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| HHS/FDA | RIN: 0910-AC34 | Publication ID: Fall 2004 |
| Title: Amendments to the Performance Standard for Diagnostic X-Ray Systems and Their Major Components | |
| Abstract: This rule amends the performance standard for diagnostic x-ray systems and their components in 21 CFR 1020.30, 1020.31, 1020.32, and 1020.33 to address the changes in technology and practice. | |
| Agency: Department of Health and Human Services(HHS) | Priority: Economically Significant |
| RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
| Major: Yes | Unfunded Mandates: No |
| CFR Citation: 21 CFR 1020.30; 21 CFR 1020.31; 21 CFR 1020.32; 21 CFR 1020.33 | |
| Legal Authority: 21 USC 351; 21 USC 352; 21 USC 360e to 360j; 21 USC 360hh to 360ss; 21 USC 371; 21 USC 381 | |
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Legal Deadline:
None |
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Timetable:
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| Regulatory Flexibility Analysis Required: Yes | Government Levels Affected: None |
| Small Entities Affected: Businesses | Federalism: No |
| Included in the Regulatory Plan: No | |
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Agency Contact: Joseph M. Sheehan Chief, Regulations Staff Department of Health and Human Services Food and Drug Administration HFZ-215, Center for Devices and Radiological Health, HFZ-215, 1350 Piccard Drive, Rockville, MD 20850 Phone:301 827-2974 Fax:301 594-4765 Email: joseph.sheehan@fda.hhs.gov |
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