[Federal Register Volume 67, Number 197 (Thursday, October 10, 2002)]
[Notices]
[Page 63108]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-25881]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 02D-0407]
Diagnostic X-Ray Field Size; Revocation of Compliance Policy
Guide 7133.17
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is revoking the
Compliance Policy Guide (CPG) entitled ``Sec. 398.475 Minimum X-Ray
Field Size for Spot-Film Operation of Fluoroscopic Systems with Fixed
SID and Without Stepless Adjustment of the Field Size (CPG 7133.17).''
This CPG is no longer necessary because the agency amended the
Diagnostic X-Ray Systems Federal Performance Standard to include the
minimum x-ray field size.
DATES: The revocation is effective November 12, 2002.
ADDRESSES: Submit written requests for single copies of the CPG to the
Division of Compliance Policy (HFC-230), Office of Enforcement, Office
of Regulatory Affairs, Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-0411, or FAX your request to 301-827-0482.
A copy of the CPG may be seen in the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Jeffrey B. Governale, Division of
Compliance Policy (HFC-230), Office of Enforcement, Office of
Regulatory Affairs, Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-0411.
SUPPLEMENTARY INFORMATION:
I. Background
FDA issued the CPG entitled ``Sec. 398.475 Minimum X-Ray Field Size
for Spot-Film Operation of Fluoroscopic Systems with Fixed SID and
Without Stepless Adjustment of the Field Size (CPG 7133.17)'' on
October 1, 1980. This CPG addresses the different requirements for
minimum field size for spot-film and fluoroscopic modes of operation
for fixed source-image receptor distance (SID) fluoroscopic x-ray
systems. This CPG includes a statement that such systems that do not
have stepless adjustment would be required to provide a minimum field
size of 125 square centimeters or less during fluoroscopy and spot-film
radiography.
In the Federal Register of May 3, 1993 (58 FR 26401), FDA amended
the diagnostic X-ray systems Federal performance standard to
incorporate a provision for spot-film devices used on fixed SID
fluoroscopic systems. Specifically, 21 CFR 1020.31(h)(4)(i) requires
that for spot-film devices used on fixed SID fluoroscopic systems which
are not required to, and do not provide stepless adjustment of the x-
ray field, the minimum field size, at the greatest SID, does not exceed
125 square centimeters.
Given the current diagnostic X-ray systems Federal performance
standard, FDA is revoking CPG 7133.17, in its entirety, to eliminate
unnecessary compliance policy.
II. Electronic Access
Before November 12, 2002, a copy of the CPG may be obtained from
the Internet at http://www.fda.gov/ora/compliance--ref/cpg/cpgdev/
cpg398-475.html.
Dated: October 1, 2022.
John Marzilli,
Deputy Associate Commissioner for Regulatory Affairs.
[FR Doc. 02-25881 Filed 10-9-02; 8:45 am]
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