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, 25 Feb 2008 05:41:24 -0600 (CST)
Subject: CDRH New Update

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Date: February 25, 2008

The following new items were added to the CDRH web pages on February 22, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

Guidance for Industry: Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 25 Feb 2008 08:27:40 -0600 (CST)
Subject: Public Health Notifications Update

You are subscribed to Public Health Notifications for U.S. Food & Drug Administration (FDA), Center for Devices and Radiological Health.

The FDA has posted a new Public Health Notification regarding Denture Cleanser Allergic Reactions and Misuse.  This Notification provides information about the potential for allergic reactions due to persulfates and stresses the importance of following the product directions for use.

This Notification and accompanying Advice for Patients is available by clicking here.

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Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 25 Feb 2008 15:40:15 -0600 (CST)
Subject: Denture Cleanser Allergic Reactions and Misuse - Medical Device Safety Update

Healthcare providers should be aware of a new public health notification that recommends specific actions to prevent or minimize serious patient injuries and allergic reactions related to the use of denture cleansers.

You are subscribed to Medical Device Safety for U.S. Food & Drug Administration (FDA).

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