[Federal Register Volume 73, Number 27 (Friday, February 8, 2008)]
[Proposed Rules]
[Pages 7498-7503]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-2325]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 880
[Docket No. 2007N-0484]
Devices: General Hospital and Personal Use Devices;
Reclassification of Medical Device Data System
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to
reclassify, on its own initiative, the Medical Device Data System
(MDDS) from class III (premarket approval) to class I (general
controls). This action does not include medical device data systems
with new diagnostic or alarm functions. FDA is also proposing that the
MDDS be exempt from the premarket notification requirements when it is
indicated for use only by a healthcare professional and does not
perform irreversible data compression.
DATES: Submit written or electronic comments on the proposed rule by
May 8, 2008. Submit comments regarding information collection by March
10, 2008, to the Office of Management and Budget (OMB) (see ADDRESSES).
FDA proposes that any final regulation based on this proposal become
effective 60 days after its date of publication in the Federal
Register. See section VIII of the SUPPLEMENTARY INFORMATION section of
the preamble for further information about the effective date.
ADDRESSES: You may submit comments, identified by Docket No. 2007N-
0484, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the followings ways:
FAX: 301-827-6870.
Mail/Hand delivery/Courier (For paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal or the agency Web site, as described previously, in
the ADDRESSES portion of this document under Electronic Submissions.
Instructions: All submissions received must include the agency name
and Docket No.(s) and Regulatory Information Number (RIN) (if a RIN
number has been assigned) for this rulemaking. All comments received
may be posted without change to http://www.regulations.gov, including
any personal information provided. For additional information on
submitting comments, see the ``Comments'' heading of the SUPPLEMENTARY
INFORMATION section of this document.
Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number(s), found in brackets in the heading of this document,
into the
[[Page 7499]]
``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Information Collection Provisions: Submit written comments on the
information collection provisions to the Office of Information and
Regulatory Affairs, OMB. To ensure that comments on the information
collection are received, OMB recommends that written comments be faxed
to the Office of Information and Regulatory Affairs, OMB, Attn: FDA
Desk Officer, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Anthony D. Watson, Center for Devices
and Radiological Health (HFZ-480), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 240-276-3700.
SUPPLEMENTARY INFORMATION:
I. Background (Regulatory Authorities)
The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301
et seq.), as amended by the Medical Device Amendments of 1976 (the 1976
amendments) (Public Law 94-295), the Safe Medical Devices Act of 1990
(SMDA) (Public Law 101-629), and the Food and Drug Administration
Modernization Act of 1997 (FDAMA) (Public Law 105-115), established a
comprehensive system for the regulation of medical devices intended for
human use. Section 513(a)(1) of the act (21 U.S.C. 360c) established
three categories (classes) of devices, depending on the regulatory
controls needed to provide reasonable assurance of their safety and
effectiveness. The three categories of devices are:
Class I (general controls),
Class II (special controls), and
Class III (premarket approval).
FDA refers to devices that were in commercial distribution before
May 28, 1976 (the date of enactment of the 1976 amendments), as
``preamendment devices.'' FDA classifies these devices after it:
1. Receives a recommendation from a device classification panel (an
FDA advisory committee);
2. Publishes the panel's recommendation for comment, along with a
proposed regulation classifying the device; and
3. Publishes a final regulation classifying the device.
FDA has classified most preamendments devices under these
procedures.
The agency determines whether new devices are substantially
equivalent to predicate devices by means of premarket notification
procedures in section 510(k) of the act (21 U.S.C. 360(k)) and part 807
of the regulations (21 CFR part 807).
Reclassification of postamendment devices is governed by section
513(f)(3) of the act, formerly section 513(f)(2) of the act. This
section provides that FDA may initiate the reclassification of a device
classified into class III under section 513(f)(1) of the act, or the
manufacturer or importer of a device may petition the Secretary of
Health and Human Services for the issuance of an order classifying the
device in class I or class II. FDA's regulations in 21 CFR 860.134 set
forth the procedures for the filing and review of a petition for
reclassification of such class III devices. In order to change the
classification of the device, it is necessary that the proposed new
classification have sufficient regulatory controls to provide
reasonable assurance of the safety and effectiveness of the device for
its intended use.
FDAMA added section 510(l) to the act. Section 510(l) of the act
provides that a class I device is exempt from the premarket
notification requirements under section 510(k) of the act, unless the
device is intended for a use which is of substantial importance in
preventing impairment of human health or it presents a potential
unreasonable risk of illness or injury. FDA refers to the criteria that
designate a class I device as not exempt from premarket notification as
``reserved criteria.'' An exemption permits manufacturers to introduce
into commercial distribution generic types of devices without first
submitting a premarket notification to FDA.
II. Regulatory History of the Device
Computer-based and software-based products are subject to
regulation as devices when they meet the definition of a device
contained in section 201(h) of the act (21 U.S.C. 321(h)). In 1989, FDA
prepared a general policy statement on how it planned to determine
whether a computer-based product and/or software based product is a
device and, if so, how FDA intended to regulate it. This document
became known as the ``Draft Software Policy.'' The scope and intention
of the 1989 policy were based on the existing state of computer and
software technology at that time. That policy included the principle
that the level of FDA oversight of software should depend primarily on
the risk to the patient should the software fail to perform in
accordance with its specifications.
Since 1989, the use of computer-based products and software-based
products as medical devices has grown exponentially. In addition,
device interconnectivity and complexity have grown in ways that could
not have been predicted in 1989. This growth and expansion have created
new considerations for elements of risk that did not previously exist.
FDA realized that the Draft Software Policy was not adequate to address
all of the issues related to the regulation of computer-based and
software-based medical devices. Based on this history and the
complexity and diversity of computer software, FDA decided it would be
impractical to prepare one ``software'' or ``computer'' policy that
would be able to address all the issues related to the regulation of
computer- and software-based medical devices. Nonetheless, the
principle that the level of FDA oversight of software should depend
primarily on the risk to the patient should the software fail to
perform in accordance with its specifications remains important. Many
software classifications reflect this principle, including:
FDA has classified software used in computer aided
detection of cancerous lesions in the breast in class III;
FDA has classified software used in computer tomography
(CT) and X-ray systems to provide images to assist in clinical
decisionmaking in class II; and
FDA has classified laboratory information systems in class
I.
This principle also informs this proposed reclassification, in
which FDA is focusing on a category of post amendment computer- and
software-based devices that present a low risk and should not be
subject to premarket review that have not been classified elsewhere. An
examination of modern medical device networks and computer
infrastructure helped FDA to identify a category of computer based and
software products that meet the definition of a device, which the FDA
would consider to pose minimal risks, and that should not be Class III
and should not require premarket submission. This medical device has
been named a ``Medical Device Data System.''
III. Device Description
A medical device data system (MDDS) is a device intended to provide
one or more of the following uses:
The electronic transfer or exchange of medical device data
from a medical device, without altering the function or parameters of
any connected devices. For example, this would include software that
interrogates a ventilator every 15 minutes and transfers information
about patient CO\2\ levels to a central patient data repository;
[[Page 7500]]
The electronic storage and retrieval of medical device
data, without altering the function or parameters of connected devices.
For example, this would include software that stores historical blood
pressure information for later review by a healthcare provider;
The electronic display of medical device data, without
altering the function or parameters of connected devices. For example,
this would include software that displays the previously stored
electrocardiogram for a particular patient;
The electronic conversion of medical device data from one
format to another format in accordance with a preset specification. For
example, this would include software that converts digital data
generated by a pulse oximeter into a digital format that can be
printed.
Examples of medical device data systems that would be used
in the home are systems that periodically collect data from glucose
meters or blood pressure devices for later review by a healthcare
provider.
Medical device data consist of numerical or other information
available from a medical device in a form suitable for processing by
computer. Medical device data can represent many types of information
(e.g., clinical values, alarm conditions, error messages). MDDS are not
intended or designed to provide any real time, active, or online
patient monitoring functions. Medical device data systems can deliver
and store alarm data but do not have the capability to display, create,
or detect alarm conditions, or to actually sound an alarm. In
particular, a MDDS can record the fact that an alarm sounded, but
cannot by itself sound an alarm in response to patient information.
Medical device data systems cannot create alarms that are not already
present from the connected medical devices. By themselves, MDDS do not
provide any diagnostic or clinical decision making functions. Medical
device data systems can transmit, exchange, store, or retrieve data in
its original format or can be used to convert the medical device data
from one format to another so that the arrangement or organization of
the medical device data is in accordance with preset specifications.
In developing its current regulatory strategy for MDDS, FDA
considered how the risks presented by an MDDS compare to existing
manual processes for managing these data. Hospitals, clinics, and other
healthcare facilities are well-aware of the shortcomings of manual
functions and have introduced other manual oversight to reduce their
effects, such as audits of records and multiple-person checks of
paperwork prior to treatments. These facilities have also introduced
electronic systems to help reduce the human element in these errors.
However, when data are being stored, retrieved, transferred, exchanged,
or displayed electronically, an additional element of risk is
introduced. This element of risk would not be present for a manual
transfer of files or information because the information is readily
apparent to the healthcare provider.
When manual data is converted to electronic form, data can be
altered in such a way as to not be transparent to the user and pose a
risk to the patient. In effect, even though manual functions have their
risks (e.g., illegible handwriting, wrong charts, etc.), when these
functions are automated, users tend to rely entirely on the technology
because the technology is assumed to alleviate those risks. This is
especially true when software systems are designed to interface with a
number of unspecified medical devices. Thus, regulatory oversight of
MDDS is critical to ensuring that there is an adequate expectation of
performance.
It is FDA's long-standing practice to not regulate those manual
office functions that are simply automated for the ease of the user
(e.g., office automation) and that do not include MDDS as described
previously. For example, the report-writing functions of a computer
system that allow for the manual (typewriter like) input of data by
practitioners would not be considered as a MDDS, because these systems
are not directly connected to a medical device. In addition, software
that merely performs library functions, such as storing, indexing, and
retrieving information not specific to an individual patient, is not
considered to be a medical device. Examples include medical texts or
the Physician's Desk Reference on CD-ROM that are indexed and cross-
referenced for ease of use. This proposed regulation does not address
software that allows a doctor to enter or store a patient's health
history in a computer file.
IV. Proposed Reclassification
Because MDDS that are subject to the rulemaking are new post
amendment devices, they are deemed to be class III by operation of the
statute (section 513(f) of the act (21 U.S.C. 360c(f)). FDA believes
that classification in class I, with appropriate application of the
Quality System Regulation (part 820 (21 CFR part 820)), will provide
reasonable assurance of the safety and effectiveness of this device.
FDA is proposing that the Medical Device Data System be reclassified
from class III to class I. In addition, FDA is proposing that when the
device is indicated for use only by a healthcare professional and does
not perform irreversible data compression, in accordance with section
510(l) of the act (21 U.S.C. 360(l)), it would be exempt from the
premarket notification procedures in subpart E of part 807, subject to
the limitations in Sec. 880.9 (21 CFR 880.9). For purposes of this
regulation, ``healthcare professional'' is any practitioner licensed by
the law of the State in which he or she practices to use or order the
use of the device. When the device is indicated for use by a lay user,
or performs irreversible data compression, FDA believes that the device
presents a potential for unreasonable risk of illness or injury. FDA is
proposing that MDDS devices indicated for lay use or that perform
irreversible data compression not be exempt from premarket notification
requirements.
V. Risks to Health
FDA believes that general controls, including the Quality System
regulation and the requirements for Design Controls as per Sec.
820.30, will provide a reasonable assurance of safety and effectiveness
for a MDDS. Risks to health from this device would be caused by
inadequate software quality. Specifically, the risk to health would be
that incorrect medical device data is stored, retrieved, transferred,
exchanged, or displayed, resulting in incorrect treatment or diagnosis
of the patient. As explained below, FDA believes the risk related to
inadequate software quality can be mitigated through application of the
Quality System Regulation.
VI. Summary of Reasons for Reclassification
FDA believes that the MDDS should be reclassified into class I
because general controls would provide reasonable assurance of safety
and effectiveness and special controls and premarket approval are not
necessary to provide such assurance. FDA believes that the application
of the Quality System Regulation (part 820), particularly the design
control provisions, would significantly reduce the risk of errors from
these devices that might cause incorrect treatment or diagnosis of the
patient. The design controls section (Sec. 820.30) of the QS
regulation (Sec. 820.30) applies to the design of devices including
class I devices with software. FDA does not intend to apply design
controls retroactively to currently legally
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marketed MDDS devices. However, changes to existing designs or to
currently marketed devices must be made in accordance with design
control requirements, even if the original design was not subject to
these requirements, Sec. 820.30. This approach to implementing design
controls for MDDS is consistent with the way FDA implemented design
controls after the issuance of the Quality System Regulation in 1996.
VII. Summary of Data Upon Which the Reclassification is Based
FDA is basing this proposed rule upon the history of use of this
type of device in clinical practice as well as the substantial
knowledge of FDA staff about this device type. These types of systems
provide no new or unique clinical algorithms or clinical functions that
have not already been reviewed and cleared in existing medical devices;
therefore, no new pre-market review or evaluation should be required.
Further, FDA believes that the proper application of a Quality System
approach to the design and development of MDDS devices will ensure
their quality. FDA believes that this is the least burdensome approach
to the regulation of these medical devices.
VIII. Effective Date
FDA intends that this rule, if finalized, will become effective 60
days after the date of publication of the final rule. However, FDA
intends to continue to exercise enforcement discretion after
publication of any final rule so that manufacturers who are already on
the market with MDDS devices may have sufficient time to come into
compliance as follows: FDA expects manufacturers who are already
marketing a MDDS device before publication of a final rule and who meet
the criteria for exemption from premarket notification to register and
list under part 807 within 60 days after publication of the final rule.
If a premarket notification is required, FDA expects manufacturers who
are marketing an MDDS device without FDA clearance to submit a
premarket notification within 90 days of the effective date of a final
rule and to obtain final clearance of a premarket notification within
180 days after publication of a final rule. FDA expects manufacturers
who are required to obtain clearance of a premarket notification to
register and list within 30 days after receiving a substantial
equivalence order for their device. Manufacturers who are not already
marketing an MDDS device will be required to comply with any final rule
as of the effective date.
IX. Environmental Impact
The agency has determined under 21 CFR 25.34(b) that this proposed
reclassification 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.
X. Analysis of Impact
FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public Law 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 proposed rule is not a significant regulatory action as defined by
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 this action is deregulatory and imposes no
new burdens, the agency certifies that the proposed rule will not have
a significant economic impact on a substantial number of small
entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $127 million, using the most current (2006) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule to result in any 1-year expenditure that would meet or
exceed this amount.
Background
An MDDS is a device that electronically stores, transfers,
displays, or reformats patient medical data. It does not provide any
diagnostic or clinical decision making functions. A MDDS could, for
example, store alarm data being generated by a connected medical
device, but would not be able to generate alarms on its own. The MDDS
device is currently classified into class III, the highest level of
regulatory oversight. The MDDS was initially placed in this
classification by default. MDDS manufacturers, as makers of class III
devices, bear all costs associated with premarket approval, including
the cost of submitting the premarket approval application (PMA) and
payment of user fees. The costs associated with the submission of the
PMA are substantial, potentially reaching $1,000.000.
Although we can identify several MDDS devices and device
manufacturers, we nevertheless do not know the size of the affected
industry because FDA has not been enforcing registration and listing
requirements for manufacturers of MDDS devices. We welcome comment on
the size and other characteristics of the affected industry.
FDA is proposing to reclassify MDDS devices from class III to class
I. Based on the history of use of this type of device in clinical
practice and on the experience of FDA reviewers, the agency concludes
that in the hands of a healthcare professional, a MDDS is safe and
effective under general controls. The application of general controls,
including the software design controls in part 820, would be consistent
with the principle of applying the least degree of regulatory control
necessary to provide reasonable assurance of safety and effectiveness.
The application of this lowest level of regulatory oversight would be
consistent with the treatment of other devices with similar risk
profiles. Software used to store, transmit, and communicate patient
medical data, such as Laboratory Information Systems and Medical Image
Communication Systems, is typically classified into class I.
FDA has already recognized that the class III requirements are not
necessary for ensuring the safety and effectiveness of MDDS devices and
has been exercising enforcement discretion with MDDS device
manufacturers. These firms have not been required to submit PMAs or
meet other requirements typically required of manufacturers of class
III devices, but the agency believes that all or nearly all firms in
this industry have in place good business practices, including quality
systems. If FDA were to discontinue enforcement discretion, most firms
would continue to comply with the class I provisions.
Cost of the Proposed Regulation
This proposed regulation is deregulatory. Device manufacturers
currently subject to class III requirements would be subject to the
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less burdensome requirements for makers of class I devices. Of course,
changing the device classification may not have an impact on the
practices of MDDS device manufacturers as long as FDA continues its
practice of enforcement discretion. For the purpose of this analysis,
however, we assume that enforcement discretion would not be permanent.
The regulatory alternatives are therefore class III, II, or I controls,
enforced by the agency. This proposed rule would re-classify MDDS
devices as class I, which would reduce the applicable regulatory
requirements.
Manufacturers of class I devices are required to: (1) Register and
list their MDDS devices with the agency, (2) conform to applicable
medical device current good manufacturing practice requirements (part
820), (3) comply with Medical Device Reporting (MDR) requirements (21
CFR part 803), and (4) submit a premarket notification for the device
unless it is exempt. This proposed rule proposes to exempt MDDS devices
unless they are indicated for use by someone other than a healthcare
professional, perform irreversible data compression, or exceed the
limitations in Sec. 880.9. MDDS devices indicated for use solely by a
healthcare professional, are exempt from the premarket notification
requirements.
Registration and listing. The majority of manufacturers of MDDS
devices would incur a cost to register and list their devices with the
agency. We estimate this burden to be less than 1 hour per year for
manufacturers familiar with this requirement, and up to 2 hours of time
for manufacturers not currently producing any FDA-regulated devices.
Manufacturers would also face user fees of $1,708 in fiscal year (FY)
2008 to register and list their devices with the agency. These fees
would rise to $2,364 in 2012.
Current Good Manufacturing Practices (CGMP)/Quality System
Regulation (QSR) compliance/Medical Device Reporting. Based on
experience with this and similar devices, FDA believes that most
manufacturers of these devices already have quality systems in place as
part of good business practices. Good quality systems would include
complaint-handling procedures. FDA's QSR (part 820) requirements are
very flexible and FDA believes that these manufacturers will be able to
conform their systems to FDA requirements with little difficulty or
cost. Manufacturers are already required to report to FDA whenever they
learn that their device may have caused or contributed to a death or
serious injury to a patient. The cost of complying with these
requirements would be small, but would vary depending on the number and
nature of the devices manufactured and the nature of the firm's current
quality system. Firms with existing quality systems should be able to
adapt their complaint procedures to incorporate MDR reporting with
little difficulty. Based on our understanding of the industry and that
it has in place measures to ensure quality, we believe most firms would
be able to adapt their systems to meet FDA's QSR and MDR regulations
for no more than $20,000. Again, this would not be a cost imposed by
this proposed rule, but the cost of an existing burden manufacturers
may not have incurred because FDA's practice of enforcement discretion
with manufacturers of MDDS devices.
Premarket notification. If FDA finalizes the classification of MDDS
devices into class I, a manufacturer of a MDDS device that is indicated
for use solely in a health care facility would not need to comply with
the PMA requirement that applies to class III devices or submit a
premarket notification. FDA is unaware of any MDDS devices that are not
intended for use solely by healthcare professionals, so we believe all
or nearly all MDDS devices will be exempt from premarket review. A
manufacturer of a MDDS device that is indicated for use by anyone other
than a healthcare professional or that performs irreversible data
compression would need to submit a premarket notification, but the
burden of submitting a premarket notification is substantially less
than that of submitting a PMA. A premarket notification for a MDDS
device would be far less complex than a PMA. The cost of preparing and
submitting such a notification would be several thousand dollars. The
user fees for a premarket notification would be $3,404 for FY 2008,
increasing to $4,717 in 2012. In contrast, the cost of submitting a PMA
can reach $1,000,000, plus user fees of an additional $185,000 in FY
2008, increasing to $256,384 in 2012.
In summary, this device reclassification would substantially reduce
an existing burden on the manufacturers of MDDS devices. The regulatory
burden of compliance with the general controls provisions applicable to
the manufacturers of all class I devices is attributable to statutory
requirements that already apply but have not been enforced. Assuming
that continued enforcement discretion is not a viable long-term
regulatory alternative, the proposed rule would reduce the regulatory
burden for manufacturers of MDDS devices. Considering the cost of
submitting a PMA plus the relevant user fees, the reduction could be
$1,000,000 per device.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because reclassification of the affected devices
from class III to class I would relieve manufacturers of the cost of
complying with the premarket approval requirements of section 515 of
the act (21 U.S.C. 360e), the agency does not believe that this
proposed rule would have a significant economic impact on a substantial
number of small entities. FDA requests comment on this issue.
XI. Paperwork Reduction Act of 1995
This proposed rule contains information collection provisions that
are subject to review by OMB under the Paperwork Reduction Act of 1995
(the PRA) (44 U.S.C. 3501-3520). The collections of information
addressed in the proposed rule have been approved by OMB in accordance
with the PRA under the QSR (part 820, OMB Control No. 0910-0073) and
the regulations governing premarket notification submissions (21 CFR
part 807, subpart E, OMB Control No. 0910-0120).
XII. Federalism
FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the proposed rule, if finalized, would not contain policies that would
have substantial direct effects on the States, on the relationship
between the National Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
Accordingly, the agency tentatively concludes that the proposed rule
does not contain policies that have federalism implications as defined
in the Executive order and, consequently, a federalism summary impact
statement has not been prepared.
XIII. Submission of Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper 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
Division
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of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Please note that on January 15, 2008, the FDA Web site transitioned
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will
be accepted by FDA through FDMS only.
List of Subjects in 21 CFR Part 880
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, FDA proposes
to amend 21 CFR part 880 as follows:
PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES
1. The authority citation for 21 CFR part 880 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
2. Part 880 is amended in subpart G by adding Sec. 880.6310 to
read as follows:
Sec. 880.6310 Medical Device Data System.
(a) Identification. (1) A medical device data system (MDDS) is a
device intended to provide one or more of the following uses:
(i) The electronic transfer or exchange of medical device data from
a medical device, without altering the function or parameters of any
connected devices.
(ii) The electronic storage and retrieval of medical device data
from a medical device, without altering the function or parameters of
connected devices.
(iii) The electronic display of medical device data from a medical
device, without altering the function or parameters of connected
devices.
(iv) The electronic conversion of medical device data from one
format to another format in accordance with a preset specification.
(2) Medical device data consists of numerical or other information
available from a medical device in a form suitable for processing by
computer. Medical device data can represent any type of information or
knowledge, e.g., clinical values, alarm conditions, error messages.
This identification does not include a device that creates diagnostic,
decision support, or alarm functions. It also does not include the
report-writing functions of a data system that allows for the manual
input of data by practitioners. This identification does not include
devices with any real time, active, or online patient monitoring.
(b) Classification. Class I (general controls). When the device is
indicated for use only by a healthcare professional and does not
perform irreversible data compression, it is exempt from the premarket
notification procedures in subpart E of part 807, subject to the
limitations in Sec. 880.9. When the device is indicated to be
prescribed by a healthcare professional for use by a lay user, or
performs irreversible data compression, or for over-the-counter use by
a lay user, the device requires the submission and clearance of a
premarket notification.
Dated: January 25, 2008.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E8-2325 Filed 2-7-08; 8:45 am]
BILLING CODE 4160-01-S