FDA issues proposed rule to allow use of stand-alone symbols on medical device labels *

USA - May 7 2013
The FDA recently issued a proposed rule to allow the use of stand-alone symbols (i.e., not adjacent to a text explanation) on the labels of medical…

Co-authors: Lynn C. Tyler, M.S..

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Conflicting developments on timing of new food safety rules *

USA - April 30 2013
In January 2011, President Obama signed the Food Safety Modernization Act (FSMA) which included, among many other provisions, a requirement for the…

Co-authors: Lynn C. Tyler, M.S., William W. Wales, Joe R. Thompson.

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FDA Issues draft guidance on distinguishing medical device recalls from product enhancements *

USA - April 23 2013
The FDA recently issued a draft guidance on how to distinguish a medical device recall from a product enhancement. The draft guidance also discusses…

Co-authors: Lynn C. Tyler, M.S..

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Media reporting impostors posing as FDA inspectors *

USA - April 17 2013
As happens from time to time, recently various news media have reported that companies claim to have been visited by fraudulent FDA inspectors, i.e…

Co-authors: Lynn C. Tyler, M.S..

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FDA issues proposed rule on acceptance of data from clinical studies on medical devices *

USA - February 28 2013
Earlier this week, the Food and Drug Administration (FDA) issued a proposed rule amending its regulations on the acceptance of data from clinical…

Co-authors: Lynn C. Tyler, M.S..

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