regulation of medical devices celia m. witten, ph.d., m.d. director division of general, restorative...
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Regulation of Medical DevicesRegulation of Medical DevicesCelia M. Witten, Ph.D., M.D.Celia M. Witten, Ph.D., M.D.
DirectorDirectorDivision of General, Restorative Division of General, Restorative
andandNeurological DevicesNeurological Devices
Office of Device EvaluationOffice of Device EvaluationFood and Drug AdministrationFood and Drug Administration
RHAIRRHAIR
Society for Academic Emergency Society for Academic Emergency MedicineMedicine
Boston, MassachusettsBoston, Massachusetts
May 31, 2003May 31, 2003
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OutlineOutline
Who we areWho we are Device typesDevice types Paths to marketPaths to market Temperature control devicesTemperature control devices Clinical study regulationClinical study regulation
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FDA
CVM CFSCAN CDRH CBER CDER
OST OSM OSB ODE OHIP OC OIVD
DAGID
DCD
*DGRND
DOED
DRARD
Who We Are
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Device Examples Device Examples
Neuroembolization devicesNeuroembolization devices Deep brain stimulatorsDeep brain stimulators Neurodiagnostic devices (EEG, Neurodiagnostic devices (EEG,
EMG)EMG) Neurosurgical shuntsNeurosurgical shunts Muscle stimulatorsMuscle stimulators Neurovascular stentsNeurovascular stents
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Regulatory Review:Regulatory Review: Pathways to Market Pathways to Market
Premarket Notification 510(k)Premarket Notification 510(k) Premarket Approval Application Premarket Approval Application
(PMA)(PMA) Product Development Protocol Product Development Protocol
(PDP)(PDP) Humanitarian Device Exemption Humanitarian Device Exemption
(HDE)(HDE) De Novo ClassificationDe Novo Classification
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Premarket Notification Premarket Notification 510(k)510(k)
Substantial EquivalenceSubstantial Equivalence Predicate Device (legally Predicate Device (legally
marketed, not subject to PMA)marketed, not subject to PMA) ComparisonComparison
– same intended use andsame intended use and– same technological characteristics orsame technological characteristics or– different technological characteristics different technological characteristics
andand– as safe and effective as predicateas safe and effective as predicate
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Premarket Application Premarket Application (PMA)(PMA)
…”…”reasonable assurance of reasonable assurance of safety and effectiveness”…safety and effectiveness”…
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Regulatory Path Regulatory Path ExamplesExamples
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Hydrocephalus ShuntsHydrocephalus Shunts
510(k) (substantial equivalence)510(k) (substantial equivalence) Comparison to predicateComparison to predicate Standards:Standards:
– ASTM F647ASTM F647– ISO 7197ISO 7197
Materials/biocompatibilityMaterials/biocompatibility For new/unusual designs, may need a For new/unusual designs, may need a
clinical study forclinical study for– InfectionInfection– Revision/causesRevision/causes– Failures/failure modesFailures/failure modes
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Intracranial Neurovascular Intracranial Neurovascular StentsStents
Class III (PMA/HDE/PDP)Class III (PMA/HDE/PDP) 2 HDE’s approved2 HDE’s approved
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Deep Brain StimulationDeep Brain Stimulation
Class IIIClass III PMA approval for essential PMA approval for essential
tremor and Parkinson’s tremor and Parkinson’s disease symptoms disease symptoms
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Clinical Study Clinical Study RegulationRegulation
FFD&C Act gives FDA the FFD&C Act gives FDA the authority to regulate authority to regulate investigational devices:investigational devices:
To To encourageencourage the discovery the discovery and development of new and development of new devicesdevices
Maintain Maintain optimum freedomoptimum freedom for for scientific investigationsscientific investigations
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Section 520(g)Section 520(g)of the Actof the Act
Requires IRB approval for all Requires IRB approval for all clinical investigationsclinical investigations
Requires informed consent Requires informed consent from all subjects unless from all subjects unless emergency useemergency use
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IDE RegulationIDE Regulation(Part 812)(Part 812)
Allows an unapproved device to be Allows an unapproved device to be shipped for clinical evaluation:shipped for clinical evaluation:
Identifies sections of the Act from Identifies sections of the Act from which IDEs are exemptwhich IDEs are exempt
Identifies exempted investigations Identifies exempted investigations (e.g. cleared devices, IVDs)(e.g. cleared devices, IVDs)
Defines SR and NSR investigationsDefines SR and NSR investigations
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Significant Risk (SR) Significant Risk (SR) StudyStudy
Presents a potential serious risk to Presents a potential serious risk to the health, safety, and welfare of a the health, safety, and welfare of a subject and is:subject and is:– an implant; oran implant; or– life supporting or sustaining; orlife supporting or sustaining; or– of substantial importance in of substantial importance in
diagnosing, curing, mitigating, or diagnosing, curing, mitigating, or treating disease or preventing treating disease or preventing impairment of human healthimpairment of human health
FDA approval requiredFDA approval required
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Non-significant Risk Non-significant Risk StudiesStudies
FDA approval not neededFDA approval not needed Examples:Examples:
– MRI < 4 TeslaMRI < 4 Tesla– Urologic cathetersUrologic catheters– Low level biostimulation lasersLow level biostimulation lasers– LaparoscopesLaparoscopes
NSR devices can be SR studiesNSR devices can be SR studies
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Informed Consent: Informed Consent: Emergency UseEmergency Use
Must be reviewed and Must be reviewed and approved by the IRB and the approved by the IRB and the FDA prior to useFDA prior to use
May be waived when there is May be waived when there is a life-threatening situationa life-threatening situation– the subject cannot communicatethe subject cannot communicate– time is not sufficienttime is not sufficient– no available alternativeno available alternative– two physicians certify in writing two physicians certify in writing
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Informed Consent: Informed Consent: Emergency ResearchEmergency Research
Certain studies may not require Certain studies may not require informed consent when IRB agrees informed consent when IRB agrees thatthat– there is a life-threatening situation and there is a life-threatening situation and
currentcurrent
treatments are unsatisfactorytreatments are unsatisfactory– no timeno time– can’t identify subjects prospectively can’t identify subjects prospectively – community consultationcommunity consultation– public disclosurepublic disclosure
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When Are Clinical Data When Are Clinical Data Needed?Needed?
To support:To support: PMA, PDP or HDE (almost always)PMA, PDP or HDE (almost always) 510(k) (<10%)510(k) (<10%) New indication for an New indication for an approvedapproved
device (e.g., BPH for a urologic device (e.g., BPH for a urologic laser)laser)
Significant change to device, Significant change to device, especially Class III devicesespecially Class III devices
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Types of StudiesTypes of Studies
Sponsor-investigatorSponsor-investigator Manufacturer-sponsoredManufacturer-sponsored
– FeasibilityFeasibility– Pivotal, including sites outside Pivotal, including sites outside
the USthe US– Post-approvalPost-approval
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Feasibility TrialFeasibility Trial
Answer design-related questions Answer design-related questions that cannot be addressed by that cannot be addressed by bench/animal testingbench/animal testing
Modify device design &/or Modify device design &/or instructions for useinstructions for use
Preliminary safety dataPreliminary safety data No controlNo control Limited # pts/limited follow-upLimited # pts/limited follow-up
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Pivotal TrialPivotal Trial
Final design, indication for use, Final design, indication for use, and protocoland protocol
ControlledControlled Masked, if possibleMasked, if possible Primary/secondary endpointsPrimary/secondary endpoints Develop information for labelingDevelop information for labeling Statistical validity to show S & EStatistical validity to show S & E
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Post-ApprovalPost-Approval
May be required for PMA May be required for PMA approvalapproval
Designed to address specific Designed to address specific questionquestion
# of patients and duration # of patients and duration specified by FDAspecified by FDA
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Cooling Devices:Cooling Devices:Clinical Study Clinical Study
QuestionsQuestions How soon?How soon? How cold?How cold? How fast?How fast? How long?How long? How measured?How measured? Speed of rewarming?Speed of rewarming? Other treatments provided?Other treatments provided? Local versus systemic?Local versus systemic?
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Temperature Control Temperature Control DevicesDevices
Tool?Tool? Treatment?Treatment?
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Temperature Control Temperature Control DevicesDevices
Cooling BlanketsCooling Blankets Endovascular DevicesEndovascular Devices
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