Biomedical Engineering Reference
In-Depth Information
Medical
Device
Concept
Preclinical
and/or Biocomp.
Testing
Compilance
with QS
Regulation
SR Study
Protocol
IDE
Submission
IRB
Review
NSR Study
Protocol
IRB
Review
FDA
Review
Compliance with
Recognized
Clinical
Trial
Traditional 510(k)
Notification
Abbreviated
510(k)
Special
510(k)
PMA
Aoolication
FDA
S
Accelerated
FDA 510(k)
Review
Traditional
FDA 510(k)
Review
510(k)
Exempt
E
Review
+
Legally
Marketed
Device
Abbreviations: SR, Significant Risk; NSR, Non0significant Risk; IDE, Investigational Device
Exemption; IRB, Institutional Review Board;
Figure 12.1
Selected pathways for marketing medical devices in the United States [10] (
©
Taylor
& Francis Group)
