[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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