From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 2 Jun 2008 06:26:15 -0500 (CDT)
Subject: CDRH New Update
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| FDA Home Page | CDRH Home Page | Search | A-Z Index |  | |
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 | Date: June 2, 2008 |
The following new items were added to the CDRH web pages on May 30, 2008. Previous CDRH New Items can be found on the CDRHNew Page.
 | Federal Register: Cardiovascular Devices; Reclassification of Certain Percutaneous Transluminal Coronary Angioplasty Catheters. |  |  |
| Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty Catheters; Availability. | | |
| Federal Register: Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Full Field Digital Mammography System; Availability. | | |
| Federal Register: General and Plastic Surgery Devices; Reclassification of the Tissue Adhesive for Topical Approximation of Skin Device. | | |
| Federal Register: Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin; Availability. | | |
| Federal Register: Medical Devices; Radiology Devices; Reclassification of Full Field Digital Mammography System. | | |
| Ophthalmic Devices Panel Advisory Meeting, April 24-25, 2008 - Minutes | |
Updates: 2
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 2 Jun 2008 09:05:12 -0500 (CDT)
Subject: FDA Data Standards Update - FDA Substance Registration System User's Guide Version 5c
Greetings,
The FDA Data Standards Council's Substance Registration System - UNII web page has been updated to include a link to the revised FDA Substance Registration System User's Guide. Version 5c supersedes version 5b.
The guide is accessible via a hyperlink on this web page http://www.fda.gov/oc/datacouncil/SRS.htm or this link: http://www.fda.gov/oc/datacouncil/6_10_2007SRS_Users_Guide_5C_1.pdf.
Lonnie Smith
Project Manager
FDA Data Standards Council
Updates: 3
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 2 Jun 2008 10:34:02 -0500 (CDT)
Subject: The June 2008 FDA Patient Safety News is now available...
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You can find more information about
Inflammatory Masses with Synchromed EL, Sychomed II and IsoMed Implantable Infusion Pumps
Medtronic updates patient management and treatment recommendations for patients receiving intrathecal drugs…
FDA Studying Potential Safety Issues with Several Drugs
Ongoing safety reviews of CellCept (mycophenolate mofetil), Myfortic (mycophenolic acid), Singulair (montelukast), and the Spiriva Handihaler (tiotropium)…
Neupro (rotigotine) Patches Recalled
Rotigotine may crystallize, which may affect absorption of the drug through the skin…
Avoid Using ReadyMED Infusion Pumps with Cubicin
Impurity isolated from reconstituted Cubicin that was stored in ReadyMED pumps…
Getting the Most Out of Blood Glucose Meters
Tips to help people with diabetes get accurate results from their glucose meters…
For more
Updates: 4
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 2 Jun 2008 11:04:38 -0500 (CDT)
Subject: The June 2008 MedSun Newsletter is now available...
Medical Product Safety Network
Please note a new audioconference entitled, “The Practice of Laboratory Medicine in the Twenty First Century – Achieving Relevance in a Tidal Wave of Change” has been added to the Educational Materials section.
Highlighted articles include:
The recent serious injuries and deaths associated with the use of potentially contaminated heparin are of great interest at this time. The following links contain information about the ongoing heparin issue...
Examining contemporary indications, outcomes, and complications of transvenous lead extraction in a large series of patients at a high-volume lead extraction center...
Complexity of MRI Induced Heating on Metallic Leads: Experimental Measurements of 374 Configurations
Findings highlight the factors that have significant effects on MRI induced heating of implanted wires and lead…
Although pacemakers are primarily used for the treatment of bradycardia, diagnostic data available in current pacemakers allow them to be also used as sophisticated, continuous monitoring devices...
Prevent Pediatric Medication Errors
The Joint Commission’s latest Sentinel Event Alert addresses pediatric medication errors, and urges greater attention to precautions such as medication standardization, improved medication identification and communication techniques...
Adverse drug event rates in hospitalized children are substantially higher than previously described...
Recognizing the Sources of Interference with Immunoassays
Therapeutic drug monitoring (TDM) has improved patient care but studies suggest that improvements can be made...
2008 National Patient Safety Goals Laboratory Services Program
The Joint Commission article lists laboratory program safety goals for 2008...
Some glucose meter test strips that use glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) methodology may overestimate measurements when blood maltose levels exceed certain levels...
Direct Access Testing (DAT) and the Clinical Laboratory Improvement Amendments (CLIA) Regulations
The objective of the CLIA program is to ensure quality laboratory testing...
You are subscribed to the MedSun Website, part of U.S. Food & Drug Administration (FDA).
The content on the Homepage has been updated to reflect this month's Newsletter items. This information can be viewed by clicking here.
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Updates: 5
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 2 Jun 2008 11:53:20 -0500 (CDT)
Subject: FDA Data Standards Update - Indexing SPL Guidance Document (Final)
Greetings,
The FDA Data Standards Council's SPL web page was updated to replace the hyperlink to the draft version of the Indexing Structured Product Labeling (SPL)guidance document with a link to the final version of the Indexing SPL guidance document.
The guidance document is accessible via a link on this web page http://www.fda.gov/oc/datacouncil/spl.html.
Lonnie Smith
Project Manager
FDA Data Standards Council
Updates: 6
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 2 Jun 2008 15:07:24 -0500 (CDT)
Subject: Interstate Certified Shellfish Shippers Update
* * * Interstate Certified Shellfish Shippers List * * *
The monthly ICSSL update is now available for download at http://www.cfsan.fda.gov/~ear/shellfis.html.
June 2008 Update
Updates: 7
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 2 Jun 2008 16:04:16 -0500 (CDT)
Subject: Drug to be Discontinued: Intal Nebulizer Solution (cromolyn sodium inhalation solution, USP)
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Drug to be Discontinued: Intal Nebulizer Solution (cromolyn sodium inhalation solution, USP)
Mon, 02 Jun 2008 15:10:00 -0500
Intal Nebulizer Solution (cromolyn sodium inhalation solution, USP. Dear Healthcare Professional Letter is available for more information.
Updates: 8
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 2 Jun 2008 14:25:04 -0500 (CDT)
Subject: FDA MedWatch - The June 2008 FDA Patient Safety News is Now Available
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FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at http://www.fda.gov/psn. You may have already received notification of some of these safety issues through the MedWatch list serve. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to educators in healthcare facilities and academic institutions.
Stories in the June 2008 edition include:
Inflammatory Masses with Synchromed EL, Sychomed II and IsoMed Implantable Infusion Pumps
Medtronic updates patient management and treatment recommendations for patients receiving intrathecal drugs…
FDA Studying Potential Safety Issues with Several Drugs
Ongoing safety reviews of CellCept (mycophenolate mofetil), Myfortic (mycophenolic acid), Singulair (montelukast), and the Spiriva Handihaler (tiotropium)…
Neupro (rotigotine) Patches Recalled
Rotigotine may crystallize, which may affect absorption of the drug through the skin…
Avoid Using ReadyMED Infusion Pumps with Cubicin
Impurity isolated from reconstituted Cubicin that was stored in ReadyMED pumps…
Getting the Most Out of Blood Glucose Meters
Tips to help people with diabetes get accurate results from their glucose meters…
For more
Updates: 9
From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>
Date: Mon, 2 Jun 2008 14:35:20 -0500 (CDT)
Subject: FDA MedWatch -Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula With Iron Powder- Product Recalled Because Of Oxidation
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Abbott notified consumers and healthcare professionals of the recall of two lots of Calcilo XD Low-Calcium/Vitamin D-Free Infant Formula with Iron powder, a low-calcium and Vitamin D-free infant formula specifically designed for the nutritional support of infants and children with hypercalcemia. The product, distributed in the United States between 06/06/06 and 04/17/08, is being recalled because small amounts of air may have entered the can, resulting in product oxidation. Consumption of highly oxidized foods can cause gastrointestinal symptoms such as nausea, vomiting, and diarrhea. Parents should contact their healthcare professional if they have any questions or concerns.
Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's press release regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Calcilo
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