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

Update: 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

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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	Federal Register: Draft Guidance for Sponsors, Industry, Researchers, Investigators, and Food and Drug Administration Staff: Certifications to Accompany Drug, Biological Product, and Device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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Update: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 21 Apr 2008 07:10:58 -0500 (CDT)
Subject: U.S. Food & Drug Administration (FDA) CBER's Guidances Update

You are subscribed to CBER's Guidances for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.

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) of The Public Health Service Act, Added By Title VIII of The Food and Drug Administration Amendments Act of 2007 - 4/21/2008

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Update: 3
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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Update: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 21 Apr 2008 10:07:55 -0500 (CDT)
Subject: U.S. Food & Drug Administration (FDA) CBER's Recalls, Withdrawals, Field Corrections & Notifications Update

You are subscribed to CBER's Recalls, Withdrawals, Field Corrections & Notifications for U.S. Food & Drug Administration (FDA). This information has recently been updated, and is now available.

Important Product Correction Notification: Blood Grouping Reagent Anti-S for Indirect Antiglobulin Tests - Ortho Clinical Diagnostics, Inc - 4/21/2008

Recall of Rho(D) Immune Globulin (Human); Hyper RHO S/D, Mini-Dose - Talecris Biotherapeutics, Inc - 4/18/2008

Medical Device Notification: Sunquest Laboratory Blood Bank and Blood Donor Modules - Sunquest Information Systems, Inc - 3/26/2008

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Update: 5
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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