The webinar clarifies the regulatory concern that FDA has and whether subjecting Laboratory Developed Tests (LDTs) to FDA's device Quality System Regulation can make a measurable difference in the safety and effectiveness (reliability) of special IVDs. The arguments on both sides of the issue will be identified and how regulation may adversely impact the quality of health care we have today. The presumption by FDA is that regulation will improve these special IVDs and, thereby, improve the quality of health care.

Date : 10th March 2015 to 10th March 2015

Place : United States, Fremont

Website :http://bit.ly/1BRTmy1

Contact Person:Adam Fleaming

Description:

The webinar clarifies the regulatory concern that FDA has and whether subjecting Laboratory Developed Tests (LDTs) to FDA's device Quality System Regulation can make a measurable difference in the safety and effectiveness (reliability) of special IVDs. The arguments on both sides of the issue will be identified and how regulation may adversely impact the quality of health care we have today. The presumption by FDA is that regulation will improve these special IVDs and, thereby, improve the quality of health care.

The webinar clarifies the regulatory concern that FDA has and whether subjecting Laboratory Developed Tests (LDTs) to FDA's device Quality System Regulation can make a measurable difference in the safety and effectiveness (reliability) of special IVDs. The arguments on both sides of the issue will be identified and how regulation may adversely impact the quality of health care we have today. The presumption by FDA is that regulation will improve these special IVDs and, thereby, improve the quality of health care. will be held in Fremont,United States on date 2015-03-10

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Deadline for abstracts/proposals : 9th March 2015

Keynote Speakers :

Check the event website for more details.