Search Results for FDA proposed rule

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FDA Looks to Decrease Adverse Events With New Home-Use Device Label Database By Zachary Brennan - Published 25 October 2016

As part of efforts to reduce an increasing number of adverse events from home-use medical devices, FDA is proposing to create an online database of all such device labels and to require companies to submit the labels and package inserts in an electronic format.

Categories: News, US, FDA, Labeling, Medical Devices, Product withdrawl and retirement, Regulatory intelligence, Regulatory strategy

Tags: home-use medical devices, new FDA proposed rule, FDA rules

How an FDA Proposed Rule for Tobacco Products Could Have a Big Impact on 'Intended Uses' for Devices, Drugs By Zachary Brennan - Published 19 October 2015

Late last month, the US Food and Drug Administration (FDA) unveiled a new proposed rule that many in the pharmaceutical and medical device regulatory communities may have glanced over without a thought because it seemed to pertain only to tobacco products. But on a second look, the rule, if finalized, could have a major impact on the intended use regulations for drugs and devices.

Categories: Drugs, Due Diligence, Ethics, Government affairs, Labeling, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: intended use, medical device, regulatory, drug, FDA proposed rule