REGULATORY AFFAIRS: MEDICAL DEVICES

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Introduction................................................................................................ 225
Regulatory Requirements Are Enforced by Law................................. 225
Make Regulatory Affairs Cost-Effective................................................ 225
Regulatory Requirements Improve Device Safety and
: N- q- e, P0 |) qEffectiveness ........................................................................................ 225
Regulatory Affairs Requires Good Judgment ...................................... 226
9 [  r  g# L% A8 JFDA Overview and Authority................................................................... 226
Important FDA Jurisdiction Acts, History, and Assistance................. 227
2 Y  Y9 k1 x7 A; |% X+ SOnline Assistance .................................................................................. 227
: \1 L6 J5 ^4 z: A( @- t3 A9 L' c/ o5 S( u+ GThe Basics: Short Discussion of Establishment Registration,
Device Submissions, Device Listing, and Device
  V, J, W" R, i* @+ k1 K* X. ]Classification............................................................................................. 228
Establishment Registration .................................................................... 228
Device Listing ........................................................................................ 228
: O0 d# P1 H: A" GDevice Classification ............................................................................. 229
Device Functional Classification........................................................... 230
510(k) Premarket Notification .............................................................. 230
$ z7 {* ?+ n0 ~( xSubstantial Equivalence......................................................................... 231
' Q6 `1 E! ^7 U/ i: t: U) sPremarket Approval Submission .......................................................... 232
5 U9 T9 d9 C2 M0 r& `# x, nInvestigational Device Exemption and Supporting Studies ............... 232
Third-Party Submission Review by Accredited Parties....................... 233
Importing into the U.S.......................................................................... 234
/ C4 X& Y* X4 }: t+ x" sInitial Importers................................................................................. 234
0 w8 m8 R+ E7 j7 B9 T5 AExporting Devices ................................................................................. 234
/ ?/ c! l9 E. O- c" i  F( tCertificates for Foreign Government............................................... 235
Additional Regulations by Different States.......................................... 235
' A; u' X8 S7 B! c' u/ G: q# OSpecial Considerations............................................................................... 236
* K1 C; t& A2 o8 V1 S: rExemptions from 510(k) and GMP Requirements.............................. 236
  f% }; O% p9 s' k' ^6 QClass I Devices .................................................................................. 236
: {5 Y- `! @  _( B" s* `Class II Devices................................................................................. 236
Special 510(k) ........................................................................................ 237
  b) X9 Z  v# `' h# P6 C" JAbbreviated 510(k)................................................................................ 238
De Novo
* s" {) }# W- D! u, q% z5 R  [4 a.................................................................................................. 238
Product Development Protocol............................................................ 239
1 `% E! Z- ~0 p5 b8 y- n9 ]Humanitarian Use Device/Humanitarian Device Exemption............. 239
9 m1 T* v1 M; eGood Quality and Procedural Practices .................................................. 240
Quality System Regulations (QSR)....................................................... 240
Quality System Inspection Technique (QSIT)..................................... 241
Good Clinical Practice .......................................................................... 241
Good Laboratory Practices ................................................................... 242
Regulations ........................................................................................ 242
Preclinical Studies.................................................................................. 242
  f" M9 o5 |; R5 T+ _* T: cSummary of Title 21 of the Code of Federal Regulations,
Parts 800 to 1299, for Medical Devices ................................................. 243
) w' q" l" l. x7 F- e% iPart 800: General Requirements........................................................... 243
Part 801: Labeling.................................................................................. 243
; Y7 o- h0 v$ [* T- R3 ^Part 803: Medical Device Reporting (MDR)........................................ 244
Part 806: Medical Devices: Reports of Corrections
5 `. O6 p) J: x% h; a) k% nand Removals ...................................................................................... 246
: E% f% U$ G2 MPart 807: Establishment Registration and Device Listing for
' I' l' q$ S9 U/ AManufacturer and Individual Importers of Devices ......................... 246
Part 808: Exemptions from Federal Preemption of State and
1 L* I2 t5 g5 ]" w2 l7 |; OLocal Medical Device Requirements .................................................. 248
Part 809:
In Vitro
! K) B( M. z) b5 W" vDiagnostic Products for Human Use .................... 248
Part 810: Medical Device Recall Authority.......................................... 249
Part 812: Investigational Device Exemptions...................................... 250
Part 820: Quality System Regulation.................................................... 257
. o/ \" b, W/ b. N$ Y+ B# IPart 821: Medical Device Tracking Requirements .............................. 259
Part 822: Postmarket Surveillance ........................................................ 261
Part 860: Medical Device Classification Procedures ........................... 262
Part 861: Procedures for Performance Standards
Development ....................................................................................... 263
9 G1 L4 Q+ L% n( K9 i, s8 ]Parts 862 to 1050................................................................................... 264
Abbreviations.............................................................................................. 265
International and National Standard Abbreviations............................ 265
; f( \( w4 Q( E: A% V4 [Regulatory Abbreviations ...................................................................... 265