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Latest News | 26 March 2012

Congressman Calls for Closure of Medical Device ‘Loophole’ in Report

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Massachusetts Democrat Edward Markey is calling for the stricter regulation of medical devices and the closure of a so-called “loophole” in the US Food and Drug Administration’s (FDA) 510(k) pathway [Read More...]

Tags: Loophole Markey Medical Device report SOUND Act Sound Devices Act
Latest News | 28 February 2012

Shuren: Predicate Device ‘Loophole’ Must Be Closed

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The head of the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) is calling for the end to a so-called "loophole" in the 510(k) medical device approval [Read More...]

Tags: 510(k) CDRH FDA HR 3847 Jeffery Shuren Medical Device Predicate Safety Shuren Sound Devices Act Substantially Equivalent
Latest News | 3 February 2012

Duo of US Bills Aim to Prevent Drug Shortages, Amend 510(k) Pathway

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Representatives John Carney (D-DE) and Ed Markey (D-MA) both introduced bills this week that would, respectively, aim to prevent drug shortages and grant the US Food and Drug Administration (FDA) the [Read More...]

Tags: Act Bill Congress DeLauro Drug Shortages Prevention Act FDA Markey Markey medical devices Schakowsky Senate Shortages Sound Devices Act Waxman