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CDRH New Update

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CDRHNEW Logo Date: April 21, 2008

The following new items were added to the CDRH web pages on April 18, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

* Federal Register: Draft Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff: Certifications to Accompany Drug, Biological Product, and Device Applications/Submissions: Compliance With Section 402(j) Text PDF
* Guidance for Industry and FDA Staff: Hemodialysis Blood Tubing Sets - Premarket Notification [510(k)] Submissions Text PDF
* Guidance for Industry and FDA Staff: Investigational Device Exemptions (IDEs) for Devices Indicated for Nocturnal Home Hemodialysis Text PDF
* Guidance for Industry and FDA Staff: Preparation and Review of Investigational Device Exemption Applications (IDEs) for Total Artificial Discs Text PDF

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