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Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA seeking more time to reassess new rule on medical device use

Press releases may be edited for formatting or style | January 15, 2018 Medical Devices

We’re also making sure that the tobacco-related portions of the final rule will go into effect. So we’ve decoupled the intended use language from the tobacco part of the rule. We remain committed to rulemaking on the subject of intended use, and to an open and public process regarding the substance of the rule. In order to allow time to review comments received on the proposal to delay the March 19, 2018 effective date of the portion of the rule that related to intended use, and to prepare and publish a final rule effectuating the proposed delay, the agency has opened a comment period that will remain open until February 5, 2018.

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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