Document ID: FDA-2008-N-0106-0001
Agency: fda
Document Type: Proposed Rule
Title: Devices: General Hospital and Personal Use Devices; Reclassification of Medical Device Data System
Posted Date: 2008-02-08T05:00Z

[Federal Register: February 8, 2008 (Volume 73, Number 27)]
[Proposed Rules]               
[Page 7498-7503]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08fe08-20]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 880

[Docket No. 2007N-0484]

 
Devices: General Hospital and Personal Use Devices; 
Reclassification of Medical Device Data System

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to 
reclassify, on its own initiative, the Medical Device Data System 
(MDDS) from class III (premarket approval) to class I (general 
controls). This action does not include medical device data systems 
with new diagnostic or alarm functions. FDA is also proposing that the 
MDDS be exempt from the premarket notification requirements when it is 
indicated for use only by a healthcare professional and does not 
perform irreversible data compression.

DATES: Submit written or electronic comments on the proposed rule by 
May 8, 2008. Submit comments regarding information collection by March 
10, 2008, to the Office of Management and Budget (OMB) (see ADDRESSES). 
FDA proposes that any final regulation based on this proposal become 
effective 60 days after its date of publication in the Federal 
Register. See section VIII of the SUPPLEMENTARY INFORMATION section of 
the preamble for further information about the effective date.

ADDRESSES: You may submit comments, identified by Docket No. 2007N-
0484, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 

Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the followings ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier (For paper, disk, or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of comments, FDA is no longer 
accepting comments submitted to the agency by e-mail. FDA encourages 
you to continue to submit electronic comments by using the Federal 
eRulemaking Portal or the agency Web site, as described previously, in 
the ADDRESSES portion of this document under Electronic Submissions.
    Instructions: All submissions received must include the agency name 
and Docket No.(s) and Regulatory Information Number (RIN) (if a RIN 
number has been assigned) for this rulemaking. All comments received 
may be posted without change to http://www.regulations.gov, including 

any personal information provided. For additional information on 
submitting comments, see the ``Comments'' heading of the SUPPLEMENTARY 
INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 

docket number(s), found in brackets in the heading of this document, 
into the

[[Page 7499]]

``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Information Collection Provisions: Submit written comments on the 
information collection provisions to the Office of Information and 
Regulatory Affairs, OMB. To ensure that comments on the information 
collection are received, OMB recommends that written comments be faxed 
to the Office of Information and Regulatory Affairs, OMB, Attn: FDA 
Desk Officer, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Anthony D. Watson, Center for Devices 
and Radiological Health (HFZ-480), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 240-276-3700.

SUPPLEMENTARY INFORMATION:

I. Background (Regulatory Authorities)

    The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301 
et seq.), as amended by the Medical Device Amendments of 1976 (the 1976 
amendments) (Public Law 94-295), the Safe Medical Devices Act of 1990 
(SMDA) (Public Law 101-629), and the Food and Drug Administration 
Modernization Act of 1997 (FDAMA) (Public Law 105-115), established a 
comprehensive system for the regulation of medical devices intended for 
human use. Section 513(a)(1) of the act (21 U.S.C. 360c) established 
three categories (classes) of devices, depending on the regulatory 
controls needed to provide reasonable assurance of their safety and 
effectiveness. The three categories of devices are:
     Class I (general controls),
     Class II (special controls), and
     Class III (premarket approval).
    FDA refers to devices that were in commercial distribution before 
May 28, 1976 (the date of enactment of the 1976 amendments), as 
``preamendment devices.'' FDA classifies these devices after it:
    1. Receives a recommendation from a device classification panel (an 
FDA advisory committee);
    2. Publishes the panel's recommendation for comment, along with a 
proposed regulation classifying the device; and
    3. Publishes a final regulation classifying the device.
    FDA has classified most preamendments devices under these 
procedures.
    The agency determines whether new devices are substantially 
equivalent to predicate devices by means of premarket notification 
procedures in section 510(k) of the act (21 U.S.C. 360(k)) and part 807 
of the regulations (21 CFR part 807).
    Reclassification of postamendment devices is governed by section 
513(f)(3) of the act, formerly section 513(f)(2) of the act. This 
section provides that FDA may initiate the reclassification of a device 
classified into class III under section 513(f)(1) of the act, or the 
manufacturer or importer of a device may petition the Secretary of 
Health and Human Services for the issuance of an order classifying the 
device in class I or class II. FDA's regulations in 21 CFR 860.134 set 
forth the procedures for the filing and review of a petition for 
reclassification of such class III devices. In order to change the 
classification of the device, it is necessary that the proposed new 
classification have sufficient regulatory controls to provide 
reasonable assurance of the safety and effectiveness of the device for 
its intended use.
    FDAMA added section 510(l) to the act. Section 510(l) of the act 
provides that a class I device is exempt from the premarket 
notification requirements under section 510(k) of the act, unless the 
device is intended for a use which is of substantial importance in 
preventing impairment of human health or it presents a potential 
unreasonable risk of illness or injury. FDA refers to the criteria that 
designate a class I device as not exempt from premarket notification as 
``reserved criteria.'' An exemption permits manufacturers to introduce 
into commercial distribution generic types of devices without first 
submitting a premarket notification to FDA.

II. Regulatory History of the Device

    Computer-based and software-based products are subject to 
regulation as devices when they meet the definition of a device 
contained in section 201(h) of the act (21 U.S.C. 321(h)). In 1989, FDA 
prepared a general policy statement on how it planned to determine 
whether a computer-based product and/or software based product is a 
device and, if so, how FDA intended to regulate it. This document 
became known as the ``Draft Software Policy.'' The scope and intention 
of the 1989 policy were based on the existing state of computer and 
software technology at that time. That policy included the principle 
that the level of FDA oversight of software should depend primarily on 
the risk to the patient should the software fail to perform in 
accordance with its specifications.
    Since 1989, the use of computer-based products and software-based 
products as medical devices has grown exponentially. In addition, 
device interconnectivity and complexity have grown in ways that could 
not have been predicted in 1989. This growth and expansion have created 
new considerations for elements of risk that did not previously exist. 
FDA realized that the Draft Software Policy was not adequate to address 
all of the issues related to the regulation of computer-based and 
software-based medical devices. Based on this history and the 
complexity and diversity of computer software, FDA decided it would be 
impractical to prepare one ``software'' or ``computer'' policy that 
would be able to address all the issues related to the regulation of 
computer- and software-based medical devices. Nonetheless, the 
principle that the level of FDA oversight of software should depend 
primarily on the risk to the patient should the software fail to 
perform in accordance with its specifications remains important. Many 
software classifications reflect this principle, including:
     FDA has classified software used in computer aided 
detection of cancerous lesions in the breast in class III;
     FDA has classified software used in computer tomography 
(CT) and X-ray systems to provide images to assist in clinical 
decisionmaking in class II; and
     FDA has classified laboratory information systems in class 
I.
    This principle also informs this proposed reclassification, in 
which FDA is focusing on a category of post amendment computer- and 
software-based devices that present a low risk and should not be 
subject to premarket review that have not been classified elsewhere. An 
examination of modern medical device networks and computer 
infrastructure helped FDA to identify a category of computer based and 
software products that meet the definition of a device, which the FDA 
would consider to pose minimal risks, and that should not be Class III 
and should not require premarket submission. This medical device has 
been named a ``Medical Device Data System.''

III. Device Description

    A medical device data system (MDDS) is a device intended to provide 
one or more of the following uses:
     The electronic transfer or exchange of medical device data 
from a medical device, without altering the function or parameters of 
any connected devices. For example, this would include software that 
interrogates a ventilator every 15 minutes and transfers information 
about patient CO\2\ levels to a central patient data repository;

[[Page 7500]]

     The electronic storage and retrieval of medical device 
data, without altering the function or parameters of connected devices. 
For example, this would include software that stores historical blood 
pressure information for later review by a healthcare provider;
     The electronic display of medical device data, without 
altering the function or parameters of connected devices. For example, 
this would include software that displays the previously stored 
electrocardiogram for a particular patient;
     The electronic conversion of medical device data from one 
format to another format in accordance with a preset specification. For 
example, this would include software that converts digital data 
generated by a pulse oximeter into a digital format that can be 
printed.
     Examples of medical device data systems that would be used 
in the home are systems that periodically collect data from glucose 
meters or blood pressure devices for later review by a healthcare 
provider.
    Medical device data consist of numerical or other information 
available from a medical device in a form suitable for processing by 
computer. Medical device data can represent many types of information 
(e.g., clinical values, alarm conditions, error messages). MDDS are not 
intended or designed to provide any real time, active, or online 
patient monitoring functions. Medical device data systems can deliver 
and store alarm data but do not have the capability to display, create, 
or detect alarm conditions, or to actually sound an alarm. In 
particular, a MDDS can record the fact that an alarm sounded, but 
cannot by itself sound an alarm in response to patient information. 
Medical device data systems cannot create alarms that are not already 
present from the connected medical devices. By themselves, MDDS do not 
provide any diagnostic or clinical decision making functions. Medical 
device data systems can transmit, exchange, store, or retrieve data in 
its original format or can be used to convert the medical device data 
from one format to another so that the arrangement or organization of 
the medical device data is in accordance with preset specifications.
    In developing its current regulatory strategy for MDDS, FDA 
considered how the risks presented by an MDDS compare to existing 
manual processes for managing these data. Hospitals, clinics, and other 
healthcare facilities are well-aware of the shortcomings of manual 
functions and have introduced other manual oversight to reduce their 
effects, such as audits of records and multiple-person checks of 
paperwork prior to treatments. These facilities have also introduced 
electronic systems to help reduce the human element in these errors. 
However, when data are being stored, retrieved, transferred, exchanged, 
or displayed electronically, an additional element of risk is 
introduced. This element of risk would not be present for a manual 
transfer of files or information because the information is readily 
apparent to the healthcare provider.
    When manual data is converted to electronic form, data can be 
altered in such a way as to not be transparent to the user and pose a 
risk to the patient. In effect, even though manual functions have their 
risks (e.g., illegible handwriting, wrong charts, etc.), when these 
functions are automated, users tend to rely entirely on the technology 
because the technology is assumed to alleviate those risks. This is 
especially true when software systems are designed to interface with a 
number of unspecified medical devices. Thus, regulatory oversight of 
MDDS is critical to ensuring that there is an adequate expectation of 
performance.
    It is FDA's long-standing practice to not regulate those manual 
office functions that are simply automated for the ease of the user 
(e.g., office automation) and that do not include MDDS as described 
previously. For example, the report-writing functions of a computer 
system that allow for the manual (typewriter like) input of data by 
practitioners would not be considered as a MDDS, because these systems 
are not directly connected to a medical device. In addition, software 
that merely performs library functions, such as storing, indexing, and 
retrieving information not specific to an individual patient, is not 
considered to be a medical device. Examples include medical texts or 
the Physician's Desk Reference on CD-ROM that are indexed and cross-
referenced for ease of use. This proposed regulation does not address 
software that allows a doctor to enter or store a patient's health 
history in a computer file.

IV. Proposed Reclassification

    Because MDDS that are subject to the rulemaking are new post 
amendment devices, they are deemed to be class III by operation of the 
statute (section 513(f) of the act (21 U.S.C. 360c(f)). FDA believes 
that classification in class I, with appropriate application of the 
Quality System Regulation (part 820 (21 CFR part 820)), will provide 
reasonable assurance of the safety and effectiveness of this device. 
FDA is proposing that the Medical Device Data System be reclassified 
from class III to class I. In addition, FDA is proposing that when the 
device is indicated for use only by a healthcare professional and does 
not perform irreversible data compression, in accordance with section 
510(l) of the act (21 U.S.C. 360(l)), it would be exempt from the 
premarket notification procedures in subpart E of part 807, subject to 
the limitations in Sec.  880.9 (21 CFR 880.9). For purposes of this 
regulation, ``healthcare professional'' is any practitioner licensed by 
the law of the State in which he or she practices to use or order the 
use of the device. When the device is indicated for use by a lay user, 
or performs irreversible data compression, FDA believes that the device 
presents a potential for unreasonable risk of illness or injury. FDA is 
proposing that MDDS devices indicated for lay use or that perform 
irreversible data compression not be exempt from premarket notification 
requirements.

V. Risks to Health

    FDA believes that general controls, including the Quality System 
regulation and the requirements for Design Controls as per Sec.  
820.30, will provide a reasonable assurance of safety and effectiveness 
for a MDDS. Risks to health from this device would be caused by 
inadequate software quality. Specifically, the risk to health would be 
that incorrect medical device data is stored, retrieved, transferred, 
exchanged, or displayed, resulting in incorrect treatment or diagnosis 
of the patient. As explained below, FDA believes the risk related to 
inadequate software quality can be mitigated through application of the 
Quality System Regulation.

VI. Summary of Reasons for Reclassification

    FDA believes that the MDDS should be reclassified into class I 
because general controls would provide reasonable assurance of safety 
and effectiveness and special controls and premarket approval are not 
necessary to provide such assurance. FDA believes that the application 
of the Quality System Regulation (part 820), particularly the design 
control provisions, would significantly reduce the risk of errors from 
these devices that might cause incorrect treatment or diagnosis of the 
patient. The design controls section (Sec.  820.30) of the QS 
regulation (Sec.  820.30) applies to the design of devices including 
class I devices with software. FDA does not intend to apply design 
controls retroactively to currently legally

[[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

[[Page 7502]]

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

[[Page 7503]]

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