REGULATORY AFFAIRS: MEDICAL DEVICES

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Introduction................................................................................................ 225
Regulatory Requirements Are Enforced by Law................................. 225
& r+ V; V7 B( o: R. F: iMake Regulatory Affairs Cost-Effective................................................ 225
Regulatory Requirements Improve Device Safety and
Effectiveness ........................................................................................ 225
& ]3 v$ U( L" Q6 j: N" eRegulatory Affairs Requires Good Judgment ...................................... 226
FDA Overview and Authority................................................................... 226
2 [1 M5 [! W: W$ ?& g5 ^Important FDA Jurisdiction Acts, History, and Assistance................. 227
/ x9 ~. s; h: {) G& [Online Assistance .................................................................................. 227
The Basics: Short Discussion of Establishment Registration,
Device Submissions, Device Listing, and Device
" `- N( C0 H( iClassification............................................................................................. 228
Establishment Registration .................................................................... 228
Device Listing ........................................................................................ 228
Device Classification ............................................................................. 229
Device Functional Classification........................................................... 230
  _" W, \0 |* Y% k5 h510(k) Premarket Notification .............................................................. 230
; L# P9 ?. Q* ~Substantial Equivalence......................................................................... 231
- L7 r: k$ e% i3 I& V5 }$ ^5 ZPremarket Approval Submission .......................................................... 232
! M; n) [4 T  T- R/ N4 E+ {Investigational Device Exemption and Supporting Studies ............... 232
! Y9 f  _! J1 V7 A! ?Third-Party Submission Review by Accredited Parties....................... 233
0 B, Z  z1 j8 i# o/ g# p7 lImporting into the U.S.......................................................................... 234
0 E+ G& ~% q/ ]4 j7 b' C0 b6 a; ~! w3 IInitial Importers................................................................................. 234
1 P2 p2 i4 d& IExporting Devices ................................................................................. 234
$ a3 J  |" ~7 Y. CCertificates for Foreign Government............................................... 235
2 D6 x$ G- p! U% ^Additional Regulations by Different States.......................................... 235
Special Considerations............................................................................... 236
Exemptions from 510(k) and GMP Requirements.............................. 236
Class I Devices .................................................................................. 236
Class II Devices................................................................................. 236
7 y5 ~# c( B# v1 A4 [Special 510(k) ........................................................................................ 237
8 P5 G8 x3 y- x! q2 r/ ?Abbreviated 510(k)................................................................................ 238
- N# R+ G  I, wDe Novo
8 ^) m; W! Z/ i$ U.................................................................................................. 238
+ C' S0 J! B8 u3 RProduct Development Protocol............................................................ 239
Humanitarian Use Device/Humanitarian Device Exemption............. 239
Good Quality and Procedural Practices .................................................. 240
: @4 l" q1 J0 |" J( MQuality System Regulations (QSR)....................................................... 240
Quality System Inspection Technique (QSIT)..................................... 241
, l# V) o3 y/ w  g' |4 u- XGood Clinical Practice .......................................................................... 241
Good Laboratory Practices ................................................................... 242
4 C; M  m' _5 b, _  \1 pRegulations ........................................................................................ 242
Preclinical Studies.................................................................................. 242
! Y7 E7 ?2 A  t: j( M8 D0 ESummary of Title 21 of the Code of Federal Regulations,
$ ~% B2 O2 h  e6 KParts 800 to 1299, for Medical Devices ................................................. 243
; _$ }0 n, G/ U& B7 ]/ E7 z4 ^3 |/ hPart 800: General Requirements........................................................... 243
+ J! S! o, _* M! r6 TPart 801: Labeling.................................................................................. 243
Part 803: Medical Device Reporting (MDR)........................................ 244
8 n/ D7 A1 A8 m) ~Part 806: Medical Devices: Reports of Corrections
# {  ^/ I9 g  A' Vand Removals ...................................................................................... 246
. F* ?* {5 a9 q8 L* W. x/ TPart 807: Establishment Registration and Device Listing for
) T! v4 e( w: a& {Manufacturer and Individual Importers of Devices ......................... 246
Part 808: Exemptions from Federal Preemption of State and
6 m% J5 v9 u( P  z: }Local Medical Device Requirements .................................................. 248
  H& Q6 O! y) T; x( CPart 809:
In Vitro
* C7 p5 a9 y# f, v4 aDiagnostic Products for Human Use .................... 248
5 D5 m. q/ l# H8 K" G  R' P; uPart 810: Medical Device Recall Authority.......................................... 249
Part 812: Investigational Device Exemptions...................................... 250
6 V1 _; j7 k  q+ h0 l2 ~Part 820: Quality System Regulation.................................................... 257
, ^" z* G& i3 J1 a, [Part 821: Medical Device Tracking Requirements .............................. 259
Part 822: Postmarket Surveillance ........................................................ 261
Part 860: Medical Device Classification Procedures ........................... 262
, ?- h1 Q# E& \4 d. `  mPart 861: Procedures for Performance Standards
* y1 a$ o4 a- bDevelopment ....................................................................................... 263
Parts 862 to 1050................................................................................... 264
8 S4 p* B% ]+ EAbbreviations.............................................................................................. 265
International and National Standard Abbreviations............................ 265
" j/ U5 |+ l) D& F& _5 r, xRegulatory Abbreviations ...................................................................... 265