Source: https://www.scribd.com/document/33753171/Proposed-FDA-Regulation-of-Medical-Device-Data-Systems
Timestamp: 2019-11-22 18:37:12
Document Index: 568820422

Matched Legal Cases: ['art 880', 'art 807', 'art 807', 'art 807', '§ 880', '§ 820', 'art 820', '§ 820', '§ 820', 'art 820', 'art 820', '§ 820', 'art 820', 'art 807', 'art 820', 'art 803', 'art 820', '§ 880', 'art 807', 'art 807', '§ 880', 'art 880', 'ART 880', 'art 880', 'art 880', 'art 1', '§ 880', '§ 880', 'art 1']

Proposed FDA Regulation of Medical Device Data Systems | Medical Device | Federal Food
FDA proposes to regulate medical device data systems as class one devices because the growth and expansion of software systems have “create new considerations for elements of risk that did not previously exist.”
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7498 Federal Register / Vol. 73, No.
27 / Friday, February 8, 2008 / Proposed Rules
Autopilot ................................................................................................................................................................................. Disengage.
Power Levers ........................................................................................................................................................................... As required.
Elevator Trim Wheels ............................................................................................................................................................. As required.
If any trim system binding (if trim wheel rotates more than one trim wheel index mark after being released), or abnormal trim operation is
Elevator Trim Jamming Procedure ................................................................................................................................. Perform.
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 Office (FSDO), or lacking a PI, your local Federal Register. See section VIII of the
(c) Within 300 flight hours after the FSDO. SUPPLEMENTARY INFORMATION section of
effective date of this AD, install two placards Note 1: The subject of this AD is addressed the preamble for further information
on the glareshield, advising the flight crew to in Brazilian airworthiness directive 2001–06– about the effective date.
check the pitch trim before initial descent, in 01R4, effective August 23, 2007.
accordance with Part II of the
Accomplishment Instructions of EMBRAER Issued in Renton, Washington, on February identified by Docket No. 2007N–0484,
Service Bulletin 120–25–0262, Change 02, 1, 2008. by any of the following methods:
dated October 30, 2003. Ali Bahrami,
Elevator Trim System Modification Manager, Transport Airplane Directorate,
Aircraft Certification Service. Submit electronic comments in the
(d) Within 36 months after the effective following way:
[FR Doc. E8–2356 Filed 2–7–08; 8:45 am]
date of this AD, modify the elevator trim • Federal eRulemaking Portal: http://
system, in accordance with the BILLING CODE 4910–13–P
Accomplishment Instructions of EMBRAER instructions for submitting comments.
Service Bulletin 120–27–0095 and 120–27–
0096, both dated February 16, 2007. DEPARTMENT OF HEALTH AND Written Submissions
Accomplishment of the modification HUMAN SERVICES
terminates the requirements of paragraphs Submit written submissions in the
(a), (b), and (c) of this AD, and the followings ways:
Food and Drug Administration • FAX: 301–827–6870.
corresponding AFM revisions and placards
may be removed. • Mail/Hand delivery/Courier (For
21 CFR Part 880 paper, disk, or CD-ROM submissions):
[Docket No. 2007N–0484] Division of Dockets Management (HFA–
(e) As of 36 months after the effective date 305), Food and Drug Administration,
of this AD, no person may install, on any Devices: General Hospital and 5630 Fishers Lane, rm. 1061, Rockville,
airplane, an elevator trim tab actuator or
control cable having a part number identified Personal Use Devices; Reclassification MD 20852.
in Table 1 of this AD. of Medical Device Data System To ensure more timely processing of
AGENCY: Food and Drug Administration, comments submitted to the agency by e-
TABLE 1.—PROHIBITED PARTS HHS. mail. FDA encourages you to continue
Part Part No. ACTION: Proposed rule. to submit electronic comments by using
Elevator trim tab actuator .. 120–19685–001 SUMMARY: The Food and Drug agency Web site, as described
120–19685–003 Administration (FDA) is proposing to previously, in the ADDRESSES portion of
120–19685–007 reclassify, on its own initiative, the this document under Electronic
120–38650–001 Medical Device Data System (MDDS) Submissions.
120–39205–001 from class III (premarket approval) to Instructions: All submissions received
5299 class I (general controls). This action
5299–1
does not include medical device data Docket No.(s) and Regulatory
Control cable ...................... 120–27729–095
systems with new diagnostic or alarm Information Number (RIN) (if a RIN
120–27729–097
120–31370–095 functions. FDA is also proposing that number has been assigned) for this
120–31370–097 the MDDS be exempt from the rulemaking. All comments received may
premarket notification requirements be posted without change to http://
Alternative Methods of Compliance when it is indicated for use only by a www.regulations.gov, including any
(f)(1) The Manager, International Branch, healthcare professional and does not personal information provided. For
ANM–116, Transport Airplane Directorate, perform irreversible data compression. additional information on submitting
FAA, has the authority to approve AMOCs DATES: Submit written or electronic comments, see the ‘‘Comments’’ heading
for this AD, if requested in accordance with comments on the proposed rule by May of the SUPPLEMENTARY INFORMATION
the procedures found in 14 CFR 39.19. 8, 2008. Submit comments regarding section of this document.
(2) To request a different method of information collection by March 10, Docket: For access to the docket to
compliance or a different compliance time
for this AD, follow the procedures in 14 CFR
2008, to the Office of Management and read background documents or
39.19. Before using any approved AMOC on Budget (OMB) (see ADDRESSES). FDA comments received, go to http://
any airplane to which the AMOC applies, proposes that any final regulation based www.regulations.gov and insert the
notify your appropriate principal inspector on this proposal become effective 60 docket number(s), found in brackets in
(PI) in the FAA Flight Standards District days after its date of publication in the the heading of this document, into the
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Federal Register / Vol. 73, No. 27 / Friday, February 8, 2008 / Proposed Rules 7499
‘‘Search’’ box and follow the prompts section 510(k) of the act (21 U.S.C. exponentially. In addition, device
and/or go to the Division of Dockets 360(k)) and part 807 of the regulations interconnectivity and complexity have
Management, 5630 Fishers Lane, rm. (21 CFR part 807). grown in ways that could not have been
1061, Rockville, MD 20852. Reclassification of postamendment predicted in 1989. This growth and
Information Collection Provisions: devices is governed by section 513(f)(3) expansion have created new
Submit written comments on the of the act, formerly section 513(f)(2) of considerations for elements of risk that
information collection provisions to the the act. This section provides that FDA did not previously exist. FDA realized
Office of Information and Regulatory may initiate the reclassification of a that the Draft Software Policy was not
Affairs, OMB. To ensure that comments device classified into class III under adequate to address all of the issues
on the information collection are section 513(f)(1) of the act, or the related to the regulation of computer-
received, OMB recommends that written manufacturer or importer of a device based and software-based medical
comments be faxed to the Office of may petition the Secretary of Health and devices. Based on this history and the
Information and Regulatory Affairs, Human Services for the issuance of an complexity and diversity of computer
OMB, Attn: FDA Desk Officer, FAX: order classifying the device in class I or software, FDA decided it would be
202–395–6974. class II. FDA’s regulations in 21 CFR impractical to prepare one ‘‘software’’ or
860.134 set forth the procedures for the ‘‘computer’’ policy that would be able to
Anthony D. Watson, Center for Devices filing and review of a petition for address all the issues related to the
and Radiological Health (HFZ–480), reclassification of such class III devices. regulation of computer- and software-
Food and Drug Administration, 9200 In order to change the classification of based medical devices. Nonetheless, the
Corporate Blvd., Rockville, MD 20850, the device, it is necessary that the principle that the level of FDA oversight
proposed new classification have of software should depend primarily on
240–276–3700.
sufficient regulatory controls to provide the risk to the patient should the
SUPPLEMENTARY INFORMATION: reasonable assurance of the safety and software fail to perform in accordance
I. Background (Regulatory Authorities) effectiveness of the device for its with its specifications remains
intended use. important. Many software classifications
The Federal Food, Drug, and Cosmetic FDAMA added section 510(l) to the
Act (the act) (21 U.S.C. 301 et seq.), as reflect this principle, including:
act. Section 510(l) of the act provides • FDA has classified software used in
amended by the Medical Device that a class I device is exempt from the
Amendments of 1976 (the 1976 computer aided detection of cancerous
amendments) (Public Law 94–295), the lesions in the breast in class III;
under section 510(k) of the act, unless
Safe Medical Devices Act of 1990 • FDA has classified software used in
the device is intended for a use which
(SMDA) (Public Law 101–629), and the computer tomography (CT) and X-ray
is of substantial importance in
Food and Drug Administration preventing impairment of human health systems to provide images to assist in
Modernization Act of 1997 (FDAMA) or it presents a potential unreasonable clinical decisionmaking in class II; and
(Public Law 105–115), established a risk of illness or injury. FDA refers to • FDA has classified laboratory
comprehensive system for the regulation the criteria that designate a class I information systems in class I.
of medical devices intended for human device as not exempt from premarket This principle also informs this
use. Section 513(a)(1) of the act (21 notification as ‘‘reserved criteria.’’ An proposed reclassification, in which FDA
U.S.C. 360c) established three categories exemption permits manufacturers to is focusing on a category of post
(classes) of devices, depending on the introduce into commercial distribution amendment computer- and software-
regulatory controls needed to provide generic types of devices without first based devices that present a low risk
reasonable assurance of their safety and submitting a premarket notification to and should not be subject to premarket
effectiveness. The three categories of FDA. review that have not been classified
devices are: elsewhere. An examination of modern
• Class I (general controls), II. Regulatory History of the Device medical device networks and computer
• Class II (special controls), and Computer-based and software-based infrastructure helped FDA to identify a
• Class III (premarket approval). products are subject to regulation as category of computer based and
FDA refers to devices that were in devices when they meet the definition software products that meet the
commercial distribution before May 28, of a device contained in section 201(h) definition of a device, which the FDA
1976 (the date of enactment of the 1976 of the act (21 U.S.C. 321(h)). In 1989, would consider to pose minimal risks,
amendments), as ‘‘preamendment FDA prepared a general policy and that should not be Class III and
devices.’’ FDA classifies these devices statement on how it planned to should not require premarket
after it: determine whether a computer-based submission. This medical device has
1. Receives a recommendation from a product and/or software based product been named a ‘‘Medical Device Data
device classification panel (an FDA is a device and, if so, how FDA intended System.’’
advisory committee); to regulate it. This document became III. Device Description
2. Publishes the panel’s known as the ‘‘Draft Software Policy.’’
recommendation for comment, along The scope and intention of the 1989 A medical device data system (MDDS)
with a proposed regulation classifying policy were based on the existing state is a device intended to provide one or
the device; and of computer and software technology at more of the following uses:
3. Publishes a final regulation that time. That policy included the • The electronic transfer or exchange
classifying the device. principle that the level of FDA oversight of medical device data from a medical
FDA has classified most of software should depend primarily on device, without altering the function or
preamendments devices under these the risk to the patient should the parameters of any connected devices.
procedures. software fail to perform in accordance For example, this would include
The agency determines whether new with its specifications. software that interrogates a ventilator
devices are substantially equivalent to Since 1989, the use of computer-based every 15 minutes and transfers
predicate devices by means of products and software-based products information about patient CO2 levels to
premarket notification procedures in as medical devices has grown a central patient data repository;
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7500 Federal Register / Vol. 73, No. 27 / Friday, February 8, 2008 / Proposed Rules
• The electronic storage and retrieval effects, such as audits of records and Medical Device Data System be
of medical device data, without altering multiple-person checks of paperwork reclassified from class III to class I. In
the function or parameters of connected prior to treatments. These facilities have addition, FDA is proposing that when
devices. For example, this would also introduced electronic systems to the device is indicated for use only by
include software that stores historical help reduce the human element in these a healthcare professional and does not
blood pressure information for later errors. However, when data are being perform irreversible data compression,
review by a healthcare provider; stored, retrieved, transferred, in accordance with section 510(l) of the
• The electronic display of medical exchanged, or displayed electronically, act (21 U.S.C. 360(l)), it would be
device data, without altering the an additional element of risk is exempt from the premarket notification
function or parameters of connected introduced. This element of risk would procedures in subpart E of part 807,
devices. For example, this would not be present for a manual transfer of subject to the limitations in § 880.9 (21
include software that displays the files or information because the CFR 880.9). For purposes of this
previously stored electrocardiogram for information is readily apparent to the regulation, ‘‘healthcare professional’’ is
a particular patient; healthcare provider. any practitioner licensed by the law of
• The electronic conversion of When manual data is converted to the State in which he or she practices
medical device data from one format to electronic form, data can be altered in to use or order the use of the device.
another format in accordance with a such a way as to not be transparent to When the device is indicated for use by
preset specification. For example, this the user and pose a risk to the patient. a lay user, or performs irreversible data
would include software that converts In effect, even though manual functions compression, FDA believes that the
digital data generated by a pulse have their risks (e.g., illegible device presents a potential for
oximeter into a digital format that can handwriting, wrong charts, etc.), when unreasonable risk of illness or injury.
be printed. these functions are automated, users FDA is proposing that MDDS devices
• Examples of medical device data tend to rely entirely on the technology indicated for lay use or that perform
systems that would be used in the home because the technology is assumed to irreversible data compression not be
are systems that periodically collect alleviate those risks. This is especially exempt from premarket notification
data from glucose meters or blood true when software systems are requirements.
pressure devices for later review by a designed to interface with a number of
healthcare provider. unspecified medical devices. Thus, V. Risks to Health
Medical device data consist of regulatory oversight of MDDS is critical FDA believes that general controls,
numerical or other information available to ensuring that there is an adequate including the Quality System regulation
from a medical device in a form suitable expectation of performance. and the requirements for Design
for processing by computer. Medical It is FDA’s long-standing practice to Controls as per § 820.30, will provide a
device data can represent many types of not regulate those manual office reasonable assurance of safety and
information (e.g., clinical values, alarm functions that are simply automated for effectiveness for a MDDS. Risks to
conditions, error messages). MDDS are the ease of the user (e.g., office health from this device would be caused
not intended or designed to provide any automation) and that do not include by inadequate software quality.
real time, active, or online patient MDDS as described previously. For Specifically, the risk to health would be
monitoring functions. Medical device example, the report-writing functions of that incorrect medical device data is
data systems can deliver and store alarm a computer system that allow for the stored, retrieved, transferred,
data but do not have the capability to manual (typewriter like) input of data exchanged, or displayed, resulting in
display, create, or detect alarm by practitioners would not be incorrect treatment or diagnosis of the
conditions, or to actually sound an considered as a MDDS, because these patient. As explained below, FDA
alarm. In particular, a MDDS can record systems are not directly connected to a believes the risk related to inadequate
the fact that an alarm sounded, but medical device. In addition, software software quality can be mitigated
cannot by itself sound an alarm in that merely performs library functions, through application of the Quality
response to patient information. such as storing, indexing, and retrieving System Regulation.
Medical device data systems cannot information not specific to an
create alarms that are not already VI. Summary of Reasons for
individual patient, is not considered to
present from the connected medical Reclassification
be a medical device. Examples include
devices. By themselves, MDDS do not medical texts or the Physician’s Desk FDA believes that the MDDS should
provide any diagnostic or clinical Reference on CD-ROM that are indexed be reclassified into class I because
decision making functions. Medical and cross-referenced for ease of use. general controls would provide
device data systems can transmit, This proposed regulation does not reasonable assurance of safety and
exchange, store, or retrieve data in its address software that allows a doctor to effectiveness and special controls and
original format or can be used to convert enter or store a patient’s health history premarket approval are not necessary to
the medical device data from one format in a computer file. provide such assurance. FDA believes
to another so that the arrangement or that the application of the Quality
organization of the medical device data IV. Proposed Reclassification System Regulation (part 820),
is in accordance with preset Because MDDS that are subject to the particularly the design control
specifications. rulemaking are new post amendment provisions, would significantly reduce
In developing its current regulatory devices, they are deemed to be class III the risk of errors from these devices that
strategy for MDDS, FDA considered how by operation of the statute (section might cause incorrect treatment or
the risks presented by an MDDS 513(f) of the act (21 U.S.C. 360c(f)). FDA diagnosis of the patient. The design
compare to existing manual processes believes that classification in class I, controls section (§ 820.30) of the QS
for managing these data. Hospitals, with appropriate application of the regulation (§ 820.30) applies to the
clinics, and other healthcare facilities Quality System Regulation (part 820 (21 design of devices including class I
are well-aware of the shortcomings of CFR part 820)), will provide reasonable devices with software. FDA does not
manual functions and have introduced assurance of the safety and effectiveness intend to apply design controls
other manual oversight to reduce their of this device. FDA is proposing that the retroactively to currently legally
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Federal Register / Vol. 73, No. 27 / Friday, February 8, 2008 / Proposed Rules 7501
marketed MDDS devices. However, IX. Environmental Impact medical device, but would not be able
changes to existing designs or to The agency has determined under 21 to generate alarms on its own. The
currently marketed devices must be CFR 25.34(b) that this proposed MDDS device is currently classified into
made in accordance with design control reclassification action is of a type that class III, the highest level of regulatory
requirements, even if the original design does not individually or cumulatively oversight. The MDDS was initially
was not subject to these requirements, have a significant effect on the human
placed in this classification by default.
§ 820.30. This approach to MDDS manufacturers, as makers of class
implementing design controls for MDDS III devices, bear all costs associated with
is consistent with the way FDA premarket approval, including the cost
environmental impact statement is
implemented design controls after the of submitting the premarket approval
issuance of the Quality System application (PMA) and payment of user
Regulation in 1996. X. Analysis of Impact fees. The costs associated with the
FDA has examined the impacts of the submission of the PMA are substantial,
VII. Summary of Data Upon Which the
proposed rule under Executive Order potentially reaching $1,000.000.
Reclassification is Based Although we can identify several
FDA is basing this proposed rule 12866 and the Regulatory Flexibility Act
MDDS devices and device
upon the history of use of this type of (5 U.S.C. 601–612), and the Unfunded
manufacturers, we nevertheless do not
device in clinical practice as well as the Mandates Reform Act of 1995 (Public
know the size of the affected industry
substantial knowledge of FDA staff Law 104–4). Executive Order 12866 because FDA has not been enforcing
about this device type. These types of directs agencies to assess all costs and registration and listing requirements for
systems provide no new or unique benefits of available regulatory manufacturers of MDDS devices. We
clinical algorithms or clinical functions alternatives and, when regulation is welcome comment on the size and other
that have not already been reviewed and necessary, to select regulatory characteristics of the affected industry.
cleared in existing medical devices; approaches that maximize net benefits FDA is proposing to reclassify MDDS
therefore, no new pre-market review or (including potential economic, devices from class III to class I. Based
evaluation should be required. Further, environmental, public health and safety, on the history of use of this type of
FDA believes that the proper and other advantages; distributive device in clinical practice and on the
application of a Quality System impacts; and equity). The agency experience of FDA reviewers, the
approach to the design and believes that this proposed rule is not a agency concludes that in the hands of a
development of MDDS devices will significant regulatory action as defined healthcare professional, a MDDS is safe
ensure their quality. FDA believes that by the Executive Order. and effective under general controls.
this is the least burdensome approach to The Regulatory Flexibility Act The application of general controls,
the regulation of these medical devices. requires agencies to analyze regulatory including the software design controls
options that would minimize any in part 820, would be consistent with
VIII. Effective Date significant impact of a rule on small the principle of applying the least
FDA intends that this rule, if entities. Because this action is degree of regulatory control necessary to
finalized, will become effective 60 days deregulatory and imposes no new provide reasonable assurance of safety
after the date of publication of the final burdens, the agency certifies that the and effectiveness. The application of
rule. However, FDA intends to continue proposed rule will not have a significant this lowest level of regulatory oversight
to exercise enforcement discretion after economic impact on a substantial would be consistent with the treatment
publication of any final rule so that number of small entities. of other devices with similar risk
manufacturers who are already on the Section 202(a) of the Unfunded profiles. Software used to store,
market with MDDS devices may have Mandates Reform Act of 1995 requires transmit, and communicate patient
sufficient time to come into compliance that agencies prepare a written medical data, such as Laboratory
as follows: FDA expects manufacturers statement, which includes an Information Systems and Medical Image
who are already marketing a MDDS assessment of anticipated costs and Communication Systems, is typically
device before publication of a final rule benefits, before proposing ‘‘any rule that classified into class I.
and who meet the criteria for exemption includes any Federal mandate that may FDA has already recognized that the
from premarket notification to register result in the expenditure by State, local, class III requirements are not necessary
and list under part 807 within 60 days and tribal governments, in the aggregate, for ensuring the safety and effectiveness
after publication of the final rule. If a or by the private sector, of $100,000,000 of MDDS devices and has been
premarket notification is required, FDA or more (adjusted annually for inflation) exercising enforcement discretion with
expects manufacturers who are in any one year.’’ The current threshold MDDS device manufacturers. These
marketing an MDDS device without after adjustment for inflation is $127 firms have not been required to submit
FDA clearance to submit a premarket million, using the most current (2006) PMAs or meet other requirements
notification within 90 days of the Implicit Price Deflator for the Gross typically required of manufacturers of
effective date of a final rule and to Domestic Product. FDA does not expect class III devices, but the agency believes
obtain final clearance of a premarket this proposed rule to result in any 1- that all or nearly all firms in this
notification within 180 days after year expenditure that would meet or industry have in place good business
publication of a final rule. FDA expects exceed this amount. practices, including quality systems. If
manufacturers who are required to FDA were to discontinue enforcement
obtain clearance of a premarket Background
discretion, most firms would continue
notification to register and list within 30 An MDDS is a device that to comply with the class I provisions.
days after receiving a substantial electronically stores, transfers, displays,
equivalence order for their device. or reformats patient medical data. It Cost of the Proposed Regulation
Manufacturers who are not already does not provide any diagnostic or This proposed regulation is
marketing an MDDS device will be clinical decision making functions. A deregulatory. Device manufacturers
required to comply with any final rule MDDS could, for example, store alarm currently subject to class III
as of the effective date. data being generated by a connected requirements would be subject to the
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7502 Federal Register / Vol. 73, No. 27 / Friday, February 8, 2008 / Proposed Rules
less burdensome requirements for complying with these requirements MDDS devices. Considering the cost of
makers of class I devices. Of course, would be small, but would vary submitting a PMA plus the relevant user
changing the device classification may depending on the number and nature of fees, the reduction could be $1,000,000
not have an impact on the practices of the devices manufactured and the per device.
MDDS device manufacturers as long as nature of the firm’s current quality The Regulatory Flexibility Act
FDA continues its practice of system. Firms with existing quality requires agencies to analyze regulatory
enforcement discretion. For the purpose systems should be able to adapt their options that would minimize any
of this analysis, however, we assume complaint procedures to incorporate significant impact of a rule on small
that enforcement discretion would not MDR reporting with little difficulty. entities. Because reclassification of the
be permanent. The regulatory Based on our understanding of the affected devices from class III to class I
alternatives are therefore class III, II, or industry and that it has in place would relieve manufacturers of the cost
I controls, enforced by the agency. This measures to ensure quality, we believe of complying with the premarket
proposed rule would re-classify MDDS most firms would be able to adapt their approval requirements of section 515 of
devices as class I, which would reduce systems to meet FDA’s QSR and MDR the act (21 U.S.C. 360e), the agency does
the applicable regulatory requirements. regulations for no more than $20,000. not believe that this proposed rule
Manufacturers of class I devices are Again, this would not be a cost imposed would have a significant economic
required to: (1) Register and list their by this proposed rule, but the cost of an impact on a substantial number of small
MDDS devices with the agency, (2) existing burden manufacturers may not entities. FDA requests comment on this
conform to applicable medical device have incurred because FDA’s practice of issue.
current good manufacturing practice enforcement discretion with
requirements (part 820), (3) comply with manufacturers of MDDS devices. XI. Paperwork Reduction Act of 1995
Medical Device Reporting (MDR) Premarket notification. If FDA This proposed rule contains
requirements (21 CFR part 803), and (4) finalizes the classification of MDDS information collection provisions that
submit a premarket notification for the devices into class I, a manufacturer of a
are subject to review by OMB under the
device unless it is exempt. This MDDS device that is indicated for use
proposed rule proposes to exempt solely in a health care facility would not
PRA) (44 U.S.C. 3501–3520). The
MDDS devices unless they are indicated need to comply with the PMA
collections of information addressed in
for use by someone other than a requirement that applies to class III
the proposed rule have been approved
healthcare professional, perform devices or submit a premarket
by OMB in accordance with the PRA
irreversible data compression, or exceed notification. FDA is unaware of any
under the QSR (part 820, OMB Control
the limitations in § 880.9. MDDS MDDS devices that are not intended for
No. 0910–0073) and the regulations
devices indicated for use solely by a use solely by healthcare professionals,
governing premarket notification
healthcare professional, are exempt so we believe all or nearly all MDDS
from the premarket notification devices will be exempt from premarket submissions (21 CFR part 807, subpart
requirements. review. A manufacturer of a MDDS E, OMB Control No. 0910–0120).
Registration and listing. The majority device that is indicated for use by XII. Federalism
of manufacturers of MDDS devices anyone other than a healthcare
would incur a cost to register and list professional or that performs FDA has analyzed this proposed rule
their devices with the agency. We irreversible data compression would in accordance with the principles set
estimate this burden to be less than 1 need to submit a premarket notification, forth in Executive Order 13132. FDA
hour per year for manufacturers familiar but the burden of submitting a has determined that the proposed rule,
with this requirement, and up to 2 hours premarket notification is substantially if finalized, would not contain policies
of time for manufacturers not currently less than that of submitting a PMA. A that would have substantial direct
producing any FDA-regulated devices. premarket notification for a MDDS effects on the States, on the relationship
Manufacturers would also face user fees device would be far less complex than between the National Government and
of $1,708 in fiscal year (FY) 2008 to a PMA. The cost of preparing and the States, or on the distribution of
register and list their devices with the submitting such a notification would be power and responsibilities among the
agency. These fees would rise to $2,364 several thousand dollars. The user fees various levels of government.
in 2012. for a premarket notification would be Accordingly, the agency tentatively
Current Good Manufacturing $3,404 for FY 2008, increasing to $4,717 concludes that the proposed rule does
Practices (CGMP)/Quality System in 2012. In contrast, the cost of not contain policies that have
Regulation (QSR) compliance/Medical submitting a PMA can reach $1,000,000, federalism implications as defined in
Device Reporting. Based on experience plus user fees of an additional $185,000 the Executive order and, consequently,
with this and similar devices, FDA in FY 2008, increasing to $256,384 in a federalism summary impact statement
believes that most manufacturers of 2012. has not been prepared.
these devices already have quality In summary, this device XIII. Submission of Comments
systems in place as part of good reclassification would substantially
business practices. Good quality reduce an existing burden on the Interested persons may submit to the
systems would include complaint- manufacturers of MDDS devices. The Division of Dockets Management (see
handling procedures. FDA’s QSR (part regulatory burden of compliance with ADDRESSES) written or electronic
820) requirements are very flexible and the general controls provisions comments regarding this document.
FDA believes that these manufacturers applicable to the manufacturers of all Submit a single copy of electronic
will be able to conform their systems to class I devices is attributable to statutory comments or two paper copies of any
FDA requirements with little difficulty requirements that already apply but mailed comments, except that
or cost. Manufacturers are already have not been enforced. Assuming that individuals may submit one paper copy.
required to report to FDA whenever continued enforcement discretion is not Comments are to be identified with the
they learn that their device may have a viable long-term regulatory alternative, docket number found in brackets in the
caused or contributed to a death or the proposed rule would reduce the heading of this document. Received
serious injury to a patient. The cost of regulatory burden for manufacturers of comments may be seen in the Division
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Federal Register / Vol. 73, No. 27 / Friday, February 8, 2008 / Proposed Rules 7503
of Dockets Management between 9 a.m. and does not perform irreversible data 5203, Internal Revenue Service, PO Box
and 4 p.m., Monday through Friday. compression, it is exempt from the 7604, Ben Franklin Station, Washington,
Please note that on January 15, 2008, premarket notification procedures in DC 20044. Submissions may be hand
the FDA Web site transitioned to the subpart E of part 807, subject to the delivered Monday through Friday
Federal Dockets Management System limitations in § 880.9. When the device between the hours of 8 a.m. and 4 p.m.
(FDMS). FDMS is a Government-wide, is indicated to be prescribed by a to: CC:PA:LPD:PR (REG–153589–06),
electronic docket management system. healthcare professional for use by a lay Courier’s Desk, Internal Revenue
Electronic submissions will be accepted user, or performs irreversible data Service, 1111 Constitution Avenue,
by FDA through FDMS only. compression, or for over-the-counter use NW., Washington, DC, or sent
by a lay user, the device requires the electronically via the Federal
submission and clearance of a eRulemaking Portal at
Medical devices. premarket notification. www.regulations.gov (IRS REG–
Therefore, under the Federal Food, Dated: January 25, 2008. 153589–06).
Drug, and Cosmetic Act and under FOR FURTHER INFORMATION CONTACT:
authority delegated to the Commissioner Concerning the proposed regulation,
of Food and Drugs, FDA proposes to Director, Center for Devices and Radiological
Health. Jamie Kim, (202) 622–4950; concerning
amend 21 CFR part 880 as follows: submission of comments or requesting a
[FR Doc. E8–2325 Filed 2–7–08; 8:45 am]
hearing, Richard.A.Hurst@irscounsel.
PART 880—GENERAL HOSPITAL AND BILLING CODE 4160–01–S
treas.gov, (202) 622–7180 (not toll-free
1. The authority citation for 21 CFR SUPPLEMENTARY INFORMATION:
part 880 continues to read as follows:
Background and Explanation of
Authority: 21 U.S.C. 351, 360, 360c, 360e, Internal Revenue Service
360j, 371. Provisions
2. Part 880 is amended in subpart G 26 CFR Part 1 Temporary regulation in the Rules
by adding § 880.6310 to read as follows: and Regulations section of this issue of
[REG–153589–06]
the Federal Register amends the Income
§ 880.6310 Medical Device Data System. Tax Regulations (26 CFR part 1) relating
RIN 1545–BG34
(a) Identification. (1) A medical to section 1221(b)(3) of the Internal
device data system (MDDS) is a device Time and Manner for Electing Capital Revenue Code (Code). The temporary
intended to provide one or more of the Asset Treatment for Certain Self- regulation provides rules regarding the
following uses: Created Musical Works time and manner for making an election
(i) The electronic transfer or exchange under section 1221(b)(3) to treat the sale
of medical device data from a medical AGENCY: Internal Revenue Service (IRS),
Treasury. or exchange of certain musical
device, without altering the function or compositions or copyrights in musical
parameters of any connected devices. ACTION: Notice of proposed rulemaking works as the sale or exchange of a
(ii) The electronic storage and by cross-reference to temporary capital asset. The text of the temporary
retrieval of medical device data from a regulation. regulation also serves as the text of this
medical device, without altering the proposed regulation. The preamble to
SUMMARY: In the Rules and Regulations
function or parameters of connected the temporary regulation explains the
devices. section of this issue of the Federal
Register, the IRS is issuing a temporary amendments.
(iii) The electronic display of medical
device data from a medical device, regulation that provides the time and Special Analyses
without altering the function or manner for making an election to treat
parameters of connected devices. the sale or exchange of musical
(iv) The electronic conversion of compositions or copyrights in musical
medical device data from one format to works created by the taxpayer (or
another format in accordance with a received by the taxpayer from the
preset specification. works’ creator in a transferred basis
also has been determined that section
(2) Medical device data consists of transaction) as the sale or exchange of
numerical or other information available a capital asset. The temporary regulation
from a medical device in a form suitable reflects changes to the law made by the
to this regulation, and because the
for processing by computer. Medical Tax Increase Prevention and
regulation does not impose a collection
device data can represent any type of Reconciliation Act of 2005 and the Tax
of information on small entities, the
information or knowledge, e.g., clinical Relief and Health Care Act of 2006. The
Regulatory Flexibility Act (5 U.S.C.
values, alarm conditions, error temporary regulation affects taxpayers
messages. This identification does not making the election under section
section 7805(f) of the Internal Revenue
include a device that creates diagnostic, 1221(b)(3) of the Internal Revenue Code
Code, this regulation has been
decision support, or alarm functions. It (Code) to treat gain or loss from such a
also does not include the report-writing sale or exchange as capital gain or loss.
functions of a data system that allows The text of the temporary regulation
for the manual input of data by also serves as the text of this proposed
practitioners. This identification does regulation.
not include devices with any real time, DATES: Written or electronic comments Comments and Requests for a Public
active, or online patient monitoring. and requests for a public hearing must Hearing
(b) Classification. Class I (general be received by May 8, 2008. Before this proposed regulation is
controls). When the device is indicated ADDRESSES: Send submissions to: adopted as a final regulation,
for use only by a healthcare professional CC:PA:LPD:PR (REG–153589–06), room consideration will be given to any
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