Federal Register / Vol. 63, No. 82 /Wednesday, April 29, 1998 /Rules and Regulations 23385

Service bulletin referenced and date Page No.

Revision

level

shown on

page

Date shown on page

Rolls Royce Service Bulletin RB.211–72–

4666, Revision 3, October 14, 1977.

1 ..................................................................... 3 .............. October 14, 1977.

2–6, 6A, 7–10 ................................................ 2 .............. August 26, 1977.

This incorporation by reference was

approved by the Director of the Federal

Register in accordance with 5 U.S.C. 552(a)

and 1 CFR part 51. Copies may be obtained

from Lockheed Aeronautical Systems

Support Company (LASSC), Field Support

Department, Dept. 693, Zone 0755, 2251 Lake

Park Drive, Smyrna, Georgia 30080. Copies

may be inspected at the FAA, Transport

Airplane Directorate, 1601 Lind Avenue,

SW., Renton, Washington; or at the FAA,

Small Airplane Directorate, Atlanta Aircraft

Certification Office, One Crown Center, 1895

Phoenix Boulevard, Suite 450, Atlanta,

Georgia 30349; or at the Office of the Federal

Register, 800 North Capitol Street, NW., suite

700, Washington, DC.

(h) This amendment becomes effective on

June 3, 1998.

Issued in Renton, Washington, on April 21,

1998.

Gary L. Killion,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 98–11088 Filed 4–28–98; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 892

[Docket No. 96N–0320]

Radiology Devices; Classifications for

Five Medical Image Management

Devices

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is classifying five

radiology devices that provide functions

related to medical image

communication, storage, processing,

and display into class I (general

controls) or class II (special controls).

The medical image storage device and

medical image communications device

are classified into class I, and they are

exempted from the requirement of

premarket notification when they do not

use irreversible compression. The

medical image digitizer, the medical

image hardcopy device, and the picture

archiving and communications system

are classified into class II. These actions

are being taken under the Federal Food,

Drug, and Cosmetic Act (the act), as

amended by the Medical Device

Amendments of 1976 and the Safe

Medical Devices Act of 1990.

EFFECTIVE DATE: May 29, 1998.

FOR FURTHER INFORMATION CONTACT:

Loren A. Zaremba, Center for Devices

and Radiological Health (HFZ–470),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–1212.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of December 2,

1996 (61 FR 63769), FDA issued a

proposed rule to classify five medical

image management devices into class I

or class II. The medical image storage

device and medical image

communications device were proposed

to be classified into class I, and

exempted from the requirement of

premarket notification when they do not

use irreversible compression. The

medical image digitizer, medical image

hardcopy device, and picture archiving

and communications system were

proposed to be classified into class II.

FDA provided for interested persons to

submit written comments on the

proposal by March 3, 1997.

II. Response to Comments

The agency received six comments

responding to the proposed rule. These

comments were submitted by a law

firm, two manufacturers of medical

image management devices, two

medical professional organizations, and

a medical device manufacturers’

association.

1. One comment expressed concern

that exempting medical image storage

devices from the requirement of

premarket notification would encourage

less experienced manufacturers to use

the marketplace as a testing ground for

their new products. This comment

stated that the medical image

management industry needs guidance

from FDA on material choices, labeling,

and quality assurance issues. The

comment also suggested that FDA

consider adopting minimum standards

relating to specifications, device

compatibility, lifetime, and labeling.

FDA agrees that the integrity of

medical image storage devices is

important in health care. The agency

does not believe, however, that

premarket notification is necessary to

ensure the safety and effectiveness of

these products. The agency believes that

other general controls, particularly the

good manufacturing practices

requirements (part 820) (21 CFR part

820)), which include controls on

production, packaging, labeling, and

recordkeeping, are sufficient to provide

reasonable assurance of their safety and

effectiveness. On November 21, 1997,

the President signed into law the Food

and Drug Administration Modernization

Act of 1997 (FDAMA) (Pub. L. 105–115).

Section 206(a)(2) of FDAMA added

sections 510(l) and 510(m) to the act (21

U.S.C. 360(l) and (m)). Section 510(l) of

the act provides that a premarket

notification is not required for a class I

device, unless the device is intended for

a use that is of substantial importance

in preventing impairment of human

health or the device presents a potential

unreasonable risk of illness or injury.

Section 510(m) of the act provides that

FDA may exempt a class II device from

the premarket notification requirements

if FDA determines that a premarket

notification is not necessary to provide

reasonable assurance of the safety and

effectiveness of the device. FDA has

determined that the medical image

storage device and the medical image

communications device do not require

premarket notifications in accordance

with the criteria in section 510(l) of the

act. Also, FDA has determined that the

medical image digitizer, the medical

image hardcopy device, and the picture

archiving and communication system

require premarket notification in order

to provide reasonable assurance of their

safety and effectiveness. The class II

devices in this rule will be subject to the

design control requirements in part 820,

while the class I devices will be exempt

from the design control requirements in

accordance with § 820.30. FDA believes

that design controls are not necessary

for class I devices in this rule. To

provide guidance to the industry, FDA

will continue to participate in the

activities of voluntary standards

organizations in the development of

recommendations relating to materials
23386 Federal Register / Vol. 63, No. 82 /Wednesday, April 29, 1998 /Rules and Regulations

specifications, compatibility, labeling,

and quality assurance issues associated

with these devices.

2. One comment stated that an

additional classification is needed for

digital image capture devices, such as

computed radiography, which do not

have an integral x-ray source.

FDA agrees that a classification for

digital image receptors, which would be

applicable to computed radiography, as

well as other technologies such as thinfilm transistor arrays, is needed.

However, because a classification of this

type of device was not included in the

initial proposal, the agency believes it

would be inappropriate to include such

devices in this final rule. The agency

intends to propose classification of

these types of devices, and provide an

opportunity for public comment, in a

future rulemaking action.

3. One comment requested

confirmation in the preamble of the

final rule of their understanding that a

‘‘physician practice management

system’’ is not a medical image

management device, and is not subject

to active regulation as a medical device

if it does not possess any medical image

management or processing functions.

FDA confirms that the classifications

for medical image management devices

include only devices which provide

functions related to medical image

communication, storage, processing,

and display. Image capture programs,

commonly called physician practice

management systems or radiology

information systems, which are

restricted to the management of patient

descriptive information, examination

scheduling, billing, and other similar

data, are not within the scope of these

classifications.

4. One comment noted that it appears

that the agency intends to place more

stringent requirements on medical

image management devices which

utilize irreversible compression. The

comment agreed that caution is

advisable in evaluating such devices,

and that images subjected to irreversible

compression should be properly

labeled. It was pointed out, however,

that some degree of loss in data

resulting from irreversible compression

is acceptable in certain clinical

applications.

The agency has concluded that

devices that do not utilize irreversible

compression should be exempt from the

requirement of premarket notification.

Because such products do not alter

image content, FDA believes that

premarket evaluation is not necessary

for such devices, if good manufacturing

practices are employed to ensure storage

and communications fidelity. FDA

believes that devices that do utilize

irreversible compression should be

evaluated prior to marketing because

such devices induce a loss of

information that can affect the

suitability of the image for use in

diagnosis. This evaluation will include

an examination of the compression

algorithm, the amount of information

loss over the range of compression

levels utilized as compared to

established algorithm, and the labeling

employed to inform users that

irreversible compression has been

applied.

5. The agency is also taking this

opportunity to address the issue of the

applicability of these classifications to

devices that are intended for use in the

management of visible light images.

The medical image storage device, the

medical image communications device,

the medical image digitizer, the medical

image hardcopy device, and the picture

archiving and communications system,

which are classified by this final rule,

are listed in 21 CFR part 892, which is

a listing of radiology devices. The

identifications of these devices,

however, refer to medical images, and

are not restricted to radiology images.

Consequently, sponsors of devices

intended for use in the management of

visible light images or images obtained

from other nonradiological imaging

modalities may in general use these

radiology classifications, for purposes of

seeking to establish substantial

equivalence, if there does not exist a

classification for a similar product that

is more specifically applicable to the

images. However, decisions regarding

the substantial equivalence of

nonradiological devices to the medical

image management device

classifications being finalized here will

be made on a case-by-case basis.

III. Final Classifications

After reviewing the public comments,

the agency has determined that it is

appropriate to classify the devices as

proposed. Accordingly, the medical

image storage device and medical image

communications device when they do

not use irreversible compression are

classified into class I.

The medical image digitizer, the

medical image hardcopy device, and the

picture archiving and communications

system are classified into class II. The

following voluntary standards will serve

as special controls to ensure the safe

and effective use of these devices:

1. The Digital Imaging and

Communications in Medicine standard,

developed by the American College of

Radiology and the National Electrical

Manufacturers Association (NEMA),

which specifies the format for the

communication of digital images

between individual devices as well as

over networks. This standard has solved

many of the problems of incompatibility

between medical image management

devices caused by the use of proprietary

image file formats. A copy of the

standard may be obtained from NEMA,

1300 North 17th St., Rosslyn, VA 22209.

2. The Joing Photographic Experts

Group (JPEG) standard, which specifies

methods for the compression (reversible

and irreversible) of digital medical

images (see Ref. 1).

3. The Society of Motion Picture and

Television Engineers test pattern, which

is used to test CRT monitors and

printers used to display medical images

for acceptance and quality control

purposes (see Ref. 2).

IV. References

1. Wallace, G. K., ‘‘The JPEG Still Picture

Compression Standard,’’ Communications of

the ACM, vol. 34, No. 4, April 1991.

2. Gray, J. E. et al., ‘‘Multiformat Video

and Laser Cameras: History, Design

Considerations, Acceptance Testing and

Quality Control,’’ Report of AAPM Diagnostic

X-ray Imaging Committee Task Group No. 1,

Medical Physics, vol. 20, No. 2, part 1,

March/April 1993.

V. Environmental Impact

The agency has determined under 21

CFR 25.34(b) that this action is of a type

that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

VI. Analysis of Impacts

FDA has examined the impacts of the

final rule under Executive Order 12866

and the Regulatory Flexibility Act (Pub.

L. 96–354) (as amended by subtitle D of

the Small Business Regulatory

Enforcement Fairness Act of 1996 (Pub.

L. 104–121), and the Unfunded

Mandates Reform Act of 1995 (Pub. L.

104–4). Executive Order 12866 directs

agencies to assess all costs and benefits

of available regulatory alternatives and,

when regulation is necessary, to select

regulatory approaches that maximize

net benefits (including potential

economic, environmental, public health

and safety and other advantages;

distributive impacts; and equity). The

agency believes that this final rule is

consistent with the regulatory

philosophy and principles identified in

the Executive Order. In addition, the

final rule is not a significant regulatory

action as defined by the Executive Order

and so is not subject to review under the

Executive Order.
Federal Register / Vol. 63, No. 82 /Wednesday, April 29, 1998 /Rules and Regulations 23387

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

entities. Because this final rule does not

impose any new requirements, the

Commissioner of Food and Drugs

certifies that this final rule will not have

a significant economic impact on a

substantial number of small entities. In

addition, this final rule will not impose

costs of $100 million or more on either

the private sector or State, local, and

tribal governments in the aggregate and,

therefore a summary statement or

analysis under section 202(a) of the

Unfunded Mandates Reform Act of 1995

is not required.

List of Subjects in 21 CFR Part 892

Medical devices, Radiation

protection, X-rays.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 892 is

amended as follows:

PART 892—RADIOLOGY DEVICES

1. The authority citation for 21 CFR

part 892 continues to read as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e,

360j, 371.

2. Sections 892.2010, 892.2020,

892.2030, 892.2040, and 892.2050 are

added to subpart B to read as follows:

§ 892.2010 Medical image storage device.

(a) Identification. A medical image

storage device is a device that provides

electronic storage and retrieval

functions for medical images without

irreversible data compression. Examples

include devices employing magnetic

and optical discs, magnetic tape, and

digital memory.

(b) Classification. Class I. The device

is exempt from the premarket

notification procedures in subpart E of

part 807 of this chapter.

§ 892.2020 Medical image communications

device.

(a) Identification. A medical image

communications device provides

electronic transfer of medical image data

between medical devices without

irreversible data compression. It may

include a physical communications

medium, modems, interfaces, and a

communications protocol.

(b) Classification. Class I. The device

is exempt from the premarket

notification procedures in subpart E of

part 807 of this chapter.

§ 892.2030 Medical image digitizer.

(a) Identification. A medical image

digitizer is a device intended to convert

an analog medical image into a digital

format. Examples include Iystems

employing video frame grabbers, and

scanners which use lasers or chargecoupled devices.

(b) Classification. Class II (special

controls; voluntary standards—Digital

Imaging and Communications in

Medicine (DICOM) Std., Joint

Photographic Experts Group (JPEG)

Std.).

§ 892.2040 Medical image hardcopy

device.

(a) Identification. A medical image

hardcopy device is a device that

produces a visible printed record of a

medical image and associated

identification information. Examples

include multiformat cameras and laser

printers.

(b) Classification. Class II (special

controls; voluntary standards—Digital

Imaging and Communications in

Medicine (DICOM) Std., Joint

Photographic Experts Group (JPEG) Std.,

Society of Motion Picture and

Television Engineers (SMPTE) Test

Pattern).

§ 892.2050 Picture archiving and

communications system.

Identification. A picture archiving

and communications system is a device

that provides one or more capabilities

relating to the acceptance, transfer,

display, storage, and digital processing

of medical images. Its hardware

components may include workstations,

digitizers, communications devices,

computers, video monitors, magnetic,

optical disk, or other digital data storage

devices, and hardcopy devices. The

software components may provide

functions for performing operations

related to image manipulation,

enhancement, compression or

quantification.

(b) Classification. Class II (special

controls; voluntary standards—Digital

Imaging and Communications in

Medicine (DICOM) Std., Joint

Photographic Experts Group (JPEG) Std.,

Society of Motion Picture and

Television Engineers (SMPTE) Test

Pattern).

Dated: April 13, 1998.

D.B. Burlington,

Director, Center for Devices and Radiological

Health.

[FR Doc. 98–11317 Filed 4–28–98; 8:45 am]

BILLING CODE 4160–01–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 52

[GA–035–9807a; FRL–6004–8]

Approval and Promulgation of

Implementation Plans; Georgia:

Approval of Revisions for

Transportation Control Measures

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Direct final rule.

SUMMARY: EPA is approving revisions to

the Georgia State Implementation Plan

(SIP) submitted by the Department of

Natural Resources on August 29, 1997,

requesting the incorporation of several

transportation control measures (TCMs)

and the deletion of two TCMs from the

existing SIP. This action will only

address the incorporation of four of the

five TCMs requested for incorporation.

The other TCM actions will be handled

under separate ruelmaking action. The

four TCMs, subject to this action

include: The addition of a high

occupancy vehicle (HOV) lane, an

employer-based program, a university

ridershare program, development of

transportation management

associations. This action does not

address the alternative fuel station

vanpool project, the five express bus

routes on Cobb Community

Transportation (CCT) and two park and

ride lots on CCT routes.

DATES: This final rule is effective June

15, 1998 unless adverse or critical

comments are received by May 29, 1998.

If adverse comments are received EPA

will publish a timely withdrawal of this

rule.

ADDRESSES: Written comments on this

action should be addressed to Kelly A.

Sheckler at the Environmental

Protection Agency, Region 4 Air

Planning Branch, 61 Forsyth Street, SW,

Atlanta, Georgia 30303. Copies of

documents relative to this action are

available for public inspection during

normal business hours at the following

locations. The interested persons

wanting to examine these documents

should make an appointment with the

appropriate office at least 24 hours

before the visiting day. Reference file

GA35–9807. The Region 4 office may

have additional background documents

not available at the other locations.

Air and Radiation Docket and

Information Center (Air Docket 6102),

U.S. Environmental Protection

Agency, 401 M Street, SW,

Washington, DC 20460

Environmental Protection Agency,

Region 4 Air Planning Branch, 61