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ACTION: Originate: 06/06/2005 10:08 Ampule Summary and Fiscal Analysis (Part A) Department of Job and Family Services Agency NameDivision of Medical Assistance Nancy Van KirkDivisionContact30 E. Broad

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Any individual or entity seeking authorization under the 21 USC 379j regulations would need the 21 USC 379j authority.

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What is 21 usc 379j authority?

21 USC 379j refers to the authority under the Federal Food, Drug, and Cosmetic Act that governs the requirements for the registration and listing of medical devices and the submission of premarket notification or premarket approval to the FDA.

Who is required to file 21 usc 379j authority?

Manufacturers and importers of medical devices are required to file under 21 USC 379j to ensure that their products are properly registered and compliant with FDA regulations.

How to fill out 21 usc 379j authority?

To fill out the 21 USC 379j authority, manufacturers and importers must complete the necessary FDA forms, providing detailed information about their medical devices, including technical specifications, intended use, and any clinical data required.

What is the purpose of 21 usc 379j authority?

The purpose of 21 USC 379j authority is to ensure the safety and effectiveness of medical devices by requiring manufacturers to register their products and submit required documentation to the FDA for review.

What information must be reported on 21 usc 379j authority?

Information that must be reported includes the device name, manufacturer details, intended use, labeling, and any clinical or safety data that supports the device's marketing authorization.

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