U.S. Food & Drug Administration (FDA) Daily Digest Bulletin

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Message: 1
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 21 Apr 2008 06:02:12 -0500 (CDT)
Subject: CDRH New Update

	FDA Home Page | CDRH Home Page | Search | A-Z Index

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	Federal Register: Draft Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff: Certifications to Accompany Drug, Biological Product, and Device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

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 21 Apr 2008 09:05:03 -0500 (CDT)
Subject: KFC Issues a Nationwide Allergy Alert, Recalls Unlabeled Double Chocolate Chip Cakes (April 18)

KFC Issues a Nationwide Allergy Alert, Recalls Unlabeled Double Chocolate Chip Cakes (April 18)
Mon, 21 Apr 2008 08:33:00 -0500

KFC Corporation is voluntarily recalling its Double Chocolate Chip Cakes because they contain eggs, milk, wheat, soy ingredients and possibly traces of tree nuts, and are not individually labeled with ingredient information.

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Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 21 Apr 2008 16:07:20 -0500 (CDT)
Subject: FDA Approves First Compact Heart Assist Device

FDA Approves First Compact Heart Assist Device
Mon, 21 Apr 2008 16:03:00 -0500

The U.S. Food and Drug Administration today approved a heart assist device with a novel design that is the first to mechanically support the weakened heart of a small-sized adult man or woman with heart failure who is at risk of dying while awaiting a heart transplant.

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