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Featured. FDA Takes Action to Address Coronavirus Disease 2019 (COVID-19) FDA is working with U.S. Government partners, including CDC, and international partners to address the outbreak.

FDA Industry Systems (FIS) was created to facilitate making submissions to the U.S. Food and Drug Administration (FDA), including registrations, listings, and other notifications. FIS has been available 24 hours a day, seven days a week, since October 16, 2003 6:00 p.m. EDT.

FDA Industry Systems Account Management Login to FDA Industry Systems - Step-by-Step Instructions. ... An official website of the United States government Here’s how you know .

Before using FDA's Direct system, FDA strongly encourages you to have current antivirus and antispyware software installed on your computer to help ensure the privacy of the information being entered. Browser Compatibility: The CDER Direct portal currently works best with the following browsers: Microsoft Internet Explorer 8 (IE8) and above

Warning: You are accessing a U.S. Government information system.The system usage may be monitored, recorded, and subject to audit. Unauthorized use of the system is prohibited and subject to criminal and civil penalties.

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PN_0010:You are using an unsupported browser. Please refer to the Computer System Requirements for Web Browsers on the FDA Industry Systems page (www.access.fda.gov).

FDA regulates the sale of medical device products in the U.S. and monitors the safety of all regulated medical products. ... An official website of the United States government Here’s how you know .