REGULATORY AFFAIRS: MEDICAL DEVICES

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Introduction................................................................................................ 225
' y  K3 k! n3 k$ SRegulatory Requirements Are Enforced by Law................................. 225
! A0 @) G, m  }# w9 I9 MMake Regulatory Affairs Cost-Effective................................................ 225
/ t) G# Y0 g9 i, Z: [1 @3 K/ IRegulatory Requirements Improve Device Safety and
: f! n/ w+ o& T* @6 }6 CEffectiveness ........................................................................................ 225
; u2 B. K9 ^2 P& ERegulatory Affairs Requires Good Judgment ...................................... 226
FDA Overview and Authority................................................................... 226
Important FDA Jurisdiction Acts, History, and Assistance................. 227
5 U: H' x. E' P1 jOnline Assistance .................................................................................. 227
The Basics: Short Discussion of Establishment Registration,
Device Submissions, Device Listing, and Device
Classification............................................................................................. 228
Establishment Registration .................................................................... 228
" `/ t+ s' w1 PDevice Listing ........................................................................................ 228
1 B) O; X; c  \8 U% j  u: W3 S; qDevice Classification ............................................................................. 229
% L: e0 j% Q  R) NDevice Functional Classification........................................................... 230
510(k) Premarket Notification .............................................................. 230
7 e6 t% ~8 J; B# Z6 X8 XSubstantial Equivalence......................................................................... 231
7 m. v0 _; W7 `  wPremarket Approval Submission .......................................................... 232
! m4 Z* n. \3 \9 p" hInvestigational Device Exemption and Supporting Studies ............... 232
Third-Party Submission Review by Accredited Parties....................... 233
% g- }: b) h6 `: u4 N' n% xImporting into the U.S.......................................................................... 234
Initial Importers................................................................................. 234
Exporting Devices ................................................................................. 234
( o: l9 H" K# \6 mCertificates for Foreign Government............................................... 235
Additional Regulations by Different States.......................................... 235
+ D; _1 j$ ~) C, bSpecial Considerations............................................................................... 236
0 S# D+ h, L- L+ ~* o: rExemptions from 510(k) and GMP Requirements.............................. 236
Class I Devices .................................................................................. 236
Class II Devices................................................................................. 236
& y' u6 P' B+ [Special 510(k) ........................................................................................ 237
Abbreviated 510(k)................................................................................ 238
1 p1 |5 h4 o9 EDe Novo
.................................................................................................. 238
Product Development Protocol............................................................ 239
' J! o4 s- y: ]' N% l7 qHumanitarian Use Device/Humanitarian Device Exemption............. 239
, v) ]' y+ v  ZGood Quality and Procedural Practices .................................................. 240
* r% R, y: I+ z8 L3 L5 `$ z; SQuality System Regulations (QSR)....................................................... 240
: c9 z0 u, W) A3 @1 E+ d* ?Quality System Inspection Technique (QSIT)..................................... 241
Good Clinical Practice .......................................................................... 241
Good Laboratory Practices ................................................................... 242
Regulations ........................................................................................ 242
* `& l, J2 I# {- C0 F  tPreclinical Studies.................................................................................. 242
Summary of Title 21 of the Code of Federal Regulations,
0 w2 p# v4 P9 u7 t( @, T& J  V7 S% u- K3 JParts 800 to 1299, for Medical Devices ................................................. 243
Part 800: General Requirements........................................................... 243
8 F  A  p  s8 c! A  kPart 801: Labeling.................................................................................. 243
Part 803: Medical Device Reporting (MDR)........................................ 244
Part 806: Medical Devices: Reports of Corrections
8 m# E1 `5 a: \, E. G* O* P3 |) iand Removals ...................................................................................... 246
: ~  `. l/ u& }! A& |Part 807: Establishment Registration and Device Listing for
Manufacturer and Individual Importers of Devices ......................... 246
Part 808: Exemptions from Federal Preemption of State and
Local Medical Device Requirements .................................................. 248
Part 809:
5 _. `. O$ Y1 R0 b& w0 y0 R# LIn Vitro
9 S* Q2 m; ^9 E8 rDiagnostic Products for Human Use .................... 248
1 U8 d! [4 {6 e8 f! p+ HPart 810: Medical Device Recall Authority.......................................... 249
Part 812: Investigational Device Exemptions...................................... 250
Part 820: Quality System Regulation.................................................... 257
1 [& v) }/ b/ nPart 821: Medical Device Tracking Requirements .............................. 259
6 ~4 F" y9 }$ vPart 822: Postmarket Surveillance ........................................................ 261
" S( }6 W! \: P* [# ?Part 860: Medical Device Classification Procedures ........................... 262
Part 861: Procedures for Performance Standards
Development ....................................................................................... 263
6 ^& w9 |( e3 m- ^8 J* ]Parts 862 to 1050................................................................................... 264
Abbreviations.............................................................................................. 265
) L# z: D$ L9 f4 L, f; ]7 ^, ZInternational and National Standard Abbreviations............................ 265
Regulatory Abbreviations ...................................................................... 265