Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment: Draft Guidance for Industry and Food and Drug Administration Staff

Information

Type

Guidance

Regulated products

Medical Devices

Topics

Export, Import, Labeling

Published

December 17, 2018

Last updated

April 26, 2021

Description

This document is a draft guidance for manufacturers of diagnostic X-ray equipment, providing clarification on radiation control regulations. Topics covered include export, import, and labeling.

Organization

Country / Region

United States

License

Other (Public Domain)

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