United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2005_register executive 2011-05-10 article Part III Rules and Regulations D09002ee1c81155ce D09002ee1c81156bd United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA) is issuing a final rule to amend the Federal performance standard for diagnostic x-ray systems and their major components (the performance standard). The agency is taking this action to update the performance standard to account for changes in technology and use of radiographic and fluoroscopic x-ray systems and to fully utilize the International System of Units to describe radiation-related quantities and their units when used in the performance standard. For clarity and ease of understanding, FDA is republishing the complete contents, as amended, of three sections of the performance standard regulations and is amending a fourth section without republishing it in its entirety. 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). 70 FR 33998 https://www.govinfo.gov/app/details/FR-2005-06-10/05-11480 05-11480 fr10jn05-18 RIN 0910-AC34 4160-01-S Docket No. 2001N-0275 https://www.govinfo.gov/app/details/FR-2005-06-10/05-11480 https://www.govinfo.gov/content/pkg/FR-2005-06-10/html/05-11480.htm https://www.govinfo.gov/content/pkg/FR-2005-06-10/pdf/05-11480.pdf 45 p. 33998 34042 70 FR 33998 Title 21 Part 1020 21 CFR Part 1020 RIN 0910-AC34 Electronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components; Federal Register Vol. 70, Issue RULE 05-11480 III DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2006-06-10 Docket No. 2001N-0275 4160-01-S 05-11480 Final rule.

The Food and Drug Administration (FDA) is issuing a final rule to amend the Federal performance standard for diagnostic x-ray systems and their major components (the performance standard). The agency is taking this action to update the performance standard to account for changes in technology and use of radiographic and fluoroscopic x-ray systems and to fully utilize the International System of Units to describe radiation-related quantities and their units when used in the performance standard. For clarity and ease of understanding, FDA is republishing the complete contents, as amended, of three sections of the performance standard regulations and is amending a fourth section without republishing it in its entirety. 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).

This rule is effective June 10, 2006. 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. Radiologic health: Diagnostic x-ray systems and their major components; performance standard, http://www.ahrq.gov/data/hcup/ http://www.fda.gov http://www.fda.gov/cdrh/radhealth/fluoro/amendxrad.pdf http://www.fda.gov/cdrh/radhlth/021501_xray.html http://www.fda.gov/cdrh/radhlth/scifor01f.pdf Vol. 70, no. 111 Office of the Federal Register, National Archives and Records Administration 2005-06-10 continuing daily deposited born digital 269 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2005-06-10 P0b002ee180cfc06f 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr10jn05 https://www.govinfo.gov/app/details/FR-2005-06-10 https://www.govinfo.gov/content/pkg/FR-2005-06-10/pdf/FR-2005-06-10.pdf https://www.govinfo.gov/content/pkg/FR-2005-06-10/xml/FR-2005-06-10.xml fdlp 33797 34054 DGPO 2011-05-10 2024-06-06 FR-2005-06-10 machine generated eng FR FR-2005-06-10 70 111