[Federal Register Volume 61, Number 232 (Monday, December 2, 1996)]
[Proposed Rules]
[Pages 63769-63774]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-30650]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 892

[Docket No. 96N-0320]


Radiology Devices; Proposed Classifications for Five Medical 
Image Management Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration is proposing to classify five 
generic types of radiology devices that provide functions related to 
medical image communication, storage, processing, and display. Under 
the proposal, the medical image storage device and the medical image 
communications device would be classified into class I (general 
controls),

[[Page 63770]]

and would be 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 would be classified into class II (special 
controls). The agency is publishing in this document the 
recommendations of the Radiology Devices Panel regarding the 
classification of these devices. After considering public comments on 
the proposed classifications, FDA will publish a final regulation 
classifying these devices. This action is being taken to establish 
sufficient regulatory controls that will provide reasonable assurance 
of the safety and effectiveness of these devices.

DATES: Written comments must be submitted on or before March 3, 1997. 
FDA proposes that any final regulation that may issue based on this 
proposal become effective 30 days after the date of its publication in 
the Federal Register.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

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

A. Classification of Medical Devices

    The Federal Food, Drug, and Cosmetic Act (the act), as amended by 
the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L. 
94-295) and the Safe Medical Devices Act of 1990 (Pub. L. 101-629), 
established a comprehensive system for the regulation of medical 
devices intended for human use. Section 513 of the act (21 U.S.C. 360c) 
established three classes of devices, depending on the regulatory 
controls needed to provide reasonable assurance of their safety and 
effectiveness. The three classes of devices are class I (general 
controls), class II (special controls), and class III (premarket 
approval). Procedures for the original classification of devices that 
were in commercial distribution before May 28, 1976 (the date of 
enactment of the 1976 amendments), are set forth in section 513 of the 
act and in 21 CFR 860.84. In accordance with these procedures, devices 
are classified after FDA has: (1) Received a recommendation from a 
device classification panel (an FDA advisory committee); (2) published 
the panel's recommendations for comment, along with a proposed 
regulation classifying the device; and (3) published a final regulation 
classifying the device.
    A device that is first offered in commercial distribution after May 
28, 1976, and that FDA determines to be substantially equivalent to a 
device classified under this scheme is classified into the same class 
as the device to which it is substantially equivalent. The agency 
determines whether new devices are substantially equivalent to 
previously offered devices by means of premarket notification 
procedures in section 510(k) of the act (21 U.S.C. 360(k)) and 21 CFR 
part 807. A device that was not in commercial distribution prior to May 
28, 1976, and that has not been found by FDA to be substantially 
equivalent to a legally marketed device is classified automatically by 
statute (section 513(f) of the act) into class III without any FDA 
rulemaking proceedings.
    Section 513(d)(2)(A) of the act authorizes FDA to exempt, by 
regulation, a generic type of class I device from, among other things, 
the requirement of premarket notification in section 510(k) of the act. 
Such an exemption permits manufacturers to introduce into commercial 
distribution generic types of devices without first submitting a 
premarket notification to FDA. If FDA has concerns only about certain 
types of changes to a particular class I device, the agency may grant a 
limited exemption from premarket notification for that generic type of 
device. A limited exemption will specify the types of changes to the 
device for which manufacturers are required to submit a premarket 
notification. For example, FDA may exempt a device from the requirement 
of premarket notification except when a manufacturer intends to use a 
different material.
    To date, FDA has classified a total of 70 generic types of 
radiology devices (see 53 FR 1554, January 20, 1988; 54 FR 5077, 
February 1, 1989; and 55 FR 48436, November 20, 1990). With the 
exception of the magnetic resonance diagnostic device (21 CFR 
892.1000), all of these 70 generic devices are of a type that were on 
the market before the enactment of the 1976 amendments. Of the 70 
generic types of radiology devices, FDA exempted 8 from the requirement 
of premarket notification (54 FR 13826, April 5, 1989, and 59 FR 63005, 
December 7, 1994); of the 8 exempt devices, FDA exempted 7 with no 
limitations. The nuclear scanning bed (21 CFR 892.1350), however, is 
exempt only when the device is labeled with the weight limit, is used 
with planar scanning only, and is not intended for diagnostic x-ray 
use.

B. Medical Image Management Devices

    Developments in electronic data communications and storage 
technologies in recent years have led to the introduction of a number 
of radiological devices that are intended for use in the management of 
medical images after acquisition (Refs. 1 and 2). For digital 
modalities such as computed tomography (CT), magnetic resonance imaging 
(MRI), ultrasound, digital subtraction angiography, and computed 
radiography, the images are acquired in digital form and therefore lend 
themselves immediately to digital image management techniques. For 
analog devices such as conventional x-ray, devices have been developed 
to convert film images into a digital format.
    A number of acronyms are used to describe medical image management 
devices, such as picture archiving and communications systems (PACS) 
and image management and communications systems (IMACS). The acronyms 
arise from the fact that the devices are principally utilized for the 
communication and storage of images. However, the digital format also 
facilitates the application of image processing and enhancement 
techniques, and these techniques are now available as features on many 
of these products.
    The digital format utilized in medical image management devices 
provides a number of advantages, including the ability to transmit and 
receive images rapidly with high fidelity when used with digital 
communications technology. The devices, when utilized with electronic 
media such as random access memory (RAM), hard disks, and optical 
disks, also allow compact storage with rapid retrieval capability (Ref. 
3).
    However, image viewing is inherently an analog process. Presently, 
image display is performed using video monitors or hardcopy, and both 
are subject to limitations (Refs. 4, 5, and 6). Current video monitors 
do not provide brightness comparable to film/lightbox viewing, which 
limits the number of discernable grey levels. Also, the highest 
resolution video monitors presently available are 2048 x 2048 pixels, 
and the majority in clinical use are 1024 x 1024 pixels or less. 
Consequently, the number of addressable pixels on the video monitor can 
limit the available spatial resolution if that number is less than the 
matrix

[[Page 63771]]

size of the original image (which is always the case for an original x-
ray film image). Laser and video printers are available for converting 
digital images to hardcopy, but this conversion process involves a 
sacrifice of the communication and storage advantages of the digital 
technology.
    Many of the medical image management products included in this 
proposal did not exist when the radiological device classifications 
were first proposed in 1982. However, FDA has generally treated them as 
accessories to the imaging modalities (e.g., x-ray systems, CT 
scanners, and MRI systems) with which they are used, consistent with 
the identifications of these modalities. For example, the medical image 
digitizer and medical image hardcopy device (multiformat camera) have 
been considered to be accessories to the stationary x-ray system (21 
CFR 892.1680) and computed tomography x-ray system (21 CFR 892.1750), 
respectively.
    A significant expansion in the technical characteristics and 
functions of medical image management products has taken place in 
recent years so that the identification of many of these products as 
accessories to a specific radiological imaging modality is no longer 
entirely accurate. For example, medical image hardcopy devices, medical 
image storage devices, medical image communications devices, and 
picture archiving and communications systems are frequently intended 
for use with most or all imaging modalities. The classification action 
described in this proposal would establish independent classifications 
for medical image management products, consistent with their 
multimodality use.
    FDA originally developed a guidance document for the submission of 
premarket notifications for PACS devices in 1991, which the agency 
updated in August 1993 (Ref. 7). This document outlines the suggested 
information for a premarket notification for PACS devices and related 
components. However, because no specific classifications have been 
established for these devices, uncertainty exists among manufacturers 
regarding whether medical image management products are medical devices 
and whether premarket notifications are required. The establishment of 
separate classifications for medical image management devices will help 
clarify the regulatory status of these devices. At the same time, the 
agency is proposing to exempt two of these devices from the requirement 
of premarket notification, with limitations. These exemptions will 
enable the agency to concentrate its resources on the evaluation of 
more critical products, and they will make it easier for manufacturers 
of the exempt devices to bring them to market.
    It should be noted that the classifications will usually not apply 
to general purpose products, such as general purpose software, digital 
communications devices, and storage devices, that are not intended for 
medical use. These products are not considered to be medical devices. 
However, when they are intended for use in the diagnosis of disease or 
other conditions, or in the cure, mitigation, or prevention of disease, 
or are intended to affect the structure or any function of the body, 
they are devices within the meaning of section 201(h) of the act (21 
U.S.C. 321(h)). Intended use may be revealed by how the product is 
labeled, or if it is included as a component of a system labeled for 
medical use.

II. Panel Recommendations

    The Radiological Devices Panel (the Panel), an FDA advisory 
committee, met on August 29, 1994, to review the proposed 
classifications. The Panel concluded that the proposed identifications 
are adequate, clear, and sufficiently inclusive.
    The Panel recommended that medical image storage devices and 
medical image communications devices be placed in Class I and that 
devices that do not use irreversible compression be exempted from the 
requirement of premarket notification. As its reason for this 
recommendation, the Panel stated its belief that general controls are 
sufficient to provide reasonable assurance of the safety and 
effectiveness of these devices. The Panel recommended that devices that 
do not use irreversible compression be exempted from the requirement of 
premarket notification because these products are transparent to the 
user and FDA review of premarket notifications are unnecessary for the 
protection of the public health.
    The Panel recommended that medical image digitizers, medical image 
hardcopy devices, and picture archiving and communications systems be 
placed in Class II. The Panel stated as reasons for this recommendation 
the need for special controls, such as voluntary performance standards 
and testing guidelines, to ensure their safe and effective use. The 
Panel based its recommendations on its review of the studies cited in 
this document, premeeting briefing materials, and on the Panel members' 
personal knowledge of, and experience with, these devices. The Panel 
listed inadequate or inaccurate data leading to improper diagnosis as 
risks to health associated with the use of these devices. The Panel 
listed Digital Imaging and Communications in Medicine (DICOM), Joint 
Photographic Experts Group (JPEG), and Society of Motion Picture and 
Television Engineers (SMPTE) as relevant standards.
    At the August 29, 1994, Panel meeting, representatives of the 
National Electrical Manufacturers Association (NEMA) stated opposition 
to the establishment of a separate classification for picture archiving 
and communications systems, recommending instead that FDA limit the 
classifications to components of such systems. However, the Panel 
dismissed this objection, noting that a manufacturer would have the 
option of obtaining marketing clearance for the entire system or for 
individual components. FDA believes that the establishment of a 
classification for PACS is needed because it is not feasible to 
establish separate classifications for all possible PACS components. 
The classification for PACS is intended to include those devices 
associated with medical image transmission, storage, processing, and 
display for which separate classifications have not been established. 
Also, the PACS classification will apply to the majority of premarket 
notifications for medical image management devices which are submitted 
for systems rather than for individual components. NEMA and other 
interested parties may submit alternative classification schemes in 
response to this proposal.
    Summary minutes and a verbatim transcript of the Panel meeting have 
been placed in the Dockets Management Branch (address above).

III. Proposed Classifications

    Based upon the types of equipment described in past and current 
premarket notifications, FDA has identified five generic types of 
radiology devices that provide functions relating to medical image 
management: The medical image communications device, the medical image 
storage device, the medical image digitizer, the medical image hardcopy 
device, and the picture archiving and communications system.

A. Medical Image Communications Devices and Medical Image Storage 
Devices

    The two most basic types of medical image management devices are 
communications and storage products. A medical image communications 
device provides electronic transfer of

[[Page 63772]]

medical image data between medical devices. It includes the physical 
communications media (e.g., a twisted pair or fiber optic cable), 
modems, interfaces, and communications protocols that are marketed as 
part of the device. However, it does not include elements of the 
communications infrastructure, such as commercial telephone lines.
    A medical image storage device is a device that provides electronic 
storage and retrieval functions for medical images. A medical image 
storage device may be comprised of microprocessors, interfaces, 
software, and one or more storage media. Examples of storage media 
include magnetic and optical discs, magnetic tape, and digital memory 
(e.g., RAM).
    The safety and efficacy issues associated with these devices may be 
categorized as data integrity and device compatibility. An extremely 
high level of integrity has been achieved in electronic data 
transmission and storage through the use of modern error-checking 
methods, so that FDA does not consider data integrity to be a 
significant problem.
    For a number of years device compatibility was a serious concern 
for image communications and storage devices because many manufacturers 
utilized proprietary image file formats. However, the American College 
of Radiology (ACR) and NEMA have developed a protocol for sharing 
digital images between medical devices called DICOM. This standard 
(Ref. 8) has been incorporated by a number of manufacturers into their 
new products and several companies are offering interfaces to convert 
the proprietary image formats utilized in older equipment to the DICOM 
format. Consequently, the compatibility issue is of decreasing concern.
    However, in recent years there has been a marked increase in the 
number of devices that utilize data compression techniques to reduce 
image transmission time and data storage requirements (Ref. 9). The 
utilization of data compression has been accelerated by the development 
of the JPEG standard and the commercial availability of microprocessors 
for performing JPEG compression (Ref. 10). Data compression methods are 
of two types, reversible or irreversible. Reversible data compression 
methods are such that the original image data may be retrieved 
following the compression process. With irreversible data compression 
methods, portions of the original data are irretrievably lost. 
Irreversible data compression is generally done so as to sacrifice 
information that is least likely to be useful to the reader, e.g., 
higher spatial frequencies (fine detail).
    The current version of the guidance document for the submission of 
premarket notifications for PACS devices suggests specific labeling for 
devices that use irreversible data compression. The guidance document 
suggests that video image displays and hardcopy images that have been 
subjected to irreversible compression should display a message stating 
that irreversible compression has been applied and should state the 
approximate compression ratio. This message is consistent with the ACR 
Standard for Teleradiology (Ref. 11), which requires that transmitting 
stations must have annotation capabilities that include the degree of 
compression.
    FDA currently receives and evaluates a large number of premarket 
notifications for medical image communications and storage devices each 
year. Many of these devices are transparent to the user, i.e., the 
input and output data are identical. Consequently, FDA is proposing 
that they be placed in Class I and be exempted from the requirement of 
premarket notification. Granting these exemptions will allow the agency 
to make better use of its resources and thus better serve the public.
    FDA is not proposing to exempt devices that perform irreversible 
compression from the requirement of premarket notification. At present 
there is a great deal of activity in the development and clinical 
evaluation of algorithms for the irreversible compression of medical 
image data. Review of premarket notifications for devices that use 
irreversible compression will provide FDA with the opportunity to 
evaluate these algorithms on an individual basis to ensure that their 
suitability for use in the medical application has been demonstrated.

B. Medical Image Digitizers and Hardcopy Devices

    The medical image digitizer is a device that converts an analog 
medical image into a digital format. Most radiological examinations are 
still conducted with x-ray film as the image receptor and digitizers 
provide a means for converting the film information to digital form. 
Medical image hardcopy devices provide the opposite function, i.e., 
they convert an image from an electronic form to a visual printed 
record.
    The principal types of digitizers currently in use are frame 
grabbers, charge coupled devices (CCD's), and laser scanners. Frame 
grabbers may be coupled to the video output of the imaging device, or 
to the output of a video camera placed over the film. CCD's may be 
linear scanners or arrays. The various types of digitizers differ in 
spatial resolution, range of film density that can be digitized, and 
grey level discrimination capability. A discussion of performance 
differences and appropriate testing and quality control procedures for 
various types of digitizers is in Ref. 12.
    The most common examples of hardcopy devices are multiformat 
cameras and laser printers. Multiformat cameras produce copies by 
exposing film to an image on a video monitor. Laser printers produce 
copies by modulating a laser beam that is scanned over the film. 
Recently, FDA has granted marketing clearance to devices that produce 
reflective paper hardcopy by means of inkjet, laser/dry silver, and 
thermal processes. As with digitizers, the quality of the hardcopy that 
can be obtained depends on the design of the device. However, most of 
the standard measures of image quality are applicable to hardcopy 
devices, and recommendations have been made regarding appropriate 
testing and quality control procedures. A description of such 
procedures using the SMPTE test pattern is in Ref. 5. The use of this 
pattern is also recommended in the ACR Standard for Teleradiology.
    The performance characteristics of both digitizers and hardcopy 
devices can have a significant influence on diagnostic capability and 
patient care. Also, adequate quality control procedures are needed to 
ensure their continued performance. FDA is working with voluntary 
standards groups to develop standardized specifications, test methods, 
and quality control procedures for digitizers and hardcopy devices. The 
attention that has been given to the problems associated with 
performance and quality control in the literature and by standards 
groups indicates that special controls (e.g., voluntary standards) are 
needed to ensure the safety and efficacy of these devices. 
Consequently, FDA is proposing that they be placed in Class II.

C. Picture Archiving and Communications System

    A picture archiving and communications system is defined in this 
proposal as a device that provides one or more capabilities relating to 
the acceptance, transfer, display, storage, and processing of medical 
images. This classification is intended to include products that 
combine several functions and that are marketed as PACS systems. It 
would include systems ranging in

[[Page 63773]]

complexity from teleradiology products (small, portable devices that 
transmit images over phone lines and enable an on-call radiologist to 
review images in his/her home) to large fixed systems that utilize 
fiber optic networks and are capable of transmitting and storing images 
for an entire hospital or group of hospitals.
    Another common example of this device is the medical image 
workstation, which is generally comprised of a computer, video monitor, 
and storage device. The computer generally utilizes software related to 
data communications, file management, and image processing. The 
classification is also intended to include devices which provide image-
related capabilities, and for which there are no other specific 
classifications, such as image processing software and video monitors.
    Software is an important component of a PACS device. It is 
generally responsible for data file organization and also may provide 
image processing functions such as filtering (e.g., edge enhancement), 
measurement (e.g., distance, area, and volume determinations), and 
special image displays (three dimensional surface and volume 
rendering). Stand-alone software marketed for use in PACS devices would 
be included in this classification unless it is general purpose 
software that is not intended for a medical use.
    Video monitors are also an important component of PACS devices. 
Manufacturers have generally not submitted separate premarket 
notifications for monitors, but rather have included them in 
submissions for devices such as workstations. Some video monitors are 
general purpose consumer products. However, most monitors used in 
medical imaging are specialized devices with high brightness and 
spatial resolution (1,000 lines or greater). These monitors can take 
the place of film and their characteristics can have a significant 
effect on the ability of health professionals to make a diagnosis.
    A discussion of the important performance characteristics of video 
monitors (e.g., luminance, dynamic range, distortion, resolution, and 
noise) and the need for standards is in Ref. 4. The National 
Information Display Laboratory is currently working with Committee JT-
20 of the Electronic Industries Association (EIA) to develop 
standardized procedures for measuring the performance of cathode ray 
tube (video monitor) displays (Ref. 13). Also, Working Group XI of the 
ACR/NEMA Committee is currently developing a standard display function 
for video monitors (Ref. 14).
    FDA is proposing to classify picture archiving and communication 
systems into Class II. FDA believes that special controls such as 
standardized performance specifications, measurement methods, and 
quality control procedures are necessary to assure the safety and 
efficacy of these devices. Documents addressing these subjects have 
been or are currently being developed by the ACR, NEMA, and EIA.
    If a PACS device includes components that would otherwise be exempt 
from the requirement of premarket notification (e.g., general purpose, 
communication, or storage devices), the premarket notification for the 
system would not be required to include a demonstration of substantial 
equivalence for the exempt components.

IV. References

    The following references have been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. ``PACS, A NEMA Primer,'' published by the National Electrical 
Manufacturer's Association, compiled by the members of the MEDPACS 
Section of the Diagnostic Imaging and Therapy Systems Division, 
November 1988.
    2. Choplin, R. H., J. M. Boehme, and C. D. Maynard, ``Picture 
Archiving and Communications Systems: An Overview,'' Radiographics, 
vol. 12, No. 1, 1992.
    3. Frost, M. M., J. C. Honeyman, and E. V. Staab, ``Image 
Archival Technologies,'' Radiographics, vol. 12, No. 2, 1992.
    4. Dwyer, S. J. et al., ``Performance Characteristics and Image 
Fidelity of Gray-Scale Monitors,'' Radiographics, vol. 12, No. 4, 
1992.
    5. 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.
    6. Kato, H., ``Hard- and Soft-Copy Image Quality,'' in 
``Syllabus: A Categorical Course in Physics--Physical and Technical 
Aspects of Angiography and Interventional Radiology,'' edited by 
Stephen Balter and Thomas B. Shope, presented at the 81st Scientific 
Assembly and Annual Meeting of the Radiological Society of North 
America, November 26-December 1, 1995, RSNA Publications, Oak Brook, 
IL.
    7. ``Guidance for Content and Review of 510(k) Notifications for 
Picture Archiving and Communications Systems (PACS) and Related 
Devices,'' Office of Device Evaluation, Center for Devices and 
Radiological Health, August 1993.
    8. Bidgood, W. D., and S. C. Horii, ``Introduction to the ACR-
NEMA DICOM Standard,'' Radiographics, vol. 12, No. 2, 1992.
    9. Zaremba, L. A., and R. A. Phillips, ``Image Compression--
Regulatory Issues and Policies,'' presented at the 35th Annual 
Meeting of the American Association of Physicists in Medicine, 
Washington, DC, August 8-12, 1993.
    10. Wallace, G. K., ``The JPEG Still Picture Compression 
Standard,'' Communications of the ACM, vol. 34, No. 4, April 1991.
    11. ``ACR Standard for Teleradiology,'' available from the 
American College of Radiology, Reston, VA.
    12. Trueblood, J. H., S. E. Burch, K. Kearfott, and K. W. 
Brooks, ``Radiographic Film Digitization,'' in ``Digital Imaging, 
Medical Physics Monograph 22,'' edited by W. R. Hendee and J. H. 
Trueblood, Medical Physics Publishing, Madison, WI, 1993.
    13. ``Display Monitor Measurement Methods Under Discussion by 
EIA (Electronic Industries Association) Committee JT-20,'' National 
Information Display Laboratory, Princeton, NJ.
    14. Blume, H., S. Daly, and E. Juka, ``Presentation of Medical 
Images on CRT Displays: A Renewed Proposal for a Display Function 
Standard,'' Proceedings of the SPIE, vol. 1987, pp. 215-231, 1993.

V. Environmental Impact

    The agency has determined under 21 CFR 25.24(e)(2) 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 impact of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). 
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 proposed rule is consistent with the regulatory philosophy and 
principles identified in the Executive Order. In addition, the proposed 
rule is not a significant regulatory action as defined by the Executive 
Order and therefore is not subject to review under the Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because the agency believes only a small number of 
firms will be affected by this rule when finalized, and because the 
burdens associated with the

[[Page 63774]]

classification of these devices into Class I and Class II, as proposed, 
is significantly less than those associated with the alternative 
classification into Class III, the agency certifies that the proposed 
rule will not have a significant economic impact on a substantial 
number of small entities. Therefore, under the Regulatory Flexibility 
Act, no further analysis is required.

VII. Request for Comments

    Interested persons may, on or before March 3, 1997, submit to the 
Dockets Management Branch (address above) written comments regarding 
this proposal. 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 office above between 9 
a.m. and 4 p.m., Monday through Friday.

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, it is 
proposed that 21 CFR part 892 be amended as follows:

PART 892--RADIOLOGY DEVICES

    1. The authority citation for 21 CFR part 892 continues to read as 
follows:

    Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j, 
371).

    2. New Secs. 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. 
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 only when the device stores images without performing 
irreversible data compression.


Sec. 892.2020  Medical image communications device.

    (a) Identification. A medical image communications device provides 
electronic transfer of medical image data between medical devices. 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 only when the device transfers images without performing 
irreversible data compression.


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 systems employing video frame grabbers, and scanners which use 
lasers or charge-coupled devices.
    (b) Classification. Class II.


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.


Sec. 892.2050  Picture archiving and communications system.

    (a) 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.

    Dated: November 17, 1996.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 96-30650 Filed 11-29-96; 8:45 am]
BILLING CODE 4160-01-F