To make submissions to FDA (e.g., Establishment Registration, Product Listing and Self-ID, etc.) you must first create an account. Click here to create a new account.. If you already have an account, enter your Username and Password.. WARNING: This warning banner provides privacy and security notices consistent with applicable federal laws, directives, and other federal guidance for accessing ...
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.
Blood Establishment Registration Tissue Establishment Registration Biological Product Deviation Reporting (Form FDA 3486) New CBER On-Line Users New users must first create an account. Create a New Account. Existing account holders may login by entering your user name and password below.
This database includes: medical device manufacturers registered with FDA and; medical devices listed with FDA; Note: Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by FDA.
FDA Industry Systems. Login / Create Account. The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 ... FDA may by order suspend the registration of â¦
Registration and listing provides FDA with the location of medical device establishments and the devices manufactured at those establishments. Knowing where devices are made increases the nation ...