Issue Date: March 1, 1989
Issued by: Center for Devices and Radiological Health
Topic(s): Radiology
Status: Final
Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 1 )
This publication includes all current FDA Compliance Policy Guides pertaining to the Performance Standard, interpretations of the Performance Standard in either narrative or question-and-answer form, and interpretive letters that have been sent to the industry. Manufacturers are reminded that they must also meet pertinent requirements of the Medical Device Amendments, which are not addressed in this document.
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