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The Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) combines the functions of all the offices within Center for Devices and Radiological Health (CDRH) into one organizational unit for cradle-to-grave regulation of in vitro diagnostic devices (IVDs).
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Overview of OIVD
Office Information | Mission | Rationale | Goals | OIVD Organizational Structure | OIVD Phone and Email List | History of IVD Regulation | Introduction to OIVD Webcast |OIVD Annual Report
 
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News Headlines
(Updated 10/08/04)
• FDA issued a Guidance Document entitled “Guidance for Third Parties and FDA Staff; Third Party Review of Premarket Notifications
   
• FDA Issued a Class II Special Control Guidance Document entitled Serological Assays for the Detection of Beta-Glucan.
   
• FDA has implemented a new “Indication for Use” form and OIVD is encouraging the immediate use of this form with all 510(k) submissions.
   
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Updated October 8, 2004

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