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Title: Administration of the Radiation Control for Health and Safety Act of 1968, Public Law 90-602, (1987 annual report). Report for January-December 1987

Technical Report ·
OSTI ID:7052425

This document is an annual report submitted to the President for transmittal to the Congress. The Food and Drug Administration, through its Center for Devices and Radiological Health, is responsible for the day-to-day administration of the Radiation Control for Health and Safety Act of 1968. The report provides a summary of the operations of the Center in carrying out that responsibility for calendar year 1987. In reviewing the operations of the CDRH as reported in the document, it should be kept in mind that the day-to-day administration of the Act is only part of the Center's function. Other responsibilities include the administration and enforcement of the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (not covered in the report). Manufacturers of electronic products are required by 21 CFR 1002.20 to report accidental radiation occurrences to the CDRH. The Center no longer maintains a Radiation Incidents Registry, since accidental radiation occurrences are reported through the Device Experience Network (DEN) and through the requirements of the Medical Device Reporting (MDR) regulations.

Research Organization:
Food and Drug Administration, Rockville, MD (USA). Center for Devices and Radiological Health
OSTI ID:
7052425
Report Number(s):
PB-88-241567/XAB; FDA/CDRH-88/41
Resource Relation:
Other Information: See also PB--87-215828
Country of Publication:
United States
Language:
English