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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. 

TABLE 1.—PROHIBITED PARTS

Part Part No. 

Elevator trim tab actuator .. 120–19685–001 

120–19685–003 

120–19685–007 

120–38650–001 

120–39205–001 

5299 

5299–1 

Control cable ...................... 120–27729–095 

120–27729–097 

120–31370–095 

120–31370–097 

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 

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. 

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] 

BILLING CODE 4910–13–P 

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: 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 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 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 


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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: 

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 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 

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 § 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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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. 

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 § 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 

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 


ebenthall on PRODPC61 with PROPOSALS
Federal Register / Vol. 73, No. 27 / Friday, February 8, 2008 / Proposed Rules 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 § 880.6310 to read as follows: 

§ 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 § 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 

DEPARTMENT OF THE TREASURY 

Internal Revenue Service 

26 CFR Part 1 

[REG–153589–06] 

RIN 1545–BG34 

Time and Manner for Electing Capital 

Asset Treatment for Certain SelfCreated Musical Works 

AGENCY: Internal Revenue Service (IRS), 

Treasury. 

ACTION: Notice of proposed rulemaking 

by cross-reference to temporary 

regulation. 

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 

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). 

SUPPLEMENTARY INFORMATION: 

Background and Explanation of 

Provisions 

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. 

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 


ebenthall on PRODPC61 with PROPOSALS