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Statement from FDA Commissioner Scott Gottlieb on new policy steps for strengthening public warning and notification of recalls

Press releases may be edited for formatting or style | January 19, 2018 Medical Devices

Making sure the FDA has effective recall practices in place, and that we take immediate action to address unsafe products, are high priorities of mine. Our recall authorities – and how we deploy them – are a cornerstone of our vital, consumer protection mission and I take these obligations very seriously.

The draft guidance issued today is just the first in a series of policy steps we’ll take this year as part of a broader action plan to further improve our oversight of food safety and how we help implement the recall process.

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We all know that hazardous recalled products can have a devastating impact on human lives. We’re committed to making sure that recalls are initiated, overseen, and completed promptly and effectively to best protect consumers; and we will use all the tools at our disposal to carry through on this commitment.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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