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(ODE Logo) Device Evaluation Information

Recent Items...

* ODE Annual Report for FY2006 and FY2007
* FDA-Cleared Sterilants and High Level Disinfectants with General Claims for Processing Reusable Medical and Dental Devices - September 28, 2006
* Addresses to Use for Submissions

Key Topics...

* Medical Device Approvals
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510(k)s

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PMAs

  * HDEs
  * IDEs
  * Third Party Review
  * PDP
  * Site Visit
  * Vendor Day
  * Intern
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  * Advisory committee
  * Workshops
  * Other CDRH
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ODE guidance documents

  * Annual reports
  * Forms
  * Blue Book Memos
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Device Advice

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Device classification

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FDAMA

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Code of Federal Regulations

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Least Burdensome

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Medical Device User Fee and Modernization Act of 2002

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Ombudsman

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Dockets Management

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  Organization
  What We Do
  Contacts
     

Updated June 20, 2008

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