REGULATORY AFFAIRS: MEDICAL DEVICES

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Introduction................................................................................................ 225
' i2 m8 Z3 }6 LRegulatory Requirements Are Enforced by Law................................. 225
Make Regulatory Affairs Cost-Effective................................................ 225
: i% X& m* S! @* M" t6 u7 PRegulatory Requirements Improve Device Safety and
Effectiveness ........................................................................................ 225
Regulatory Affairs Requires Good Judgment ...................................... 226
FDA Overview and Authority................................................................... 226
. `; E+ G" Z" K! }6 B2 zImportant FDA Jurisdiction Acts, History, and Assistance................. 227
Online Assistance .................................................................................. 227
# ^- h* B: J6 EThe Basics: Short Discussion of Establishment Registration,
Device Submissions, Device Listing, and Device
& u  \0 ~) p$ K& fClassification............................................................................................. 228
3 \  b+ }# F+ [* Y4 C( |0 ~Establishment Registration .................................................................... 228
- g0 \/ K1 a9 p! EDevice Listing ........................................................................................ 228
1 O6 O7 a" G; [0 C+ L' ^Device Classification ............................................................................. 229
# L6 e2 b+ L9 Q( z" k+ _Device Functional Classification........................................................... 230
510(k) Premarket Notification .............................................................. 230
Substantial Equivalence......................................................................... 231
Premarket Approval Submission .......................................................... 232
: _" O, p  ~- N: H+ qInvestigational Device Exemption and Supporting Studies ............... 232
Third-Party Submission Review by Accredited Parties....................... 233
Importing into the U.S.......................................................................... 234
Initial Importers................................................................................. 234
0 H- O. O6 Z6 E, }# J: tExporting Devices ................................................................................. 234
Certificates for Foreign Government............................................... 235
6 y; S5 A  b! _/ }4 }+ J. H1 b; WAdditional Regulations by Different States.......................................... 235
Special Considerations............................................................................... 236
Exemptions from 510(k) and GMP Requirements.............................. 236
; {4 U1 ^2 X/ i& JClass I Devices .................................................................................. 236
Class II Devices................................................................................. 236
* Y$ b" z4 k/ M5 SSpecial 510(k) ........................................................................................ 237
( T% p$ E1 i7 a2 pAbbreviated 510(k)................................................................................ 238
1 f; t8 |) r- l6 C, uDe Novo
+ {) @4 P* u9 y* S7 J; h.................................................................................................. 238
8 X2 {# K) l+ k, Z, l" VProduct Development Protocol............................................................ 239
Humanitarian Use Device/Humanitarian Device Exemption............. 239
Good Quality and Procedural Practices .................................................. 240
# ^( ~: U! ^$ g" h0 @0 mQuality System Regulations (QSR)....................................................... 240
Quality System Inspection Technique (QSIT)..................................... 241
+ i# x2 P( C- i7 xGood Clinical Practice .......................................................................... 241
( w6 l5 w# L* ?# X+ HGood Laboratory Practices ................................................................... 242
( }' G  }1 h" b* Y  D0 }* eRegulations ........................................................................................ 242
: S: E5 S" N  G4 Z* xPreclinical Studies.................................................................................. 242
- }0 G8 e( ]. VSummary of Title 21 of the Code of Federal Regulations,
0 J9 n+ t) {7 OParts 800 to 1299, for Medical Devices ................................................. 243
Part 800: General Requirements........................................................... 243
Part 801: Labeling.................................................................................. 243
Part 803: Medical Device Reporting (MDR)........................................ 244
+ C" Y; D3 b$ i" e7 D4 \Part 806: Medical Devices: Reports of Corrections
9 a! {- z4 A. ~2 X. R  l; f7 p- Rand Removals ...................................................................................... 246
; V4 D3 Q/ T: `& t. S! PPart 807: Establishment Registration and Device Listing for
Manufacturer and Individual Importers of Devices ......................... 246
& i) B* i0 V7 n7 C1 B8 FPart 808: Exemptions from Federal Preemption of State and
3 B! }- L5 V. _7 Q7 c' F; O  ELocal Medical Device Requirements .................................................. 248
Part 809:
In Vitro
Diagnostic Products for Human Use .................... 248
/ z5 ]/ {  r; \Part 810: Medical Device Recall Authority.......................................... 249
Part 812: Investigational Device Exemptions...................................... 250
8 K; S( ?6 I$ U2 v$ zPart 820: Quality System Regulation.................................................... 257
Part 821: Medical Device Tracking Requirements .............................. 259
Part 822: Postmarket Surveillance ........................................................ 261
* O2 @) S  z! R" C0 h8 v7 \1 f7 CPart 860: Medical Device Classification Procedures ........................... 262
) H+ Z, x9 J3 N) i8 U4 R1 EPart 861: Procedures for Performance Standards
Development ....................................................................................... 263
% \0 }: M5 B2 `Parts 862 to 1050................................................................................... 264
2 S3 X! a. v0 TAbbreviations.............................................................................................. 265
International and National Standard Abbreviations............................ 265
- z7 c8 Q% @4 e( L4 uRegulatory Abbreviations ...................................................................... 265