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Overview: The Food and Drug Administration Modernization Act (FDAMA) requires that manufacturers track certain devices when the agency orders them to do so. Tracking is intended to facilitate notification and recall in the event a device presents a serious risk to health that requires prompt attention. The tracking provisions enacted by SMDA required mandatory tracking even if FDA did not issue an order. Specifically, section 519(e), as added by SMDA, required manufacturers to track if they were registered with FDA under section 510 of the act and engaged in the manufacturer of a device if its failure.

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Place : United States, Fremont

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Contact Person:Event Manager

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Overview: The Food and Drug Administration Modernization Act (FDAMA) requires that manufacturers track certain devices when the agency orders them to do so. Tracking is intended to facilitate notification and recall in the event a device presents a serious risk to health that requires prompt attention. The tracking provisions enacted by SMDA required mandatory tracking even if FDA did not issue an order. Specifically, section 519(e), as added by SMDA, required manufacturers to track if they were registered with FDA under section 510 of the act and engaged in the manufacturer of a device if its failure.

Overview: The Food and Drug Administration Modernization Act (FDAMA) requires that manufacturers track certain devices when the agency orders them to do so. Tracking is intended to facilitate notification and recall in the event a device presents a serious risk to health that requires prompt attention. The tracking provisions enacted by SMDA required mandatory tracking even if FDA did not issue an order. Specifically, section 519(e), as added by SMDA, required manufacturers to track if they were registered with FDA under section 510 of the act and engaged in the manufacturer of a device if its failure. will be held in Fremont,United States on date 2016-09-07

Deadline for abstracts/proposals : 6th September 2016

Organized By :Compliance4All

Keynote Speakers :

Venue :Fremont, CA, United States

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Overview: The Food and Drug Administration Modernization Act (FDAMA) requires that manufacturers track certain devices when the agency orders them to do so. Tracking is intended to facilitate notification and recall in the event a device presents a serious risk to health that requires prompt attention. The tracking provisions enacted by SMDA required mandatory tracking even if FDA did not issue an order. Specifically, section 519(e), as added by SMDA, required manufacturers to track if they were registered with FDA under section 510 of the act and engaged in the manufacturer of a device if its failure.

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