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Office of Science and TechnologyOffice of Science and TechnologyCenter for Devices and Radiological Health, FDACenter for Devices and Radiological Health, FDA
William A. HermanWilliam A. Herman
eHealth Technologies and the FDAeHealth Technologies and the FDA
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CDRH TECHNOLOGY FORECASTCDRH TECHNOLOGY FORECAST• Computer-related TechnologyComputer-related Technology• Molecular MedicineMolecular Medicine• Home- and Self-careHome- and Self-care• Minimally Invasive ProceduresMinimally Invasive Procedures• Device/Drug ProductsDevice/Drug Products• Organ Replacements and AssistsOrgan Replacements and Assists
http://www.fda.gov/cdrh/ost/trends/toc.htmlhttp://www.fda.gov/cdrh/ost/trends/toc.html
Emerging Technology TrendsEmerging Technology Trends
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Robert Abodeely James Allen Clement Bezold Pfizer - MTG AMA Institute for Alternative FuturesStephen P. Bruttig Joseph F. Coates Gilbert B. Devey U.S. Army Coates and Jarrett NSF
Henry S. Eden Don Giddens Harry Handlesman NIH Ga. Inst. Of Tech. AHCPR
Peter Katona Ian H. Leverton Barbara McNeil Whitaker Foundation Kaiser-Permanente Harvard University
Anthony J. Montagnolo Robert M. Nerem Charles H. Swanson ECRI Ga. Inst. Of Tech. Medtronic
Survey Survey ParticipantsParticipants
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Medical Device Technology DriversMedical Device Technology Drivers
• Demographic trends• Economic trends• Technology trends
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Computer-related device trendsComputer-related device trends
• Substantial new product development 5-10 yrsSubstantial new product development 5-10 yrs• Integrated patient medical information systemsIntegrated patient medical information systems• Smart cardsSmart cards• Computer-aided medical decisionmakingComputer-aided medical decisionmaking• Smart artificial organ implantsSmart artificial organ implants• Miniaturized biosensors & sensor “fusion”Miniaturized biosensors & sensor “fusion”• Customized microprocessor devicesCustomized microprocessor devices
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Homecare technology trendsHomecare technology trends
• Substantial new product development 5-10 yrsSubstantial new product development 5-10 yrs• Limited expectations for advanced technologiesLimited expectations for advanced technologies• Monitoring -- blood, urine, drug concentrationsMonitoring -- blood, urine, drug concentrations• Simplified drug delivery systemsSimplified drug delivery systems• TelemedicineTelemedicine• Smart devicesSmart devices
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Home Care Technologies for theHome Care Technologies for the2121stst Century Century
• NSF-FDA WorkshopNSF-FDA Workshop - 150 participants- 150 participants
- Industry- Industry - Academia- Academia - Government- Government - Clinicians- Clinicians - Providers- Providers
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2121stst Century Home Care Technology Century Home Care Technology
• Prevention-oriented devicesPrevention-oriented devices• Consumer health modelConsumer health model• Noninvasive sensorsNoninvasive sensors• Smart devicesSmart devices• Customized products, flexible configurationsCustomized products, flexible configurations• Data analysis tools for medical decisionsData analysis tools for medical decisions• Electronic patient recordsElectronic patient records• Wearable productsWearable products• Wireless net-linked systemsWireless net-linked systems
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US Food & Drug AdministrationUS Food & Drug Administration
• Center for Drugs• Center for Food Safety and Applied Nutrition• Center for Biologics• Center for Veterinary Medicine• Center for Devices and Radiological Health• National Center for Toxicological Research• Office of Regional Affairs
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CDRH FocusCDRH Focus
Ensuring the safety and effectiveness of medical devices
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FDA’s Mandate for RegulationFDA’s Mandate for Regulation
• Medical Device Amendments (1976)• Regulations implementing FD&C Act
- Title 21 Code of Federal Regulations
(21CFR) Parts 800 – 1299• Safe Medical Devices Act (1990)• FDA Modernization Act (1997)
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What is a medical device?What is a medical device?
• Diagnosis, cure, mitigation, treatment or prevention of disease or condition
• Affects the structure and function of the body• Does not achieve intended use through
chemical reaction• Is not metabolized
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Device ClassificationDevice Classification
• 1700 generic types of devices• Three Classes
- Class I - Class II
- Class III• intended use; intended user• Classification determines extent of regulatory control
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Device ClassificationDevice Classification
Class I- General
ControlsClass II
- General Controls and
Special Controls
Class III- General
Controls and Premarket
Approval
Risk
Low
Medium
High
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Premarket approval – 510kPremarket approval – 510k
• Marketing for first time, or significant change to existing device• Demonstration of Substantial Equivalence (SE) to legally marketed device in U.S.• SE means “As safe and as effective”
- engineering- clinical outcome
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Premarket approval – PMAPremarket approval – PMA
• Only applies to Class III devices- New device- Device found not substantially
equivalent• Proof of safety and effectiveness with clinical data• Investigational Device Exemption (IDE) may be desired or required
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Investigational Device Investigational Device ExemptionExemption
• Used for clinical trials• Significant risk devices• Protection of human subjects• Allows sponsor to recoup R&D costs
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FDA’s Framework --FDA’s Framework --The traditional strategyThe traditional strategy
• Regulatory gatekeeper• Unilateral responsibilities• Reactive orientation
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FDA’s Framework --FDA’s Framework --The emerging strategyThe emerging strategy
• Multifaceted, information-based strategy• Collaborative multi-party harmonization• Anticipatory orientation
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eHealth Technology IssueseHealth Technology Issues
• What’s a Device?What’s a Device?• LabelingLabeling• “ “Smart Devices”Smart Devices”• Tele-healthTele-health• Interacting Systems of Interacting Systems of DevicesDevices• Architectural ConsiderationsArchitectural Considerations• Environmental FactorsEnvironmental Factors
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Action GroupingsAction Groupings
Public health issues
NEGLIGIBLE SIGNIFICANT
Reg
ulat
ory
man
date
NE
GL
IGIB
LE
SIG
NIF
ICA
NT
NO ACTION
EDUCATIONINFORMATIONCOLLABORATIONS
MINIMALISMPOLICY REQUIREMENTS - NEW - UPDATED