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(ODE Logo)Device Evaluation Information

Recent Items...
* 2004 FDA Workshop on Pre-Clinical Testing for Endovascular Grafts
* MOU - Procedures for Listing Medical Devices and In Vitro Diagnostic Products Exempted from Premarket Notification [510(k)] on the Internet
* Medical Device User Fee and Modernization Act of 2002

Key Topics...
* Medical Device Approvals
*

Programs
  *

510(k)s
  *

PMAs
  * HDEs
  * IDEs
  * Third Party Review
  * PDP
  * Site Visit
  * Vendor Day
  * Intern
*

Meetings
  * Advisory committee
  * Workshops
  * Other CDRH
*

Documents
  *

ODE guidance documents
  * Annual reports
  * Forms
  * Blue Book Memos
*

Resources
  *

Device Advice
  *

Device classification
  *

FDAMA
  *

Code of Federal Regulations
  *

Least Burdensome
  *

Medical Device User Fee and Modernization Act of 2002
  *

Ombudsman
  *

Dockets Management
* Office of Device Evaluation
  * Organization
  * What We Do
  * Contacts
     

Updated July 1, 2003

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