Devices: General Hospital and Personal Use Devices; Reclassification of Medical Device Data System, 7498-7503 [E8-2325]
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Federal Register / Vol. 73, No. 27 / Friday, February 8, 2008 / Proposed Rules
Autopilot ................................................................................................................................................................................. Disengage.
Power Levers ........................................................................................................................................................................... As required.
Elevator Trim Wheels ............................................................................................................................................................. As required.
CAUTION: MANUALLY SET THE ELEVATOR TRIM WHEELS TO THE REQUIRED DESCENT ATTITUDE.
If any trim system binding (if trim wheel rotates more than one trim wheel index mark after being released), or abnormal trim operation is
observed:
Elevator Trim Jamming Procedure ................................................................................................................................. Perform.
CAUTION: DO NOT TRY TO RE-ENGAGE THE AUTOPILOT.
If no abnormal trim operation is observed:
Flight Director Vertical Mode ......................................................................................................................................... As required.
Autopilot .......................................................................................................................................................................... Reengage.
‘‘(2) If an elevator trim jamming is detected during flight and the pitch trim system resumes normal operation on ground, only a ferry
flight using a special permit may be performed to return the aircraft to a maintenance base for replacement of the actuators. In this case,
the use of autopilot is prohibited.’’
Placard Installation
(c) Within 300 flight hours after the
effective date of this AD, install two placards
on the glareshield, advising the flight crew to
check the pitch trim before initial descent, in
accordance with Part II of the
Accomplishment Instructions of EMBRAER
Service Bulletin 120–25–0262, Change 02,
dated October 30, 2003.
Elevator Trim System Modification
(d) Within 36 months after the effective
date of this AD, modify the elevator trim
system, in accordance with the
Accomplishment Instructions of EMBRAER
Service Bulletin 120–27–0095 and 120–27–
0096, both dated February 16, 2007.
Accomplishment of the modification
terminates the requirements of paragraphs
(a), (b), and (c) of this AD, and the
corresponding AFM revisions and placards
may be removed.
Parts Installation
(e) As of 36 months after the effective date
of this AD, no person may install, on any
airplane, an elevator trim tab actuator or
control cable having a part number identified
in Table 1 of this AD.
Elevator trim tab actuator ..
120–19685–001
120–19685–003
120–19685–007
120–38650–001
120–39205–001
5299
5299–1
120–27729–095
120–27729–097
120–31370–095
120–31370–097
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Alternative Methods of Compliance
(f)(1) The Manager, International Branch,
ANM–116, Transport Airplane Directorate,
FAA, has the authority to approve AMOCs
for this AD, if requested in accordance with
the procedures found in 14 CFR 39.19.
(2) To request a different method of
compliance or a different compliance time
for this AD, follow the procedures in 14 CFR
39.19. Before using any approved AMOC on
any airplane to which the AMOC applies,
notify your appropriate principal inspector
(PI) in the FAA Flight Standards District
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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
ACTION:
Part No.
14:33 Feb 07, 2008
BILLING CODE 4910–13–P
Food and Drug Administration,
HHS.
Part
VerDate Aug<31>2005
Issued in Renton, Washington, on February
1, 2008.
Ali Bahrami,
Manager, Transport Airplane Directorate,
Aircraft Certification Service.
[FR Doc. E8–2356 Filed 2–7–08; 8:45 am]
AGENCY:
TABLE 1.—PROHIBITED PARTS
Control cable ......................
Office (FSDO), or lacking a PI, your local
FSDO.
Note 1: The subject of this AD is addressed
in Brazilian airworthiness directive 2001–06–
01R4, effective August 23, 2007.
Proposed rule.
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
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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: https://
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 email. 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 https://
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 https://
www.regulations.gov and insert the
docket number(s), found in brackets in
the heading of this document, into the
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‘‘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:
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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
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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
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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 computerbased 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 softwarebased 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 softwarebased 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 CO2 levels to
a central patient data repository;
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• 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
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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
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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 § 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 § 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 (§ 820.30) of the QS
regulation (§ 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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IX. Environmental Impact
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.
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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,
§ 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.
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 1year expenditure that would meet or
exceed this amount.
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.
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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
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
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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 § 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 complainthandling 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
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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
PO 00000
Frm 00021
Fmt 4702
Sfmt 4702
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
E:\FR\FM\08FEP1.SGM
08FEP1
Federal Register / Vol. 73, No. 27 / Friday, February 8, 2008 / Proposed Rules
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
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 § 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
7503
5203, Internal Revenue Service, PO Box
7604, Ben Franklin Station, Washington,
DC 20044. Submissions may be hand
delivered Monday through Friday
between the hours of 8 a.m. and 4 p.m.
to: CC:PA:LPD:PR (REG–153589–06),
Courier’s Desk, Internal Revenue
Service, 1111 Constitution Avenue,
NW., Washington, DC, or sent
electronically via the Federal
eRulemaking Portal at
www.regulations.gov (IRS REG–
153589–06).
FOR FURTHER INFORMATION CONTACT:
Concerning the proposed regulation,
Jamie Kim, (202) 622–4950; concerning
submission of comments or requesting a
hearing, Richard.A.Hurst@irscounsel.
treas.gov, (202) 622–7180 (not toll-free
numbers).
DEPARTMENT OF THE TREASURY
SUPPLEMENTARY INFORMATION:
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 371.
Internal Revenue Service
Background and Explanation of
Provisions
2. Part 880 is amended in subpart G
by adding § 880.6310 to read as follows:
26 CFR Part 1
§ 880.6310
ebenthall on PRODPC61 with PROPOSALS
1. The authority citation for 21 CFR
part 880 continues to read as follows:
RIN 1545–BG34
Temporary regulation in the Rules
and Regulations section of this issue of
the Federal Register amends the Income
Tax Regulations (26 CFR part 1) relating
to section 1221(b)(3) of the Internal
Revenue Code (Code). The temporary
regulation provides rules regarding the
time and manner for making an election
under section 1221(b)(3) to treat the sale
or exchange of certain musical
compositions or copyrights in musical
works as the sale or exchange of a
capital asset. The text of the temporary
regulation also serves as the text of this
proposed regulation. The preamble to
the temporary regulation explains the
amendments.
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
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[REG–153589–06]
Time and Manner for Electing Capital
Asset Treatment for Certain SelfCreated Musical Works
Internal Revenue Service (IRS),
Treasury.
ACTION: Notice of proposed rulemaking
by cross-reference to temporary
regulation.
AGENCY:
SUMMARY: In the Rules and Regulations
section of this issue of the Federal
Register, the IRS is issuing a temporary
regulation that provides the time and
manner for making an election to treat
the sale or exchange of musical
compositions or copyrights in musical
works created by the taxpayer (or
received by the taxpayer from the
works’ creator in a transferred basis
transaction) as the sale or exchange of
a capital asset. The temporary regulation
reflects changes to the law made by the
Tax Increase Prevention and
Reconciliation Act of 2005 and the Tax
Relief and Health Care Act of 2006. The
temporary regulation affects taxpayers
making the election under section
1221(b)(3) of the Internal Revenue Code
(Code) to treat gain or loss from such a
sale or exchange as capital gain or loss.
The text of the temporary regulation
also serves as the text of this proposed
regulation.
DATES: Written or electronic comments
and requests for a public hearing must
be received by May 8, 2008.
ADDRESSES: Send submissions to:
CC:PA:LPD:PR (REG–153589–06), room
PO 00000
Frm 00022
Fmt 4702
Sfmt 4702
Special Analyses
It has been determined that this notice
of proposed rulemaking is not a
significant regulatory action as defined
in Executive Order 12866. Therefore, a
regulatory assessment is not required. It
also has been determined that section
553(b) of the Administrative Procedure
Act (5 U.S.C. chapter 5) does not apply
to this regulation, and because the
regulation does not impose a collection
of information on small entities, the
Regulatory Flexibility Act (5 U.S.C.
chapter 6) does not apply. Pursuant to
section 7805(f) of the Internal Revenue
Code, this regulation has been
submitted to the Chief Counsel for
Advocacy of the Small Business
Administration for comment on its
impact on small business.
Comments and Requests for a Public
Hearing
Before this proposed regulation is
adopted as a final regulation,
consideration will be given to any
E:\FR\FM\08FEP1.SGM
08FEP1
Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://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 https://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 https://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
[[Page 7501]]
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