ABSTRACT
Introduction................................................................................................ 225 Regulatory 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
The first rule of regulatory affairs is that it is based on regulation; that is, it is a legal obligation. From a business point of view, it is expense, and it does contribute to the cost of doing business. Thus, for the sake of maintaining a profitable business while still providing for necessary safety and effectiveness of a medical device, regulatory affairs must be a wellplanned function and not just improvised as the need arises. For a medical device start-up company, regulatory affairs strategy and implementation must be addressed from the very beginning.
