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Class I Medical Device Recall: Physio Control, Inc. LifePak CR Plus Automated External Defibrillators (AEDs)

Published in September 10th, 2008
Posted by CDRH Consumer News in Medical Devices and Radiological Health
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Reason for Recall: The AED instructs the responder, by voice prompts, to press the shock button. However, the shock button is covered and is not visible. Therefore, the responder is not able to provide therapy (shock).

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Summary Information for: COBAS® TaqMan® HBV Test For Use With the High Pure System

Published in September 10th, 2008
Posted by Food and Drug Adminstration (FDA): CDRHNew in Medical Devices and Radiological Health
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Summary Information for: COBAS® TaqMan® HBV Test For Use With the High Pure System

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Federal Register: Public Advisory Panels or Committees: Request for Industry Organizations Interested in Participating in Selection Process for Nonvoting Industry Representatives

Published in September 10th, 2008
Posted by Food and Drug Adminstration (FDA): CDRHNew in Medical Devices and Radiological Health
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The FDA is requesting that any industry organization interested in participating in the selection of nonvoting industry representatives to serve on the Devices Good Manufacturing Practice Advisory Committee (DGMPAC) and certain device panels of the…

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Federal Register: Public Advisory Panels or Committees: Request for Industry Organizations Interested in Participating in Selection Process for Nonvoting Industry Representatives

Published in September 10th, 2008
Posted by Food and Drug Adminstration (FDA): CDRHNew in Medical Devices and Radiological Health
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The FDA is requesting that any industry organization interested in participating in the selection of nonvoting industry representatives to serve on the Devices Good Manufacturing Practice Advisory Committee (DGMPAC) and certain device panels of the…

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Federal Register: General and Plastic Surgery Devices: Reclassification of the Absorbable Hemostatic Device; Reopening of Comment Period

Published in September 10th, 2008
Posted by Food and Drug Adminstration (FDA): CDRHNew in Medical Devices and Radiological Health
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The FDA is is reopening until October 14, 2008, the comment period for a proposed rule published in the Federal Register to reclassify the absorbable hemostatic device from class III (premarket approval) into class II (special controls).

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Federal Register: General and Plastic Surgery Devices: Reclassification of the Absorbable Hemostatic Device; Reopening of Comment Period

Published in September 10th, 2008
Posted by Food and Drug Adminstration (FDA): CDRHNew in Medical Devices and Radiological Health
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The FDA is is reopening until October 14, 2008, the comment period for a proposed rule published in the Federal Register to reclassify the absorbable hemostatic device from class III (premarket approval) into class II (special controls).

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Federal Register: Class II Special Controls Guidance Document: Absorbable Hemostatic Device; Draft Guidance for Industry and Food and Drug Administration Staff; Reopening of Comment Period

Published in September 10th, 2008
Posted by Food and Drug Adminstration (FDA): CDRHNew in Medical Devices and Radiological Health
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The draft guidance describes a means by which the absorbable hemostatic device may comply with the requirements of special controls if it is reclassified. FDA is reopening the comment period to update comments and to receive any new information.

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Federal Register: Class II Special Controls Guidance Document: Absorbable Hemostatic Device; Draft Guidance for Industry and Food and Drug Administration Staff; Reopening of Comment Period

Published in September 10th, 2008
Posted by Food and Drug Adminstration (FDA): CDRHNew in Medical Devices and Radiological Health
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The draft guidance describes a means by which the absorbable hemostatic device may comply with the requirements of special controls if it is reclassified. FDA is reopening the comment period to update comments and to receive any new information.

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FDA Workshop: Best Practices For Pacemaker and ICD Lead Postmarket Surveillance, October 2-3, 2008 (Final Agenda Now Available)

Published in September 10th, 2008
Posted by Food and Drug Adminstration (FDA): CDRHNew in Medical Devices and Radiological Health
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Meeting announcement for FDA Workshop: Best Practices For Pacemaker and ICD Lead Postmarket Surveillance, October 2-3, 2008.

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Schering-Plough launches Bridion (sugammadex) in Europe

Published in September 10th, 2008
Posted by Pharmaceutical News Feed in Drugs and Food Information, Pharmaceutical Industry News
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Schering-Plough Corporation has announced that the European launch of Bridion (sugammadex) injection has begun with its introduction this week in Sweden, and that the product is expected to be available soon in the United Kingdom and Germany, with several other European markets to follow by the end of the year and in early 2009.

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