6 i- t
Certificates for Foreign Government............................................... 2355 ^+ _$ T* q( I( n) W
Additional Regulations by Different States.......................................... 235
u4 z4 R4 ~. e/ n- a* cSpecial Considerations............................................................................... 236 N4 t" x# u- s6 e% |1 V# W
Exemptions from 510(k) and GMP Requirements.............................. 236
$ Y! M3 q* I, w6 V' G {7 `Class I Devices .................................................................................. 236
O8 G6 W7 w9 {& b/ wClass II Devices................................................................................. 2367 q, R- L3 v* Z) h
Special 510(k) ........................................................................................ 237
/ U7 I. F7 @: T: i YAbbreviated 510(k)................................................................................ 2389 W! O' E# j9 r5 U* U( c# t
De Novo
$ r0 O7 t. {3 W" k1 c.................................................................................................. 238
0 r! l. h5 R$ t- N0 d" F: m2 S. sProduct Development Protocol............................................................ 239
+ Y0 G8 q: U4 }+ Y: U+ ]7 u, UHumanitarian Use Device/Humanitarian Device Exemption............. 239
" o) d* w+ J% q5 K. o1 d" sGood Quality and Procedural Practices .................................................. 240
, M. ^9 o {: M3 WQuality System Regulations (QSR)....................................................... 2400 n3 v) `' R4 M2 R6 \/ e
Quality System Inspection Technique (QSIT)..................................... 241
/ d7 j) y# x% }- xGood Clinical Practice .......................................................................... 241
$ c v! Z1 F7 O) H4 R& O. `! A$ CGood Laboratory Practices ................................................................... 242
: o) }# H1 P; DRegulations ........................................................................................ 242
9 _# y; S8 V/ A( M6 zPreclinical Studies.................................................................................. 242
) v$ w v! Z6 o& z7 x r1 u8 g# CSummary of Title 21 of the Code of Federal Regulations,8 S9 p( g5 m# r# Y
Parts 800 to 1299, for Medical Devices ................................................. 243
" r8 u+ E* p% |, [# DPart 800: General Requirements........................................................... 243
, m/ P, H# `8 R) }Part 801: Labeling.................................................................................. 2431 V, a8 c& V. l+ z. e
Part 803: Medical Device Reporting (MDR)........................................ 244# B2 U' z& R6 F
Part 806: Medical Devices: Reports of Corrections- l4 Z4 Q0 i2 M. [
and Removals ...................................................................................... 246: ?$ h) }* e8 j4 Q, a1 l
Part 807: Establishment Registration and Device Listing for
: |1 t' U6 k8 }/ k. H! H) ?' X$ wManufacturer and Individual Importers of Devices ......................... 246
5 z) L7 `& L2 {1 k$ O# p& e* hPart 808: Exemptions from Federal Preemption of State and' l* A, M! e" R" u7 }# \- a: o/ t
Local Medical Device Requirements .................................................. 248
- [. a7 U8 |% C0 kPart 809:
9 A3 [' m; u3 a+ MIn Vitro% b& P+ l; Y0 \* D
Diagnostic Products for Human Use .................... 248
& d, s) \% f4 k+ HPart 810: Medical Device Recall Authority.......................................... 249$ e) j) O, O# y" ]/ L7 g& o6 J+ ?) x
Part 812: Investigational Device Exemptions...................................... 250- V' F9 N1 r9 C" D i
Part 820: Quality System Regulation.................................................... 257) x" d/ p% W7 q
Part 821: Medical Device Tracking Requirements .............................. 259
% S) V$ T7 ]1 `Part 822: Postmarket Surveillance ........................................................ 261
: b! N1 O; c" [- ~. m5 W, SPart 860: Medical Device Classification Procedures ........................... 2620 p5 R7 |# S' p. a! T' ^9 [
Part 861: Procedures for Performance Standards9 |: a7 y' E( Y0 g3 P
Development ....................................................................................... 263! x; }3 n0 `$ ~( F
Parts 862 to 1050................................................................................... 264
" L9 [" g2 M% M5 T7 t- EAbbreviations.............................................................................................. 265: T' O0 |8 Y# f4 U
International and National Standard Abbreviations............................ 265/ y: [& j: Z2 M9 A
Regulatory Abbreviations ...................................................................... 265 |
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