[Federal Register Volume 62, Number 238 (Thursday, December 11, 1997)]
[Proposed Rules]
[Pages 65235-65237]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-32462]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1020

[Docket No. 97N-0427]
RIN 0910-ZA06


Diagnostic X-Ray Equipment Performance Standard; Request for 
Comments and Information

AGENCY: Food and Drug Administration, HHS.

ACTION: Advance notice of proposed rulemaking.

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SUMMARY: The Food and Drug Administration (FDA) is announcing its 
intention to propose amendments to the performance standard for 
diagnostic x-ray systems and their major components. The agency is 
taking this action to address changes in the technology and use of 
radiographic and fluoroscopic systems. The agency is issuing this 
advance notice of proposed rulemaking (ANPRM) in accordance with its 
policy of early public disclosure of rulemaking activities. The FDA is

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soliciting comments and information from interested persons concerning 
the subject matter of the proposed amendments.

DATES: Submit written comments on the proposed amendments by March 11, 
1998.
ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the summary of concepts for amendments and a 
summary of the April 8 through 9, 1997, meeting of the Technical 
Electronic Product Radiation Safety Standards Committee (TEPRSSC). 
Submit written requests for single copies of the Diagnostic X-Ray 
Equipment Performance Standard to the Division of Small Manufacturers 
Assistance (DSMA), Center for Devices and Radiological Health (HFZ-
220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 
20850. Send two self-addressed adhesive labels to assist that office in 
processing your request or fax your request to 301-443-8818.

FOR FURTHER INFORMATION CONTACT:  Thomas B. Shope, Center for Devices 
and Radiological Health (HFZ-140), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-443-3314, ext. 32.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA, under authority conferred by the Public Health Service Act as 
amended by the Radiation Control for Health and Safety Act (RCHSA) of 
1968 (Pub. L. 90-602 (21 U.S.C. 360hh-360ss)), administers an 
electronic product radiation control program to protect the public 
health and safety. This authority provides for the development and 
administration of radiation safety performance standards for electronic 
products.
    In order for mandatory performance standards to achieve intended 
public health protection, attention must be given to keeping the 
requirements of standards updated and appropriate. A number of 
technological developments have been or will be implemented for 
radiographic and fluoroscopic x-ray systems that are not addressed by 
the performance standard or that present problems in the application of 
the requirements of the current standard. FDA is developing proposed 
amendments to the performance standard for radiographic and 
fluoroscopic systems that take into account new technology, clarify 
certain provisions, and address additional requirements that may be 
determined to be necessary to provide for adequate radiation safety of 
these systems.
    On October 16 and 17, 1992, the American College of Radiology and 
FDA sponsored a workshop on fluoroscopy to develop strategies for 
improvement in performance, safety and control of fluoroscopic 
equipment. Physicians, physicists, State and Federal government 
regulators, and fluoroscopic equipment manufacturers attended the 
workshop. They discussed and made recommendations for different ways to 
approach fluoroscopic radiation safety issues and concerns, including 
regulatory solutions.
    In the Federal Register of May 19, 1994 (59 FR 26402), FDA 
published a final rule effective May 19, 1995, amending performance 
requirements for fluoroscopic systems to address the immediate concern 
of preventing unlimited exposure rates during the high-level control 
mode of fluoroscopic system operation. The TEPRSSC discussed the status 
of standards for fluoroscopic systems and new clinical uses during a 
meeting held on April 9 through 10, 1996. TEPRSSC is a permanent 
statutory advisory committee established by statute that FDA must 
consult prior to issuing standards under the RCHSA.
    At a meeting of the TEPRSSC held on April 8 through 9, 1997, FDA 
presented general concepts for amendments to the performance standard 
for radiographic and fluoroscopic systems.
    The committee recommended that FDA pursue development of the 
amendments in the areas discussed in section II of this notice.
    A transcript of the TEPRSSC April 8 through 9, 1997, meeting may be 
ordered from Miller Reporting Co., Inc., 507 C St. NE., Washington, DC 
20002, 202-546-6666 or FAX 202-546-1502.
    Individuals or organizations wishing to receive copies of draft 
amendments or related documents distributed for review during the 
development of these amendments may have their names placed on the 
mailing list by writing to: Office of Science and Technology (HFZ-140), 
Center for Devices and Radiological Health, Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, FAX 301-443-
9101, e-mail: [email protected].

II. Concepts for Amendments to the Standard

    FDA has identified the following nine areas as candidates for 
amendments to accommodate changes in technology and clinical use of 
radiographic and fluoroscopic systems. The discussion below each 
concept is not intended to indicate the specific content of the 
proposed amendment to be developed, but is meant only to describe the 
need and FDA's proposed approach. The specific regulatory changes or 
proposed standards will be included in a future proposed rule. Comments 
received in response to this notice will be used to develop the 
proposed amendments. FDA requests comments on the following conceptual 
changes:
    1. Conversion to the International System of Units (SI) quantities 
and units for the entire standard. This proposal is to amend all 
sections of the performance standard for diagnostic x-ray systems to 
use the radiation quantity ``air kerma'' in place of the quantity 
``exposure'' and to change the units to the SI.
    2. Clarification of applicability of requirements to technological 
developments, such as digital imaging, digital recording and solid-
state x-ray imagers. The current organization and structure of the 
standard assumes the presence of an x-ray image intensifier as the 
basis for many of the requirements for fluoroscopic systems. This 
assumption may be inappropriate for digital fluoroscopy systems that 
may use new types of digital image receptors. Such systems may not have 
an image intensifier tube. The structure of the radiographic section of 
the standard is based on radiographic film as the image receptor and 
revisions are needed to incorporate technological developments in that 
area. It would be desirable to the extent possible to use terminology 
consistent with usage adopted by the International Electrotechnical 
Commission (IEC).
    3. Amendment to incorporate draft Compliance Policy Guide on 
Information to be Provided to Users (21 CFR 1020.30(h)). This proposal 
would amend the requirements on the content of information that must be 
provided to users to include specific information on the air kerma rate 
for certain fluoroscopic modes of operation. This amendment would 
incorporate into the standard a draft Compliance Policy Guide that has 
been developed, but not yet issued, and is intended to interpret 
Sec. 1020.30(h) for certain ``unique'' modes of fluoroscopic system 
operation.
    4. Amendment to add requirements for minimum half-value layer (HVL) 
for systems designed for interventional radiology (Sec. 1020.30(m)). 
This proposal would increase the minimum half-value layer requirements 
for fluoroscopic systems designed for interventional radiology. Such a 
requirement will require definition of a ``fluoroscopic system designed 
for interventional

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fluoroscopy.'' As a concept for discussion, fluoroscopic systems 
designed for interventional radiology might be defined as systems that 
permit the beam axis to be positioned at an angle relative to the 
normal to the table top. Systems in which the x-ray beam direction is 
fixed with respect to the plane of the tabletop, such as conventional 
radiographic/ fluoroscopic systems, would not be included in this 
definition.
    5. Amendment to require improved x-ray field limitation (21 CFR 
1020.32(b)(2)(v)). This proposal would require improved limitation of 
the x-ray field for fluoroscopic equipment to match the actual area of 
the image receptor being used for image capture, thereby reducing the 
amount of non-useful beam striking the patient.
    6. Amendment to clarify the requirements for the minimum source-
skin distance for small, mobile, or portable mini C-arm systems 
(Sec. 1020.32(g)). This amendment would address numerous requested and 
granted variances for fluoroscopic systems that have limited source-
image receptor distances. The amendment would specify the conditions 
under which a shorter-than-standard source-skin distance is permitted 
and would obviate the need for continued variances from the standard.
    7. Amendment to require indication of cumulative exposure time on 
fluoroscopic systems (Sec. 1020.32(h)). The proposed amendment would 
require the means to indicate the cumulative time of fluoroscopic 
irradiation of a patient during an examination or procedure.
    8. Amendment to require provision of ``last-image-hold'' feature on 
fluoroscopic systems (Sec. 1020.32(j)). This amendment would require 
that all fluoroscopic x-ray systems be provided with a means to 
continuously display the last image acquired following termination of 
any exposure period.
    9. Amendment to require indication of air kerma rate and cumulative 
air kerma on fluoroscopic systems (Sec. 1020.32(k)). The proposed 
amendment would require the means to display to the fluoroscopist at 
the fluoroscopist's working position the cumulative air kerma and the 
air kerma rate (air kerma per unit time) at which air kerma accrues 
during irradiation of a patient in an examination or procedure.

III. Electronic Access

    The summary of concepts for amendments entitled ``Concepts for 
Proposed Amendments to the Performance Standard for Diagnostic X-ray 
Systems, August 1, 1997,'' may be accessed at the CDRH Home Page on the 
World Wide Web. It is available on the Topic Index page at: http://
www.fda.gov/cdrh/topindx under ``Fluoroscopy''. A text-only version of 
the CDRH site is also available from a computer or VT-100 compatible 
terminal by dialing 800-222-0185 (terminal settings are 8/1/N). Once 
the modem answers, press Enter several times and then select menu 
choice 1: FDA BULLETIN BOARD SERVICE. From there, follow instructions 
for logging in, and at the BBS TOPICS PAGE, arrow down to the FDA Home 
Page (do not select the first CDRH entry). Then select Medical Devices 
and Radiological Health. From there, select CENTER FOR DEVICES AND 
RADIOLOGICAL HEALTH for general information, or arrow down for specific 
topics.
    The document may also be obtained by fax by calling the CDRH Facts-
On-Demand (FOD) system at 800-899-0381 or 301-827-0111 from a touch-
tone telephone. At the first voice prompt press 1 to access DSMA Facts, 
at the second voice prompt press 2, and then enter the document number 
591 followed by the pound sign (#). Then follow the remaining voice 
prompts to complete your request.
    A summary of the TEPRSSC April 8 through 9, 1997, meeting is 
available on the CDRH Home Page at the same address given above for the 
concepts for amendments document.

IV. Comments

    Interested persons may, on or before March 11, 1998, submit to the 
Dockets Management Branch (address above) written comments regarding 
this proposed amendment. Two copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. Received comments may be seen in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
    Interested persons also are invited to participate in the 
development of proposed amendments by submitting written data, views, 
or arguments concerning the subject matter of the amendments, or 
related topics suggested for inclusion in the amendments. In addition 
to general comments and recommendations, respondents are encouraged to 
include suggested text for provisions of the proposed amendments that 
reflect their recommended performance requirements. A statement of 
rationale should accompany any such proposed text. When a determination 
is made on the content of the proposed amendments, they will be 
published as notices of proposed rulemaking with opportunity given for 
public comment. Information and comments are specifically invited on 
the following topics:
    1. For concepts 4 through 9 in section II of this document, 
recommendation for whether the amendments should be limited only to 
equipment designed for interventional procedures or for all 
fluoroscopic systems. If only for interventional systems, how should 
``interventional fluoroscopic systems'' be defined?
    2. The desirability and technical feasibility of amendments of the 
type described in section II of this document.
    3. Recommended performance requirements to be included in the 
proposed amendments, including attendant methods and conditions of 
measurement.
    4. Suggestions and supporting data for other amendments to the 
performance standard for radiographic or fluoroscopic equipment, 
including moving towards more outcome-based performance standards, 
which may be needed to provide for adequate radiation safety.
    5. The possible environmental impact of this action, including 
factors such as radiation exposure reduction or prevention and economic 
consequences in relation to expected benefits (cost-benefit 
relationship), and the anticipated costs of providing such features or 
meeting the requirements.
    6. Any additional terms or definitions that are needed to better 
specify the intent or meaning of the regulations as they apply to the 
equipment.
    This ANPRM is issued under 21 U.S.C. 321 and under the authority of 
the Commissioner of Food and Drugs.

    Dated: October 29, 1997.
 William K. Hubbard,
 Associate Commissioner for Policy Coordination.
[FR Doc. 97-32462 Filed 12-10-97; 8:45 am]
BILLING CODE 4160-01-F