Premarket Review

The examination of data and information in an application for premarket review described in sections 505, 510(k), 513(f), 515, or 520(g) or 520(l) of… (More)
National Institutes of Health

Papers overview

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Review
2016
Review
2016
Among other key objectives, the 2009 Family Smoking Prevention and Tobacco Control Act was designed to end an era of constant… (More)
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Review
2016
Review
2016
Until the enactment of the Family Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Control Act or TCA), the tobacco… (More)
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Review
2015
Review
2015
In October 2014, the US Food and Drug Administration (FDA) announced a proposed new framework to extend their regulatory… (More)
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Review
2014
Review
2014
The Food and Drug Administration (FDA)'s 510(k) program based upon substantial equivalence review is by far the dominant pathway… (More)
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2013
2013
A dietary supplement marketed as a weight loss and bodybuilding aid has been linked to dozens of cases of acute hepatitis and at… (More)
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Review
2011
Review
2011
Through its premarket regulation of medical devices, FDA aims to secure device safety and effectiveness while allowing for device… (More)
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Review
2001
Review
2001
The United States Food and Drug Administration (FDA) has announced its intention to launch an extraordinary new pilot programme… (More)
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Review
1999
Review
1999
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  • 1999
The Food and Drug Administration (FDA) is issuing a final rule to require the filing of a premarket approval application (PMA) or… (More)
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Review
1998
Review
1998
"This is an exciting time," says Eric Rechen, policy analyst in the U.S. Food and Drug Administration's (FDA) Office of Device… (More)
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Review
1998
Review
1998
"The FDA has long advocated the use of standards as a significant contributor to safety and effectiveness of medical devices… (More)
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