[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
