proposed fda regulation of medical device data systems

8/9/2019 Proposed FDA Regulation of Medical Device Data Systems

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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.

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 ferryflight 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 theeffective date of this AD, install two placardson the glareshield, advising the flight crew tocheck the pitch trim before initial descent, inaccordance with Part II of theAccomplishment Instructions of EMBRAERService Bulletin 120250262, Change 02,dated October 30, 2003.

Elevator Trim System Modification

(d) Within 36 months after the effectivedate of this AD, modify the elevator trimsystem, in accordance with theAccomplishment Instructions of EMBRAERService Bulletin 120270095 and 120270096, both dated February 16, 2007.Accomplishment of the modificationterminates the requirements of paragraphs(a), (b), and (c) of this AD, and thecorresponding AFM revisions and placardsmay be removed.

Parts Installation

(e) As of 36 months after the effective dateof this AD, no person may install, on anyairplane, an elevator trim tab actuator orcontrol cable having a part number identifiedin Table 1 of this AD.

TABLE 1.PROHIBITED PARTS

Part Part No.

Elevator trim tab actuator .. 1201968500112019685003120196850071203865000112039205001529952991

Control cable ...................... 12027729095120277290971203137009512031370097

Alternative Methods of Compliance

(f)(1) The Manager, International Branch,ANM116, Transport Airplane Directorate,FAA, has the authority to approve AMOCsfor this AD, if requested in accordance withthe procedures found in 14 CFR 39.19.

(2) To request a different method ofcompliance or a different compliance timefor this AD, follow the procedures in 14 CFR39.19. Before using any approved AMOC onany 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 localFSDO.

Note 1: The subject of this AD is addressedin Brazilian airworthiness directive 20010601R4, effective August 23, 2007.

Issued in Renton, Washington, on February1, 2008.

Ali Bahrami,

Manager, Transport Airplane Directorate,

Aircraft Certification Service.[FR Doc. E82356 Filed 2708; 8:45 am]

BILLING CODE 491013P

DEPARTMENT OF HEALTH ANDHUMAN SERVICES

Food and Drug Administration

21 CFR Part 880

[Docket No. 2007N0484]

Devices: General Hospital andPersonal Use Devices; Reclassification

of Medical Device Data System

AGENCY: Food and Drug Administration,HHS.

ACTION: Proposed rule.

SUMMARY: The Food and DrugAdministration (FDA) is proposing toreclassify, on its own initiative, theMedical Device Data System (MDDS)from class III (premarket approval) toclass I (general controls). This actiondoes not include medical device datasystems with new diagnostic or alarmfunctions. FDA is also proposing thatthe MDDS be exempt from thepremarket notification requirementswhen it is indicated for use only by ahealthcare professional and does notperform irreversible data compression.

DATES: Submit written or electroniccomments on the proposed rule by May8, 2008. Submit comments regardinginformation collection by March 10,2008, to the Office of Management andBudget (OMB) (see ADDRESSES). FDAproposes that any final regulation basedon this proposal become effective 60days after its date of publication in the

Federal Register. See section VIII of theSUPPLEMENTARY INFORMATION section ofthe preamble for further informationabout the effective date.ADDRESSES: You may submit comments,identified by Docket No. 2007N0484,

by any of the following methods:

Electronic Submissions

Submit electronic comments in thefollowing way: Federal eRulemaking Portal: http://

www.regulations.gov. Follow theinstructions for submitting comments.

Written Submissions

Submit written submissions in thefollowings ways:

FAX: 3018276870. Mail/Hand delivery/Courier (For

paper, disk, or CD-ROM submissions):Division of Dockets Management (HFA305), Food and Drug Administration,5630 Fishers Lane, rm. 1061, Rockville,MD 20852.

To ensure more timely processing ofcomments, FDA is no longer acceptingcomments submitted to the agency by e-mail. FDA encourages you to continueto submit electronic comments by usingthe Federal eRulemaking Portal or theagency Web site, as describedpreviously, in the ADDRESSES portion ofthis document under ElectronicSubmissions.

Instructions: All submissions receivedmust include the agency name andDocket No.(s) and RegulatoryInformation Number (RIN) (if a RINnumber has been assigned) for this

rulemaking. All comments received maybe posted without change to http://www.regulations.gov, including anypersonal information provided. Foradditional information on submittingcomments, see the Comments headingof the SUPPLEMENTARY INFORMATIONsection of this document.

Docket: For access to the docket toread background documents orcomments received, go to http://www.regulations.govand insert thedocket number(s), found in brackets inthe heading of this document, into the

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7499Federal Register / Vol. 73, No. 27/ Friday, February 8, 2008/ Proposed Rules

Search box and follow the promptsand/or go to the Division of DocketsManagement, 5630 Fishers Lane, rm.1061, Rockville, MD 20852.

Information Collection Provisions:Submit written comments on theinformation collection provisions to theOffice of Information and RegulatoryAffairs, OMB. To ensure that comments

on the information collection arereceived, OMB recommends that writtencomments be faxed to the Office ofInformation and Regulatory Affairs,OMB, Attn: FDA Desk Officer, FAX:2023956974.

FOR FURTHER INFORMATION CONTACT:Anthony D. Watson, Center for Devicesand Radiological Health (HFZ480),Food and Drug Administration, 9200Corporate Blvd., Rockville, MD 20850,2402763700.

SUPPLEMENTARY INFORMATION:

I. Background (Regulatory Authorities)

The Federal Food, Drug, and CosmeticAct (the act) (21 U.S.C. 301 et seq.), asamended by the Medical DeviceAmendments of 1976 (the 1976amendments) (Public Law 94295), theSafe Medical Devices Act of 1990(SMDA) (Public Law 101629), and theFood and Drug AdministrationModernization Act of 1997 (FDAMA)(Public Law 105115), established acomprehensive system for the regulationof medical devices intended for humanuse. Section 513(a)(1) of the act (21U.S.C. 360c) established three categories(classes) of devices, depending on the

regulatory controls needed to providereasonable assurance of their safety andeffectiveness. The three categories ofdevices 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 1976amendments), as preamendmentdevices. FDA classifies these devicesafter it:

1. Receives a recommendation from adevice classification panel (an FDA

advisory committee);2. Publishes the panelsrecommendation for comment, alongwith a proposed regulation classifyingthe device; and

3. Publishes a final regulationclassifying the device.

FDA has classified mostpreamendments devices under theseprocedures.

The agency determines whether newdevices are substantially equivalent topredicate devices by means ofpremarket 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 postamendmentdevices is governed by section 513(f)(3)of the act, formerly section 513(f)(2) ofthe act. This section provides that FDAmay initiate the reclassification of adevice classified into class III under

section 513(f)(1) of the act, or themanufacturer or importer of a devicemay petition the Secretary of Health andHuman Services for the issuance of anorder classifying the device in class I orclass II. FDAs regulations in 21 CFR860.134 set forth the procedures for thefiling and review of a petition forreclassification of such class III devices.In order to change the classification ofthe device, it is necessary that theproposed new classification havesufficient regulatory controls to providereasonable assurance of the safety andeffectiveness of the device for its

intended use.FDAMA added section 510(l) to theact. Section 510(l) of the act providesthat a class I device is exempt from thepremarket notification requirementsunder section 510(k) of the act, unlessthe device is intended for a use whichis of substantial importance inpreventing impairment of human healthor it presents a potential unreasonablerisk of illness or injury. FDA refers tothe criteria that designate a class Idevice as not exempt from premarketnotification as reserved criteria. Anexemption permits manufacturers tointroduce into commercial distribution

generic types of devices without firstsubmitting a premarket notification toFDA.

II. Regulatory History of the Device

Computer-based and software-basedproducts are subject to regulation asdevices when they meet the definitionof a device contained in section 201(h)of the act (21 U.S.C. 321(h)). In 1989,FDA prepared a general policystatement on how it planned todetermine whether a computer-basedproduct and/or software based productis a device and, if so, how FDA intended

to regulate it. This document becameknown as the Draft Software Policy.The scope and intention of the 1989policy were based on the existing stateof computer and software technology atthat time. That policy included theprinciple that the level of FDA oversightof software should depend primarily onthe risk to the patient should thesoftware fail to perform in accordancewith its specifications.

Since 1989, the use of computer-basedproducts and software-based productsas medical devices has grown

exponentially. In addition, deviceinterconnectivity and complexity havegrown in ways that could not have beenpredicted in 1989. This growth andexpansion have created newconsiderations for elements of risk thatdid not previously exist. FDA realizedthat the Draft Software Policy was notadequate to address all of the issues

related to the regulation of computer-based and software-based medicaldevices. Based on this history and thecomplexity and diversity of computersoftware, FDA decided it would beimpractical to prepare one software orcomputer policy that would be able toaddress all the issues related to theregulation of computer- and software-

based medical devices. Nonetheless, theprinciple that the level of FDA oversightof software should depend primarily onthe risk to the patient should thesoftware fail to perform in accordancewith its specifications remains

important. Many software classificationsreflect this principle, including: FDA has classified software used in

computer aided detection of cancerouslesions in the breast in class III;

FDA has classified software used incomputer tomography (CT) and X-raysystems to provide images to assist inclinical decisionmaking in class II; and

FDA has classified laboratoryinformation systems in class I.

This principle also informs thisproposed reclassification, in which FDAis focusing on a category of postamendment computer- and software-

based devices that present a low riskand should not be subject to premarketreview that have not been classifiedelsewhere. An examination of modernmedical device networks and computerinfrastructure helped FDA to identify acategory of computer based andsoftware products that meet thedefinition of a device, which the FDAwould consider to pose minimal risks,and that should not be Class III andshould not require premarketsubmission. This medical device has

been named a Medical Device DataSystem.

III. Device DescriptionA medical device data system (MDDS)

is a device intended to provide one ormore of the following uses:

The electronic transfer or exchangeof medical device data from a medicaldevice, without altering the function orparameters of any connected devices.For example, this would includesoftware that interrogates a ventilatorevery 15 minutes and transfersinformation about patient CO2 levels toa central patient data repository;



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The electronic storage and retrievalof medical device data, without alteringthe function or parameters of connecteddevices. For example, this wouldinclude software that stores historical

blood pressure information for laterreview by a healthcare provider;

The electronic display of medicaldevice data, without altering the

function or parameters of connecteddevices. For example, this wouldinclude software that displays thepreviously stored electrocardiogram fora particular patient;

The electronic conversion ofmedical device data from one format toanother format in accordance with apreset specification. For example, thiswould include software that convertsdigital data generated by a pulseoximeter into a digital format that can

be printed. Examples of medical device data

systems that would be used in the homeare systems that periodically collectdata from glucose meters or bloodpressure devices for later review by ahealthcare provider.

Medical device data consist ofnumerical or other information availablefrom a medical device in a form suitablefor processing by computer. Medicaldevice data can represent many types ofinformation (e.g., clinical values, alarmconditions, error messages). MDDS arenot intended or designed to provide anyreal time, active, or online patientmonitoring functions. Medical devicedata systems can deliver and store alarmdata but do not have the capability to

display, create, or detect alarmconditions, or to actually sound analarm. In particular, a MDDS can recordthe fact that an alarm sounded, butcannot by itself sound an alarm inresponse to patient information.Medical device data systems cannotcreate alarms that are not alreadypresent from the connected medicaldevices. By themselves, MDDS do notprovide any diagnostic or clinicaldecision making functions. Medicaldevice data systems can transmit,exchange, store, or retrieve data in itsoriginal format or can be used to convert

the medical device data from one formatto another so that the arrangement ororganization of the medical device datais in accordance with presetspecifications.

In developing its current regulatorystrategy for MDDS, FDA considered howthe risks presented by an MDDScompare to existing manual processesfor managing these data. Hospitals,clinics, and other healthcare facilitiesare well-aware of the shortcomings ofmanual functions and have introducedother manual oversight to reduce their

effects, such as audits of records andmultiple-person checks of paperworkprior to treatments. These facilities havealso introduced electronic systems tohelp reduce the human element in theseerrors. However, when data are beingstored, retrieved, transferred,exchanged, or displayed electronically,an additional element of risk is

introduced. This element of risk wouldnot be present for a manual transfer offiles or information because theinformation is readily apparent to thehealthcare provider.

When manual data is converted toelectronic form, data can be altered insuch a way as to not be transparent tothe user and pose a risk to the patient.In effect, even though manual functionshave their risks (e.g., illegiblehandwriting, wrong charts, etc.), whenthese functions are automated, userstend to rely entirely on the technology

because the technology is assumed to

alleviate those risks. This is especiallytrue when software systems aredesigned to interface with a number ofunspecified medical devices. Thus,regulatory oversight of MDDS is criticalto ensuring that there is an adequateexpectation of performance.

It is FDAs long-standing practice tonot regulate those manual officefunctions that are simply automated forthe ease of the user (e.g., officeautomation) and that do not includeMDDS as described previously. Forexample, the report-writing functions ofa computer system that allow for themanual (typewriter like) input of data

by practitioners would not beconsidered as a MDDS, because thesesystems are not directly connected to amedical device. In addition, softwarethat merely performs library functions,such as storing, indexing, and retrievinginformation not specific to anindividual patient, is not considered to

be a medical device. Examples includemedical texts or the Physicians DeskReference on CD-ROM that are indexedand cross-referenced for ease of use.This proposed regulation does notaddress software that allows a doctor toenter or store a patients health history

in a computer file.IV. Proposed Reclassification

Because MDDS that are subject to therulemaking are new post amendmentdevices, they are deemed to be class III

by operation of the statute (section513(f) of the act (21 U.S.C. 360c(f)). FDA

believes that classification in class I,with appropriate application of theQuality System Regulation (part 820 (21CFR part 820)), will provide reasonableassurance of the safety and effectivenessof this device. FDA is proposing that the

Medical Device Data System bereclassified from class III to class I. Inaddition, FDA is proposing that whenthe device is indicated for use only bya healthcare professional and does notperform irreversible data compression,in accordance with section 510(l) of theact (21 U.S.C. 360(l)), it would beexempt from the premarket notification

procedures in subpart E of part 807,subject to the limitations in 880.9 (21CFR 880.9). For purposes of thisregulation, healthcare professional isany practitioner licensed by the law ofthe State in which he or she practicesto use or order the use of the device.When the device is indicated for use bya lay user, or performs irreversible datacompression, FDA believes that thedevice presents a potential forunreasonable risk of illness or injury.FDA is proposing that MDDS devicesindicated for lay use or that performirreversible data compression not be

exempt from premarket notificationrequirements.

V. Risks to Health

FDA believes that general controls,including the Quality System regulationand the requirements for DesignControls as per 820.30, will provide areasonable assurance of safety andeffectiveness for a MDDS. Risks tohealth from this device would be caused

by inadequate software quality.Specifically, the risk to health would bethat incorrect medical device data isstored, retrieved, transferred,exchanged, or displayed, resulting in

incorrect treatment or diagnosis of thepatient. As explained below, FDA

believes the risk related to inadequatesoftware quality can be mitigatedthrough application of the QualitySystem Regulation.

VI. Summary of Reasons forReclassification

FDA believes that the MDDS shouldbe reclassified into class I becausegeneral controls would providereasonable assurance of safety andeffectiveness and special controls andpremarket approval are not necessary to

provide such assurance. FDA believesthat the application of the QualitySystem Regulation (part 820),particularly the design controlprovisions, would significantly reducethe risk of errors from these devices thatmight cause incorrect treatment ordiagnosis of the patient. The designcontrols section (820.30) of the QSregulation (820.30) applies to thedesign of devices including class Idevices with software. FDA does notintend to apply design controlsretroactively to currently legally



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marketed MDDS devices. However,changes to existing designs or tocurrently marketed devices must bemade in accordance with design controlrequirements, even if the original designwas not subject to these requirements,820.30. This approach toimplementing design controls for MDDSis consistent with the way FDA

implemented design controls after theissuance of the Quality SystemRegulation in 1996.

VII. Summary of Data Upon Which theReclassification is Based

FDA is basing this proposed ruleupon the history of use of this type ofdevice in clinical practice as well as thesubstantial knowledge of FDA staffabout this device type. These types ofsystems provide no new or uniqueclinical algorithms or clinical functionsthat have not already been reviewed andcleared in existing medical devices;therefore, no new pre-market review orevaluation should be required. Further,FDA believes that the properapplication of a Quality Systemapproach to the design anddevelopment of MDDS devices willensure their quality. FDA believes thatthis is the least burdensome approach tothe regulation of these medical devices.

VIII. Effective Date

FDA intends that this rule, iffinalized, will become effective 60 daysafter the date of publication of the finalrule. However, FDA intends to continueto exercise enforcement discretion after

publication of any final rule so thatmanufacturers who are already on themarket with MDDS devices may havesufficient time to come into complianceas follows: FDA expects manufacturerswho are already marketing a MDDSdevice before publication of a final ruleand who meet the criteria for exemptionfrom premarket notification to registerand list under part 807 within 60 daysafter publication of the final rule. If apremarket notification is required, FDAexpects manufacturers who aremarketing an MDDS device withoutFDA clearance to submit a premarket

notification within 90 days of theeffective date of a final rule and toobtain final clearance of a premarketnotification within 180 days afterpublication of a final rule. FDA expectsmanufacturers who are required toobtain clearance of a premarketnotification to register and list within 30days after receiving a substantialequivalence order for their device.Manufacturers who are not alreadymarketing an MDDS device will berequired to comply with any final ruleas of the effective date.

IX. Environmental Impact

The agency has determined under 21CFR 25.34(b) that this proposedreclassification action is of a type thatdoes not individually or cumulativelyhave a significant effect on the humanenvironment. Therefore, neither anenvironmental assessment nor an

environmental impact statement isrequired.

X. Analysis of Impact

FDA has examined the impacts of theproposed rule under Executive Order12866 and the Regulatory Flexibility Act(5 U.S.C. 601612), and the UnfundedMandates Reform Act of 1995 (PublicLaw 1044). Executive Order 12866directs agencies to assess all costs and

benefits of available regulatoryalternatives and, when regulation isnecessary, to select regulatoryapproaches that maximize net benefits(including potential economic,

environmental, public health and safety,and other advantages; distributiveimpacts; and equity). The agency

believes that this proposed rule is not asignificant regulatory action as defined

by the Executive Order.The Regulatory Flexibility Act

requires agencies to analyze regulatoryoptions that would minimize anysignificant impact of a rule on smallentities. Because this action isderegulatory and imposes no new

burdens, the agency certifies that theproposed rule will not have a significanteconomic impact on a substantial

number of small entities.Section 202(a) of the Unfunded

Mandates Reform Act of 1995 requiresthat agencies prepare a writtenstatement, which includes anassessment of anticipated costs and

benefits, before proposing any rule thatincludes any Federal mandate that mayresult in the expenditure by State, local,and tribal governments, in the aggregate,or by the private sector, of $100,000,000or more (adjusted annually for inflation)in any one year. The current thresholdafter adjustment for inflation is $127million, using the most current (2006)

Implicit Price Deflator for the GrossDomestic Product. FDA does not expectthis proposed rule to result in any 1-year expenditure that would meet orexceed this amount.

Background

An MDDS is a device thatelectronically stores, transfers, displays,or reformats patient medical data. Itdoes not provide any diagnostic orclinical decision making functions. AMDDS could, for example, store alarmdata being generated by a connected

medical device, but would not be ableto generate alarms on its own. TheMDDS device is currently classified intoclass III, the highest level of regulatoryoversight. The MDDS was initiallyplaced in this classification by default.MDDS manufacturers, as makers of classIII devices, bear all costs associated withpremarket approval, including the cost

of submitting the premarket approvalapplication (PMA) and payment of userfees. The costs associated with thesubmission of the PMA are substantial,potentially reaching $1,000.000.

Although we can identify severalMDDS devices and devicemanufacturers, we nevertheless do notknow the size of the affected industry

because FDA has not been enforcingregistration and listing requirements formanufacturers of MDDS devices. Wewelcome comment on the size and othercharacteristics of the affected industry.

FDA is proposing to reclassify MDDSdevices from class III to class I. Basedon the history of use of this type ofdevice in clinical practice and on theexperience of FDA reviewers, theagency concludes that in the hands of ahealthcare professional, a MDDS is safeand effective under general controls.The application of general controls,including the software design controlsin part 820, would be consistent withthe principle of applying the leastdegree of regulatory control necessary toprovide reasonable assurance of safetyand effectiveness. The application ofthis lowest level of regulatory oversightwould be consistent with the treatment

of other devices with similar riskprofiles. Software used to store,transmit, and communicate patientmedical data, such as LaboratoryInformation Systems and Medical ImageCommunication Systems, is typicallyclassified into class I.

FDA has already recognized that theclass III requirements are not necessaryfor ensuring the safety and effectivenessof MDDS devices and has beenexercising enforcement discretion withMDDS device manufacturers. Thesefirms have not been required to submitPMAs or meet other requirements

typically required of manufacturers ofclass III devices, but the agency believesthat all or nearly all firms in thisindustry have in place good businesspractices, including quality systems. IfFDA were to discontinue enforcementdiscretion, most firms would continueto comply with the class I provisions.

Cost of the Proposed Regulation

This proposed regulation isderegulatory. Device manufacturerscurrently subject to class IIIrequirements would be subject to the



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less burdensome requirements formakers of class I devices. Of course,changing the device classification maynot have an impact on the practices ofMDDS device manufacturers as long asFDA continues its practice ofenforcement discretion. For the purposeof this analysis, however, we assumethat enforcement discretion would not

be permanent. The regulatoryalternatives are therefore class III, II, orI controls, enforced by the agency. Thisproposed rule would re-classify MDDSdevices as class I, which would reducethe applicable regulatory requirements.

Manufacturers of class I devices arerequired to: (1) Register and list theirMDDS devices with the agency, (2)conform to applicable medical devicecurrent good manufacturing practicerequirements (part 820), (3) comply withMedical Device Reporting (MDR)requirements (21 CFR part 803), and (4)submit a premarket notification for the

device unless it is exempt. Thisproposed rule proposes to exemptMDDS devices unless they are indicatedfor use by someone other than ahealthcare professional, performirreversible data compression, or exceedthe limitations in 880.9. MDDSdevices indicated for use solely by ahealthcare professional, are exemptfrom the premarket notificationrequirements.

Registration and listing. The majorityof manufacturers of MDDS deviceswould incur a cost to register and listtheir devices with the agency. Weestimate this burden to be less than 1

hour per year for manufacturers familiarwith this requirement, and up to 2 hoursof time for manufacturers not currentlyproducing any FDA-regulated devices.Manufacturers would also face user feesof $1,708 in fiscal year (FY) 2008 toregister and list their devices with theagency. These fees would rise to $2,364in 2012.

Current Good ManufacturingPractices (CGMP)/Quality SystemRegulation (QSR) compliance/MedicalDevice Reporting. Based on experiencewith this and similar devices, FDA

believes that most manufacturers of

these devices already have qualitysystems in place as part of goodbusiness practices. Good qualitysystems would include complaint-handling procedures. FDAs QSR (part820) requirements are very flexible andFDA believes that these manufacturerswill be able to conform their systems toFDA requirements with little difficultyor cost. Manufacturers are alreadyrequired to report to FDA wheneverthey learn that their device may havecaused or contributed to a death orserious injury to a patient. The cost of

complying with these requirementswould be small, but would varydepending on the number and nature ofthe devices manufactured and thenature of the firms current qualitysystem. Firms with existing qualitysystems should be able to adapt theircomplaint procedures to incorporateMDR reporting with little difficulty.

Based on our understanding of theindustry and that it has in placemeasures to ensure quality, we believemost firms would be able to adapt theirsystems to meet FDAs QSR and MDRregulations for no more than $20,000.Again, this would not be a cost imposed

by this proposed rule, but the cost of anexisting burden manufacturers may nothave incurred because FDAs practice ofenforcement discretion withmanufacturers of MDDS devices.

Premarket notification. If FDAfinalizes the classification of MDDSdevices into class I, a manufacturer of a

MDDS device that is indicated for usesolely in a health care facility would notneed to comply with the PMArequirement that applies to class IIIdevices or submit a premarketnotification. FDA is unaware of anyMDDS devices that are not intended foruse solely by healthcare professionals,so we believe all or nearly all MDDSdevices will be exempt from premarketreview. A manufacturer of a MDDSdevice that is indicated for use byanyone other than a healthcareprofessional or that performsirreversible data compression wouldneed to submit a premarket notification,

but the burden of submitting apremarket notification is substantiallyless than that of submitting a PMA. Apremarket notification for a MDDSdevice would be far less complex thana PMA. The cost of preparing andsubmitting such a notification would beseveral thousand dollars. The user feesfor a premarket notification would be$3,404 for FY 2008, increasing to $4,717in 2012. In contrast, the cost ofsubmitting a PMA can reach $1,000,000,plus user fees of an additional $185,000in FY 2008, increasing to $256,384 in2012.

In summary, this devicereclassification would substantiallyreduce an existing burden on themanufacturers of MDDS devices. Theregulatory burden of compliance withthe general controls provisionsapplicable to the manufacturers of allclass I devices is attributable to statutoryrequirements that already apply buthave not been enforced. Assuming thatcontinued enforcement discretion is nota viable long-term regulatory alternative,the proposed rule would reduce theregulatory burden for manufacturers of

MDDS devices. Considering the cost ofsubmitting a PMA plus the relevant userfees, the reduction could be $1,000,000per device.

The Regulatory Flexibility Actrequires agencies to analyze regulatoryoptions that would minimize anysignificant impact of a rule on smallentities. Because reclassification of theaffected devices from class III to class Iwould relieve manufacturers of the costof complying with the premarketapproval requirements of section 515 ofthe act (21 U.S.C. 360e), the agency doesnot believe that this proposed rulewould have a significant economicimpact on a substantial number of smallentities. FDA requests comment on thisissue.

XI. Paperwork Reduction Act of 1995

This proposed rule containsinformation collection provisions thatare subject to review by OMB under the

Paperwork Reduction Act of 1995 (thePRA) (44 U.S.C. 35013520). Thecollections of information addressed inthe proposed rule have been approved

by OMB in accordance with the PRAunder the QSR (part 820, OMB ControlNo. 09100073) and the regulationsgoverning premarket notificationsubmissions (21 CFR part 807, subpartE, OMB Control No. 09100120).

XII. Federalism

FDA has analyzed this proposed rulein accordance with the principles setforth in Executive Order 13132. FDA

has determined that the proposed rule,if finalized, would not contain policiesthat would have substantial directeffects on the States, on the relationship

between the National Government andthe States, or on the distribution ofpower and responsibilities among thevarious levels of government.Accordingly, the agency tentativelyconcludes that the proposed rule doesnot contain policies that havefederalism implications as defined inthe Executive order and, consequently,a federalism summary impact statementhas not been prepared.

XIII. Submission of CommentsInterested persons may submit to the

Division of Dockets Management (seeADDRESSES) written or electroniccomments regarding this document.Submit a single copy of electroniccomments or two paper copies of anymailed comments, except thatindividuals may submit one paper copy.Comments are to be identified with thedocket number found in brackets in theheading of this document. Receivedcomments may be seen in the Division



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of Dockets Management between 9 a.m.and 4 p.m., Monday through Friday.

Please note that on January 15, 2008,the FDA Web site transitioned to theFederal 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 underauthority delegated to the Commissionerof Food and Drugs, FDA proposes toamend 21 CFR part 880 as follows:

PART 880GENERAL HOSPITAL ANDPERSONAL USE DEVICES

1. The authority citation for 21 CFRpart 880 continues to read as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e,360j, 371.

2. Part 880 is amended in subpart Gby adding 880.6310 to read as follows:

880.6310 Medical Device Data System.

(a) Identification. (1) A medicaldevice data system (MDDS) is a deviceintended to provide one or more of thefollowing uses:

(i) The electronic transfer or exchangeof medical device data from a medicaldevice, without altering the function orparameters of any connected devices.

(ii) The electronic storage andretrieval of medical device data from amedical device, without altering the

function or parameters of connecteddevices.(iii) The electronic display of medical

device data from a medical device,without altering the function orparameters of connected devices.

(iv) The electronic conversion ofmedical device data from one format toanother format in accordance with apreset specification.

(2) Medical device data consists ofnumerical or other information availablefrom a medical device in a form suitablefor processing by computer. Medicaldevice data can represent any type of

information or knowledge, e.g., clinicalvalues, alarm conditions, errormessages. This identification does notinclude a device that creates diagnostic,decision support, or alarm functions. Italso does not include the report-writingfunctions of a data system that allowsfor the manual input of data bypractitioners. This identification doesnot include devices with any real time,active, or online patient monitoring.

(b) Classification. Class I (generalcontrols). When the device is indicatedfor use only by a healthcare professional

and does not perform irreversible datacompression, it is exempt from thepremarket notification procedures insubpart E of part 807, subject to thelimitations in 880.9. When the deviceis indicated to be prescribed by ahealthcare professional for use by a layuser, or performs irreversible datacompression, or for over-the-counter use

by a lay user, the device requires thesubmission and clearance of apremarket notification.

Dated: January 25, 2008.

Daniel G. Schultz,

Director, Center for Devices and RadiologicalHealth.

[FR Doc. E82325 Filed 2708; 8:45 am]

BILLING CODE 416001S

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Part 1

[REG15358906]

RIN 1545BG34

Time and Manner for Electing CapitalAsset Treatment for Certain Self-Created Musical Works

AGENCY: Internal Revenue Service (IRS),Treasury.

ACTION: Notice of proposed rulemakingby cross-reference to temporaryregulation.

SUMMARY: In the Rules and Regulationssection of this issue of the FederalRegister, the IRS is issuing a temporaryregulation that provides the time andmanner for making an election to treatthe sale or exchange of musicalcompositions or copyrights in musicalworks created by the taxpayer (orreceived by the taxpayer from theworks creator in a transferred basistransaction) as the sale or exchange ofa capital asset. The temporary regulationreflects changes to the law made by theTax Increase Prevention andReconciliation Act of 2005 and the TaxRelief and Health Care Act of 2006. The

temporary regulation affects taxpayersmaking the election under section1221(b)(3) of the Internal Revenue Code(Code) to treat gain or loss from such asale or exchange as capital gain or loss.The text of the temporary regulationalso serves as the text of this proposedregulation.

DATES: Written or electronic commentsand requests for a public hearing must

be received by May 8, 2008.

ADDRESSES: Send submissions to:CC:PA:LPD:PR (REG15358906), room

5203, Internal Revenue Service, PO Box7604, Ben Franklin Station, Washington,DC 20044. Submissions may be handdelivered Monday through Friday

between the hours of 8 a.m. and 4 p.m.to: CC:PA:LPD:PR (REG15358906),Couriers Desk, Internal RevenueService, 1111 Constitution Avenue,NW., Washington, DC, or sent

electronically via the FederaleRulemaking Portal atwww.regulations.gov (IRS REG15358906).

FOR FURTHER INFORMATION CONTACT:Concerning the proposed regulation,

Jamie Kim, (202) 6224950; concerningsubmission of comments or requesting ahearing, [email protected], (202) 6227180 (not toll-freenumbers).

SUPPLEMENTARY INFORMATION:

Background and Explanation ofProvisions

Temporary regulation in the Rulesand Regulations section of this issue ofthe Federal Register amends the IncomeTax Regulations (26 CFR part 1) relatingto section 1221(b)(3) of the InternalRevenue Code (Code). The temporaryregulation provides rules regarding thetime and manner for making an electionunder section 1221(b)(3) to treat the saleor exchange of certain musicalcompositions or copyrights in musicalworks as the sale or exchange of acapital asset. The text of the temporaryregulation also serves as the text of thisproposed regulation. The preamble to

the temporary regulation explains theamendments.

Special Analyses

It has been determined that this noticeof proposed rulemaking is not asignificant regulatory action as definedin Executive Order 12866. Therefore, aregulatory assessment is not required. Italso has been determined that section553(b) of the Administrative ProcedureAct (5 U.S.C. chapter 5) does not applyto this regulation, and because theregulation does not impose a collectionof information on small entities, the

Regulatory Flexibility Act (5 U.S.C.chapter 6) does not apply. Pursuant tosection 7805(f) of the Internal RevenueCode, this regulation has beensubmitted to the Chief Counsel forAdvocacy of the Small BusinessAdministration for comment on itsimpact on small business.

Comments and Requests for a PublicHearing

Before this proposed regulation isadopted as a final regulation,consideration will be given to any

http://www.regulations.gov/mailto:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]:[email protected]://www.regulations.gov/

proposed fda regulation of medical device data systems

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