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DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION Form Approved: OMB No. 0910-0387 Expiration Date: March 31, 2005, VALIDATION 1. REGISTRATION NO. Print Clear Form INITIAL REGISTRATION
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What is initial registration of device?
Initial registration of device is the process of registering a device with the appropriate regulatory authority before it can be legally sold or distributed.
Who is required to file initial registration of device?
Manufacturers, distributors, and importers of devices are required to file the initial registration of device.
How to fill out initial registration of device?
To fill out the initial registration of device, you need to complete the required forms and provide all the necessary information about the device, its manufacturer, and its intended use.
What is the purpose of initial registration of device?
The purpose of the initial registration of device is to ensure that all devices on the market meet the necessary safety and performance standards, and to track and monitor their distribution.
What information must be reported on initial registration of device?
The information that must be reported on the initial registration of device includes details about the device's manufacturer, such as their name and contact information, as well as information about the device itself, such as its intended use and any relevant safety certifications or testing.
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