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Office of Science and Technology Office of Science and Technology Center for Devices and Radiological Health, Center for Devices and Radiological Health, FDA FDA William A. William A. Herman Herman Health Technologies and the FDA Health Technologies and the FDA

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eHealth Technologies and the FDA. Office of Science and Technology Center for Devices and Radiological Health, FDA. William A. Herman. Emerging Technology Trends. CDRH TECHNOLOGY FORECAST Computer-related Technology Molecular Medicine Home- and Self-care Minimally Invasive Procedures - PowerPoint PPT Presentation

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Page 1: Office of Science and Technology Center for Devices and Radiological Health, FDA

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

Page 2: Office of Science and Technology Center for Devices and Radiological Health, FDA

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

Page 3: Office of Science and Technology Center for Devices and Radiological Health, FDA

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

Page 4: Office of Science and Technology Center for Devices and Radiological Health, FDA

Medical Device Technology DriversMedical Device Technology Drivers

• Demographic trends• Economic trends• Technology trends

Page 5: Office of Science and Technology Center for Devices and Radiological Health, FDA

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

Page 6: Office of Science and Technology Center for Devices and Radiological Health, FDA

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

Page 7: Office of Science and Technology Center for Devices and Radiological Health, FDA

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

Page 8: Office of Science and Technology Center for Devices and Radiological Health, FDA

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

Page 9: Office of Science and Technology Center for Devices and Radiological Health, FDA

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

Page 10: Office of Science and Technology Center for Devices and Radiological Health, FDA

CDRH FocusCDRH Focus

Ensuring the safety and effectiveness of medical devices

Page 11: Office of Science and Technology Center for Devices and Radiological Health, FDA

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)

Page 12: Office of Science and Technology Center for Devices and Radiological Health, FDA

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

Page 13: Office of Science and Technology Center for Devices and Radiological Health, FDA

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

Page 14: Office of Science and Technology Center for Devices and Radiological Health, FDA

Device ClassificationDevice Classification

Class I- General

ControlsClass II

- General Controls and

Special Controls

Class III- General

Controls and Premarket

Approval

Risk

Low

Medium

High

Page 15: Office of Science and Technology Center for Devices and Radiological Health, FDA

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

Page 16: Office of Science and Technology Center for Devices and Radiological Health, FDA

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

Page 17: Office of Science and Technology Center for Devices and Radiological Health, FDA

Investigational Device Investigational Device ExemptionExemption

• Used for clinical trials• Significant risk devices• Protection of human subjects• Allows sponsor to recoup R&D costs

Page 18: Office of Science and Technology Center for Devices and Radiological Health, FDA

FDA’s Framework --FDA’s Framework --The traditional strategyThe traditional strategy

• Regulatory gatekeeper• Unilateral responsibilities• Reactive orientation

Page 19: Office of Science and Technology Center for Devices and Radiological Health, FDA

FDA’s Framework --FDA’s Framework --The emerging strategyThe emerging strategy

• Multifaceted, information-based strategy• Collaborative multi-party harmonization• Anticipatory orientation

Page 20: Office of Science and Technology Center for Devices and Radiological Health, FDA

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

Page 21: Office of Science and Technology Center for Devices and Radiological Health, FDA

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


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