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

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

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

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

  2. Emerging Technology Trends CDRH TECHNOLOGY FORECAST • Computer-related Technology • Molecular Medicine • Home- and Self-care • Minimally Invasive Procedures • Device/Drug Products • Organ Replacements and Assists http://www.fda.gov/cdrh/ost/trends/toc.html

  3. Survey Participants Robert Abodeely James Allen Clement Bezold Pfizer - MTGAMA Institute for Alternative Futures Stephen 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 FoundationKaiser-Permanente Harvard University Anthony J. Montagnolo Robert M. Nerem Charles H. Swanson ECRI Ga. Inst. Of Tech. Medtronic

  4. Medical Device Technology Drivers • Demographic trends • Economic trends • Technology trends

  5. Computer-related device trends • Substantial new product development 5-10 yrs • Integrated patient medical information systems • Smart cards • Computer-aided medical decisionmaking • Smart artificial organ implants • Miniaturized biosensors & sensor “fusion” • Customized microprocessor devices

  6. Homecare technology trends • Substantial new product development 5-10 yrs • Limited expectations for advanced technologies • Monitoring -- blood, urine, drug concentrations • Simplified drug delivery systems • Telemedicine • Smart devices

  7. Home Care Technologies for the 21st Century • NSF-FDA Workshop • - 150 participants • - Industry • - Academia • - Government • - Clinicians • - Providers

  8. 21st Century Home Care Technology • Prevention-oriented devices • Consumer health model • Noninvasive sensors • Smart devices • Customized products, flexible configurations • Data analysis tools for medical decisions • Electronic patient records • Wearable products • Wireless net-linked systems

  9. US 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

  10. CDRH Focus Ensuring the safety and effectiveness of medical devices

  11. FDA’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)

  12. 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

  13. Device Classification • 1700 generic types of devices • Three Classes • - Class I • - Class II • - Class III • intended use; intended user • Classification determines extent of regulatory • control

  14. Device Classification Risk Low Medium High • Class I • - General Controls • Class II • - General Controls and • Special Controls • Class III • - General Controls and • Premarket Approval

  15. Premarket 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

  16. Premarket 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

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

  18. FDA’s Framework -- The traditional strategy • Regulatory gatekeeper • Unilateral responsibilities • Reactive orientation

  19. FDA’s Framework -- The emerging strategy • Multifaceted, information-based strategy • Collaborative multi-party harmonization • Anticipatory orientation

  20. eHealth Technology Issues • What’s a Device? • Labeling • “Smart Devices” • Tele-health • Interacting Systems of Devices • Architectural Considerations • Environmental Factors

  21. Action Groupings Regulatory mandate SIGNIFICANT POLICY REQUIREMENTS - NEW - UPDATED MINIMALISM EDUCATION INFORMATION COLLABORATIONS NO ACTION NEGLIGIBLE NEGLIGIBLE SIGNIFICANT Public health issues

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