[Federal Register Volume 59, Number 148 (Wednesday, August 3, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-18799]
[[Page Unknown]]
[Federal Register: August 3, 1994]
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FEDERAL COMMUNICATION COMMISSION
47 CFR Part 18
[ET Docket No. 92-255; FCC 94-155]
Removal of Unnecessary Regulations Regarding Magnetic Resonance
Systems
AGENCY: Federal Communications Commission.
ACTION: Final rule.
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SUMMARY: This Report and Order removes unnecessary equipment
authorization requirements for Magnetic Resonance (MR) Systems. This
action is taken in response to a petition from the National Electrical
Manufacturers Association. The intended effect of this action is to
reduce the amount of time and money required to bring new non-consumer,
medical magnetic resonance systems to market.
EFFECTIVE DATE: September 2, 1994.
FOR FURTHER INFORMATION CONTACT:
Errol Chang, Office of Engineering and Technology (202) 653-7316.
SUPPLEMENTARY INFORMATION: This is a summary of the Commission's Report
and Order in ET Docket No. 92-255, FCC 94-155, adopted on June 13, 1994
and released on July 13, 1994. The full text of this Decision is
available for inspection and copying during normal business hours in
the FCC Dockets Branch (Room 230, 1919 M Street, NW., Washington, DC.
The complete text of this decision may also be purchased from the
Commission's duplicating contractor, International Transcription
Services at (202) 857-3800 or 2100 M Street, NW., Suite 140,
Washington, DC 20037.
Paperwork Reduction
Public reporting burden for this collection of information is
estimated to average 18 hours per response including the time for
reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
collection of information. Send comments regarding this burden estimate
or any other aspect of this collection of information, including
suggestions for reducing the burden, to the Federal Communications
Commission, Office of Managing Director, Paperwork Reduction Project
[3060-0329], Washington, DC 20554 and to the Office of Management and
Budget, Paperwork Reduction Project [3060-0329], Washington, DC 20503.
Summary of Report and Order
1. By this action, the Commission is amending Part 18 of its rules
to remove regulations that unnecessarily increase the amount of time
and money required to bring new non-consumer, medical magnetic
resonance (MR) systems to market. These systems are used by medical
professionals to study the molecular structure of a patient for
diagnostic and monitoring purposes. This action is taken in response to
a petition for rule making filed by the National Electrical
Manufacturers Association on January 29, 1992.
2. 47 CFR Part 18 sets forth requirements designed to minimize the
potential for interference to radio and TV services by industrial,
scientific and medical (ISM) equipment. Such equipment generates radio
frequency (RF) energy in order to perform a non-communications related
function. Common examples of non-consumer ISM equipment include
microwave ovens and RF lighting devices. Examples of non-consumer ISM
equipment include industrial heaters, RF stabilized are welders and
magnetic resonance (MR) equipment. Before ISM equipment can be marketed
in the United States, it must comply with the technical standards and
equipment authorization procedures specified in 47 CFR Part 18.
3. It appears that MR systems pose little risk of interference
because of the way they are designed and installed by professionals. We
note that there are under 1000 installations of MR systems. We further
note that, in the event that measures need to be taken to correct
interference, the locations of these installations are on file with
Manufacturers due to U.S. Food and Drug Administration regulations. We
also recognize that the authorization requirement is burdensome and
costly for MR systems. Given the low volume production of MR systems,
such requirements can significantly affect the unit cost of each
system, contributing to the increasing costs of medical care.
4. The circumstances presented here are similar to those that led
us earlier to exempt non-consumer medical ultrasonic equipment from 47
CFR Part 18 rules. We are unaware of any interference that resulted
from the medical ultrasonic equipment exemption. On balance, we
tentatively conclude that the costs of our technical standards and
authorization requirements for MR systems are unwarranted given the low
risk of interference. Accordingly, we are amending 47 CFR Part 18 to
exempt MR systems from the technical standards and authorization
requirements that now apply to them. We will continue to apply the
requirements of 47 CFR Section 18.111(b), which require operators of MR
systems to correct any harmful interference that may occur. The
proposed rule changes are set forth below.
5. Accordingly, it is ordered that pursuant to the authority
contained in Section 4(i) and 303(r) of the Communications Act of 1934,
as amended, 47 CFR Part 18 is amended as set forth below. These Rules
and Regulations are effective 30 days after publication in the Federal
Register. It is further ordered that this proceeding is terminated.
6. For further information on this proceeding, contact Errol Chang,
Technical Standards Branch, Office of Engineering and Technology,
telephone 202-653-7316.
List of Subjects in 47 CFR Part 18
Medical devices, Hospitals, Radio, Reporting and recordkeeping
requirements.
Part 18 of Title 47 of the Code of Federal Regulations is amended
as follows:
PART 18--INDUSTRIAL, SCIENTIFIC, AND MEDICAL EQUIPMENT
1. The authority citation for Part 18 continues to read as follows:
Authority: 47 U.S.C. 4, 301, 302, 303, 304, and 307.
2. Section 18.107 is revised by adding a new paragraph (j) to read
as follows:
Sec. 18.107 Definitions.
* * * * *
(j) Magnetic resonance equipment. A category of ISM equipment in
which RF energy is used to create images and data representing
spatially resolved density of transient atomic resources within an
object.
3. Section 18.121 is revised to read as follows:
Sec. 18.121 Exemptions.
Non-consumer ultrasonic equipment, and non-consumer magnetic
resonance equipment, that is used for medical diagnostic and monitoring
applications is subject to the provision of Sections 18.105, 18.109
through 18.119, 18.301 and 18.303.
Federal Communications Commission.
William F. Caton,
Acting Secretary.
[FR Doc. 94-18799 Filed 8-2-94; 8:45 am]
BILLING CODE 6712-01-M
