[Federal Register Volume 63, Number 82 (Wednesday, April 29, 1998)]
[Rules and Regulations]
[Pages 23385-23387]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-11317]


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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.

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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 
Sec. 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

[[Page 23386]]

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 thin-film 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.

[[Page 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:


Sec. 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.


Sec. 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.


Sec. 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 charge-coupled devices.
    (b) Classification. Class II (special controls; voluntary 
standards--Digital Imaging and Communications in Medicine (DICOM) Std., 
Joint Photographic Experts Group (JPEG) Std.).


Sec. 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).


Sec. 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