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: Wed, 30 Jan 2008 05:49:04 -0600 (CST)
Subject: CDRH New Update

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Date: January 30, 2008

The following new items were added to the CDRH web pages on January 29, 2008. Previous CDRH New Items can be found on the CDRHNew Page.

Guidance for Industry and FDA Staff: Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices

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Message: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 30 Jan 2008 08:15:20 -0600 (CST)
Subject: FDA Warning Letters Update

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

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Message: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 30 Jan 2008 08:49:52 -0600 (CST)
Subject: Medical Device Recalls: AM2 PAT Inc. Pre-Filled Heparin Lock Flush Syringes and Normal Saline IV Flush Syringes

You are subscribed to Medical Device Recalls for U.S. Food & Drug Administration (FDA). Information about the  AM2 PAT Inc. Pre-Filled Heparin Lock Flush Syringes and Normal Saline IV Flush Syringes Class I Recall has recently been updated, and is now available.

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Message: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Wed, 30 Jan 2008 14:05:47 -0600 (CST)
Subject: Nationwide Recall of NuCel Labs Eye Drops and Eye/Ear Wash Products (Jan. 29)

Nationwide Recall of NuCel Labs Eye Drops and Eye/Ear Wash Products (Jan. 29)
Wed, 30 Jan 2008 12:30:00 -0600

NuCel Labs of Idaho Falls, Idaho announced today that it is conducting a voluntary nationwide recall of all Eye Drops and Eye/Ear Wash. This recall follows an FDA inspection in which product testing indicated that there was bacteria and particulate matter in the product deeming these products non-sterile. Non-sterile eye drops pose an unacceptable risk of causing eye infections, which in rare cases could lead to blindness.

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