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Title: Annual report on the administration of the Radiation Control for health and Safety Act of 1968, Public Law 90-602, April 1, 1991. Rept. for Jan-Dec 90

Technical Report ·
OSTI ID:6161371

The Secretary of Health and Human Services is required by Subpart 3, Part F of Title III of the Public Health Service Act; 42 USC 263b et seq. (Public Law 90-602) to submit an annual report to the President for transmittal to the Congress on or before April 1 on the administration of the Radiation Control for Health and Safety Act. The detailed information required in the report is outlined in Section 360D of the Public Health Service Act. 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 1990. In reviewing the operations of the Center for Devices and Radiological Health 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 Center for Devices and Radiological Health. 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 (United States). Center for Devices and Radiological Health
OSTI ID:
6161371
Report Number(s):
PB-91-238568/XAB; FDA/CDRH-91/33
Resource Relation:
Other Information: See also report for 1990, PB90-260589
Country of Publication:
United States
Language:
English