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United States
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Regulatory Information
2002_register
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2010-09-23
article
Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components
Part VII
Proposed Rules
D09002ee1bdeccdb5
D09002ee1bdecce35
United States
Department of Health and Human Services
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org
United States Government Agency or Subagency
United States
Food and Drug Administration
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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA) is proposing to amend the performance standard for diagnostic x-ray systems and their major components. The agency is taking this action to update the standard to account for changes in technology and use of radiographic and fluoroscopic systems as well as to fully utilize the currently accepted metric system of units in the standard. For clarity and ease of understanding, FDA is republishing the complete contents of the affected regulations. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical Devices Act of 1990 (SMDA).
67 FR 76056
https://www.govinfo.gov/app/details/FR-2002-12-10/02-30550
02-30550
fr10de02-19
RIN 0910-AC34
4160-01-S
Docket No. 01N-0275
https://www.govinfo.gov/app/details/FR-2002-12-10/02-30550
https://www.govinfo.gov/content/pkg/FR-2002-12-10/html/02-30550.htm
https://www.govinfo.gov/content/pkg/FR-2002-12-10/pdf/02-30550.pdf
39 p.
76056
76094
67 FR 76056
Code of Federal Regulations
Title 21 Part 1020
21 CFR Part 1020
Regulation Identification Number 0910-AC34
RIN 0910-AC34
Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components; Federal Register Vol. 67, Issue
PRORULE
02-30550
VII
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2003-04-09
Docket No. 01N-0275
4160-01-S
02-30550
Proposed rule.
The Food and Drug Administration (FDA) is proposing to amend the performance standard for diagnostic x-ray systems and their major components. The agency is taking this action to update the standard to account for changes in technology and use of radiographic and fluoroscopic systems as well as to fully utilize the currently accepted metric system of units in the standard. For clarity and ease of understanding, FDA is republishing the complete contents of the affected regulations. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Safe Medical Devices Act of 1990 (SMDA).
Submit written or electronic comments by April 9, 2003. See section III of this document for the proposed effective date of a final rule based on this document. Submit written comments on the information collection requirements by January 9, 2003.
Thomas B. Shope, Center for Devices and Radiological Health (HFZ-140), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-443-3314, ext. 132.
Radiological health:
Diagnostic x-ray systems and their major components; performance standard,
http://www.fda.gov
http://www.fda.gov/cdrh/radhealth/fluoro/amendxrad.html
http://www.fda.gov/cdrh/radhlth/021501
http://www.fda.gov/cdrh/radhlth/021501_xray.html
http://www.fda.gov/dockets/ecomments
Federal Register
Vol. 67, no. 237
Office of the Federal Register, National Archives and Records Administration
2002-12-10
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310 p.
Table of Contents:
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AE 2.106:
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https://www.govinfo.gov/app/details/FR-2002-12-10
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https://www.govinfo.gov/app/details/FR-2002-12-10
https://www.govinfo.gov/content/pkg/FR-2002-12-10/pdf/FR-2002-12-10.pdf
https://www.govinfo.gov/content/pkg/FR-2002-12-10/xml/FR-2002-12-10.xml
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2010-09-23
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FR-2002-12-10
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FR-2002-12-10
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