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Regulation

FDA’s Review of the 510(k) Process

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The Food and Drug Administration has been reviewing its 510(k) process, which is used for many medical device approvals. Two preliminary reports contain a series of recommendations designed to provide greater predictability in the process, while ensuring identification of significant safety concerns.

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GAO Report on Genetic Testing

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Personalized medicine relies on genetic testing for much of its information. Direct-to-consumer genetic testing firms are widespread and a GAO report reveals that much of their work appears shoddy and their marketing deceptive. More regulation appears needed and on the way.

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