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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…

Hae Park-Suk

FDA Issues draft guidance on distinguishing medical device recalls from product enhancements

USA - April 23 2013 The FDA recently issued a draft guidance on how to distinguish a medical device recall from a product enhancement. The draft guidance also discusses…

Hae Park-Suk

FDA issues guidance on use of nanotechnology in foods

USA - June 30 2014 The FDA recently issued a final guidance titled, "Guidance for Industry: Assessing the Effects of Significant Manufacturing Process Changes…

Philip J. Faccenda, Jr., Glenn E. Killoren, Hae Park-Suk, Todd G. Vare

FDA declines courts’ requests to define “natural” with respect to GMO foods

USA - January 10 2014 The FDA recently issued a letter to three federal district court judges declining the courts' requests to adopt a definition of "natural" or to state…

Olivia Fleming, Joan L. Long, Hae Park-Suk

FDA Issues Discussion Paper on Artificial Intelligence and Machine Learning in Medical Devices

USA - May 29 2019 The FDA recently issued a discussion paper and request for feedback titled, “Proposed Regulatory Framework for Modifications to Artificial…