REGULATORY AFFAIRS: MEDICAL DEVICES
Introduction................................................................................................ 225Regulatory Requirements Are Enforced by Law................................. 225
Make Regulatory Affairs Cost-Effective................................................ 225
Regulatory Requirements Improve Device Safety and
Effectiveness ........................................................................................ 225
Regulatory Affairs Requires Good Judgment ...................................... 226
FDA Overview and Authority................................................................... 226
Important FDA Jurisdiction Acts, History, and Assistance................. 227
Online Assistance .................................................................................. 227
The Basics: Short Discussion of Establishment Registration,
Device Submissions, Device Listing, and Device
Classification............................................................................................. 228
Establishment Registration .................................................................... 228
Device Listing ........................................................................................ 228
Device Classification ............................................................................. 229
Device Functional Classification........................................................... 230
510(k) Premarket Notification .............................................................. 230
Substantial Equivalence......................................................................... 231
Premarket Approval Submission .......................................................... 232
Investigational Device Exemption and Supporting Studies ............... 232
Third-Party Submission Review by Accredited Parties....................... 233
Importing into the U.S.......................................................................... 234
Initial Importers................................................................................. 234
Exporting Devices ................................................................................. 234
Certificates for Foreign Government............................................... 235
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
Special 510(k) ........................................................................................ 237
Abbreviated 510(k)................................................................................ 238
De Novo
.................................................................................................. 238
Product Development Protocol............................................................ 239
Humanitarian Use Device/Humanitarian Device Exemption............. 239
Good 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
Summary of Title 21 of the Code of Federal Regulations,
Parts 800 to 1299, for Medical Devices ................................................. 243
Part 800: General Requirements........................................................... 243
Part 801: Labeling.................................................................................. 243
Part 803: Medical Device Reporting (MDR)........................................ 244
Part 806: Medical Devices: Reports of Corrections
and Removals ...................................................................................... 246
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:
In Vitro
Diagnostic Products for Human Use .................... 248
Part 810: Medical Device Recall Authority.......................................... 249
Part 812: Investigational Device Exemptions...................................... 250
Part 820: Quality System Regulation.................................................... 257
Part 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
Parts 862 to 1050................................................................................... 264
Abbreviations.............................................................................................. 265
International and National Standard Abbreviations............................ 265
Regulatory Abbreviations ...................................................................... 265
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