12/4/2015
`
`Medical Device Databases
`
`U.S. Food and Drug Administration
`Protecting and Promoting Your Health
`
`Medical Device Databases
`Title
`AooessGUDlD (Global Unique Device Identification Database)
`(htip:lIaocessgudId.nlm.nIh.govI)
`
`Advisory Coinmltuelhnoi Meetings - CDRH
`(htipzllwww.aoeessdata.lda.govI:criptsIodriIIcfdocslctAdvisoryIeearcii.c1m)
`
`CDRH Inspections Damhase
`(htipzllwww.acoessdata.fda.govIsorims/cdrhlcfdo¢sIcfl'PLcIlnspcct.cfm)
`
`CFR Title 21 - Food and Drugs
`(|1tlp:I/www.aocessdah.fda.gevIsA:riptsIedflIIcfdocsIcfcfrIcfrsearch.dm)
`
`Description
`This database
`contains key
`device
`Identification
`information
`submitted to
`the FDA about
`medical
`devices that
`have Unique
`Device
`lderriiiiers
`(UDI).
`This database
`contains
`historical
`information
`about CDRH
`Advisory
`Committees
`and Panel
`meetings
`through 2008,
`including
`summaries
`and
`transcripts.
`The CDRH
`inspections
`Database
`provides
`irrfonnation
`about medcal
`device
`inspections
`that were the
`responsibility
`of CDRH from
`2008 to the
`present.
`This database
`contains the
`most recent
`revision from
`
`Updated
`Daily
`
`More lnfonnaiion
`More about GUDID (mledicalDovioeslneviceReguIationandGuidanceIUniqueDovioelderitificationIGIobalUDIDa1abaseGUDIDIucm20088750.Mm)
`
`FDA Advisory committees and Meeting Materials (lAdvlsoryCoinmIttecsIcornmitue|Mco1ingMatIrial5IdefeulI.h1in)
`
`No longer
`being
`updated
`
`Weekly
`
`More CDRH Inspections Database (IAhoutFDAlCenihetsOliiceslofiiceofledlcalProduclsandTohaoeoICDRHIcDRHTransparencyIuom223110.Mm)
`
`Annually Mon About 21cFR (IMedlcalDevioeslDtvlceRoguIationandGuldanoelDaubascsIucm135680.htm)
`
`Ex. 2039-0001
`
`
`
`Medical Device Databases
`
`U.S. Food and Drug Administration
`Protecting and Promoting Your Health
`
`Medical Device Databases
`Title
`AooessGUDlD (Global Unique Device Identification Database)
`(htip:lIaocessgudId.nlm.nIh.govI)
`
`Advisory Coinmltuelhnoi Meetings - CDRH
`(htipzllwww.aoeessdata.lda.govI:criptsIodriIIcfdocslctAdvisoryIeearcii.c1m)
`
`CDRH Inspections Damhase
`(htipzllwww.acoessdata.fda.govIsorims/cdrhlcfdo¢sIcfl'PLcIlnspcct.cfm)
`
`CFR Title 21 - Food and Drugs
`(|1tlp:I/www.aocessdah.fda.gevIsA:riptsIedflIIcfdocsIcfcfrIcfrsearch.dm)
`
`Description
`This database
`contains key
`device
`Identification
`information
`submitted to
`the FDA about
`medical
`devices that
`have Unique
`Device
`lderriiiiers
`(UDI).
`This database
`contains
`historical
`information
`about CDRH
`Advisory
`Committees
`and Panel
`meetings
`through 2008,
`including
`summaries
`and
`transcripts.
`The CDRH
`inspections
`Database
`provides
`irrfonnation
`about medcal
`device
`inspections
`that were the
`responsibility
`of CDRH from
`2008 to the
`present.
`This database
`contains the
`most recent
`revision from
`
`Updated
`Daily
`
`More lnfonnaiion
`More about GUDID (mledicalDovioeslneviceReguIationandGuidanceIUniqueDovioelderitificationIGIobalUDIDa1abaseGUDIDIucm20088750.Mm)
`
`FDA Advisory committees and Meeting Materials (lAdvlsoryCoinmIttecsIcornmitue|Mco1ingMatIrial5IdefeulI.h1in)
`
`No longer
`being
`updated
`
`Weekly
`
`More CDRH Inspections Database (IAhoutFDAlCenihetsOliiceslofiiceofledlcalProduclsandTohaoeoICDRHIcDRHTransparencyIuom223110.Mm)
`
`Annually Mon About 21cFR (IMedlcalDevioeslDtvlceRoguIationandGuldanoelDaubascsIucm135680.htm)
`
`Ex. 2039-0001
`
`
`
`12/4/2015
`
`Medical Device Databases
`
`Weekly
`
`Clinical Laboratory Improvement Amendments - Download Data (IMedicalDeviceslDeviceRegulationandeuidancelbatabaseslucm142431.htm)
`
`Monthly
`
`CLIA Waivers (IMedica|DevicesIDeviceRegu|ationandGuidanceIIVDReguIatoryAssistanceIucm393233.htrn)
`
`Clinical Laboratory Improvement Amendments (CLIA)
`(http:IIwww.acoessdata.fda.govIscriptslcdrhlcfdocslcfcL|AIc|ia.cfm)
`
`CLIA Currently Waived Analytles
`(http:l/www.accessdata.fda.govIscriptslcdrhlcfdocsIcfC|ialanalyleswaived.cfrn) lg:
`(http:IIwww.fda.govIAboutFDAIAboutThisWehsiteIWebsitlePo|iciesIDiscIaimersIdefauIt.htrn)
`
`De Novo (http:lIwww.aooessdata.fda.govIscriptsIcdrhIcfdocsIcfPMNIdenovo.cfm)
`
`This database
`contains the
`commercially
`marketed in
`viii!) test
`systems
`categorized by
`the FDA since
`January 31,
`2000, and
`tests
`categorized by
`the Centers for
`Disease
`Control and
`Prevention
`(CDC) prior to
`that date.
`This database
`contains the
`commercially
`marketed in
`vitro test
`systems
`categorized as
`CLIA waived
`by the FDA
`since January
`31, 2000, and
`by the Centers
`for Disease
`Control and
`Prevention
`(CDC) prior to
`that date.
`CLIA waived
`test systems
`are waived
`from certain
`CLIA
`laboratory
`requirements
`(42 CFR Part
`493).
`De novo
`provides a
`possible route
`to classify
`novel devices
`of low to
`moderate risk.
`This database
`contains de
`
`Ex. 2039-0002
`
`
`
`12/4/2015
`
`Medical Device Databases
`
`Humanitarian Device Exemption (HDE)
`(http:l/www.aoeessdata.tda.gov/scrlptsledrhlcfdocslctl-lDEIhde.cfm)
`
`IVD Home Use Lab Tests (Over The Counter) Tests
`(http:IIwww.aooessdata.fda.govIscrlptslcdrhlcfdocslcflvblsearchcfm)
`
`MAUDE (Manufacturer and User Faclllly Devloe Experience)
`(http:IIwww.accessdata.fda.govIscriptsIcdrhIr:fdoosIc1MAUDEIsearch.CFM)
`
`numnnsuauun
`(FDA) as
`meeting
`baseline
`quality
`standards for
`equipment.
`personnel and
`practices
`under the
`Mammography
`Quality
`Standards Act
`of 1992
`(MQSA).
`Searchable
`listing of
`Humanitarian
`Device
`Exemption
`(HDE) Class
`II I medical
`devices.
`
`Searchable
`listing of Over-
`the-Counter
`tests (OTC)
`and collection
`kits that have
`been cleared
`or approved by
`the FDA
`
`Weekly
`
`More about Humanitarian Device Exemption (HDE)
`(http://www.lda.govlMedIcaIDevleesIDevleeReguIatlonandeuldance/HowtoMarketYournevloelhemarkstsubmlsslonslflurnanItarlanDevIoeExemptlonldefauIt.htm)
`
`Weekly
`
`More about Home Use Lab Tests (lMedica|DeviceslProductsandMedica|ProceduresllnVit1oDiagnosticslHomeUseTestsIdefau|t.htrn)
`
`MAUDE data Weekly
`represents
`reports of
`adverse
`events
`involving
`medical
`devices. The
`data consists
`of all voluntary
`reports since
`June. 1993,
`user facility
`reports since
`1991,
`distributor
`reports since
`1993. and
`manufacturer
`reports since
`August, 1996.
`
`Ex. 2039-0003
`
`
`
`12/4/2015
`
`Medical Device Databases
`
`Premarket Approvals (PMA)
`(htIp:IIwvIw.aooessdala.lda.govIscrlptsIcdrl1Ir:fdocsIc1PMAIprna.c1vn)
`
`Premarket Approval (PMA) Summary Review Memos for 130-Day Design changes
`(l1Itp:IIwww.aooessdala.fda.govIscrlptslcdrhlcfdocslcfpmalpmamemoscfrn)
`
`serious injury
`during the
`years 1992
`through 1996.
`
`effectiveness
`01 all devices
`classified as
`Class III
`devices. An
`approved
`Premarket
`Approval
`Application
`(PMA) is, in
`effect, a
`private license
`granted to the
`applicant for
`marketing a
`particular
`medical
`device. This
`database may
`be searched
`by a variety of
`fields and is
`updated once
`a week.
`
`A 180-day
`supplement is
`a request for a
`significant
`change in
`components.
`materials,
`design,
`specification,
`software, color
`additive, and
`labeling to an
`approved
`premarket
`application or
`premarket
`
`File Description for the CDRH Releasable (Approved) PMAs (IMed|i:alDevloesIDevloekegulatlonandGu|dancdDatal:asesIucm135279.|1tm)
`
`Weekly
`
`More about Premarket Approval (PMA) Summary Review Memos for 180-Day Design Changes
`(IAboulFDAlCenleIs0flloesI0tlloeolllfiedIoa|ProductsandTobacooICDRHICDRHTransparencyIucm206289.htm)
`
`Ex. 2039-0004
`
`
`
`12/4/2015
`
`Medical Device Databases
`
`Premarket Notifications (510(k)s)
`(ht1p:IIwww.accessdafa.fda.govIscriptsIodrhIcfdocsIc1PMNIpmn.cfm)
`
`Product Classification
`(hltp:llwww.accessdau.fda.gov/scriptdtslcdrhlcfdocslctlicD/PCDSimpleSearch.cfrn)
`
`relating to
`design
`changes.
`Medical device Weekly
`manufacturers
`are required to
`submit a
`premarket
`notification or
`510(k) if they
`intend to
`introduce a
`device into
`commercial
`distribution for
`the first time or
`reintroduce a
`device that will
`be significantly
`changed or
`modified to the
`extent that its
`safety or
`effectiveness
`could be
`affected. This
`database of
`releasable
`510(k)s can be
`searched by
`510(k) number,
`applicant,
`device name
`or FDA
`product code.
`Summaries of
`safety and
`effectiveness
`information is
`available via
`the web
`interface for
`more recent
`records. The
`database is
`updated once
`awfim
`
`This database Weekly
`contains
`medical device
`names and
`associated
`information
`
`More about Product Code Classification Database (IMedicaIDevicesIDeviceReguIalionarrdGuidarroeIOverviewICIassifyYourDevioeIucm051631.h1m)
`
`Ex. 2039-0005
`
`
`
`12/4/2015
`
`Medical Device Databases
`
`Radiation-emitting Electronic Product Codes
`(http:IIwww.aooessdata.fda.govIscrlptslcdrhIcfdol:slc1PcD_rhITextSearch.ctm)
`
`Radiation Emitting Product Corrective Actions and Recalls
`(http://www.accessdata.fda.gov/scrlplsIodrhIcfdocsIc1PcD_RH/rh_res.ctm)
`
`Recall: of Medical Devices
`(http:IIwww.aooessdata.tda.gov/scriptsIodrhIcfdocsIctRES/res.¢fm)
`
`This database Weekly
`contains
`product names
`and associated
`information
`developed by
`the Center for
`all products,
`both medical
`and non-
`medical, which
`emit radiation.
`It includes a
`three letter
`product code,
`a descriptor tor
`radiation type,
`applicable
`performance
`standard(s),
`and a definition
`for the code.
`
`This database
`provides
`descriptions of
`radiation-
`emitting
`products that
`have been
`recalled under
`an approved
`corrective
`action plan to
`remove
`defective and
`noncompliant
`products from
`the market.
`Searches may
`be done by
`manufacturer
`name,
`perfonnance
`standard,
`product name,
`description. or
`date range.
`This database
`contains a list
`of classified
`medical device
`recalls since
`November 1.
`2002
`
`More About Corrective Actions (IMedica|Devices]DeviceRegulationandGuidanoeIDatahasesIucm300234.him)
`
`Ex. 2039-0006
`
`
`
`12/4/2015
`
`Medical Device Databases
`
`Total Product Life cycle (TPLC)
`(l1ttp:IIwww.amessdata.fda.govIscrlptslcdrhIcfdocsIcf|'PLCItp|c.cfm)
`
`..... .3,
`.....
`assembly. or
`processing of
`medical
`devices
`intended for
`human use
`and
`commercial
`distribution)
`and listings of
`medical
`devices in
`commercial
`distribution by
`both domestic
`and foreign
`manufacturers.
`Note: This
`database is
`updated once
`a week.
`
`The Total
`Product Life
`Cycle (TPLC)
`database
`integrates
`premarket and
`postmarket
`data about
`medical
`devices. It
`includes
`information
`pulled from
`CDRH
`databases
`including
`Premarket
`Approvals
`(PMA),
`Premarket
`Notifications
`(510[k]).
`Adverse
`Events, and
`Recalls. You
`can search the
`TPLC
`database by
`device name
`or procode to
`receive a full
`report about a
`particular
`
`Weekly
`
`More about TPLC (IAboutFDAIcenters0ftioesIOttioeottinedica|ProductsandTobaooo/cDRHICDRHTransparency/ucm199906.htm)
`
`Ex. 2039-0007
`
`
`
`12/4/2015
`
`Medical Device Databases
`
`the information
`the Center can
`use to make
`an appropriate
`decision
`regarding the
`clearance or
`approval of a
`submission.
`Information
`submitted on
`conformance
`with such
`standards will
`have a direct
`bearing on
`safety and
`effectiveness
`determinations
`made during
`the review of
`IDES, HDEs,
`PMAs, and
`PDPS.
`Conformance
`with
`recognized
`consensus
`standards in
`and of itself.
`however, may
`not always be
`a sufficient
`basis for
`regulatory
`decisions.
`
`Federal
`regulations
`require that an
`assembler who
`installs one or
`more certified
`components of
`a diagnostic x-
`ray system
`submit a report
`of assembly.
`This database
`contains the
`releasable
`information
`submitted
`including
`
`X-Ray Assembler Data
`(httpzl/www.aoeessdata.fda.gov/scriptsIodrhIcfdocsIcfAssernlassembIer.cfm)
`
`Annually
`
`X-Ray Assembler Data File (MedicalDevioeslbevioeRegu|alionandGuidanoeIDafaba.sesIucm135419.l1lm)
`
`Ex. 2039-0008
`
`
`
`12/4/2015
`
`Medical Device Databases
`
`More in Medical Device Databases
`(IMedicalDevicesIDeviceRegulationandGuidanceIDalabasesIdefau|t.htm[
`
`Ex. 2039-0009
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