BIOE 301ScheduleReading Assignment for ThursdayAfter Today’s Lecture…U. S. Department of Health & Human ServicesSlide 6Workings of the FDARole of Center for Devices and Radiological Health (CDRH)Regulation of Medical DevicesMedical Device Act (1976)Class Activity (~5 min)Basic Regulatory RequirementsDevice Approval ProcessSteps in Device Approval ProcessClasses of Devices according to CDRH510(k) vs PMA510(k) Determination Flow ChartPremarket Approval (PMA)Pre-clinical studiesStandardsIDE and Clinical TrialsHumanitarian Use ExemptionMedical Device ReportingSlide 24Recently Approved DevicesDevice Development Costs $$$R&D Funding for Biomedical ResearchNIH Congressional Appropriations FY1997- FY2006Total Research Expenditures at RiceThe NIH OrganizationNIHThe NIBIB VisionA big challenge for the NIBIB is promoting multidisciplinary researchCurrent NIBIB Grant Portfolio AreasNIH Granting ProcessScores and Funding LevelFor More Information, See the Following SourcesIndex CardsDesign Control GuidanceTypes of UniversitiesBIOE 301Lecture Twenty-TwoSchedule•Today, April 10–Lecture 22: FDA Device Regulation & Research Funding •Thursday, April 12–Lecture 23: Future of Bioengineering in World Health & Review for Final •Tuesday, April 17–No class! •Thursday, April 19–Exam 3, Lectures 16-23•Tuesday, April 24–Project Presentations•Final Exam (see syllabus for details)Reading Assignment for Thursday•Financial Anatomy of Biomedical Research, JAMA. 2005, Sep 21;294(11):1333-42•Application of Microchip Assay System for the Measurement of C-reactive Protein in Human Saliva, Lab Chip. 2005, 5, 261-269•An exam question will draw from these articlesAfter Today’s Lecture…•Appreciate why it costs so much in the US (time & money) to develop devices and get them to market•Speculate on what this means for developing countries that depend on 1st world research•Understand the importance and magnitude of research funded by the governmentNIBIB Grantsmanship ProgramU of H, Oct. 31, 2006Administration forChildren and Families(ACF)Administration forChildren and Families(ACF)Food and DrugAdministration(FDA)Food and DrugAdministration(FDA)Health Resourcesand ServicesAdministration(HRSA)Health Resourcesand ServicesAdministration(HRSA)TheSecretaryDeputy SecretaryTheSecretaryDeputy SecretaryAdministration onAging(AoA)Administration onAging(AoA)Centers for MedicareAnd Medicaid Services(CMS)Centers for MedicareAnd Medicaid Services(CMS)Indian HealthServices(IHS)Indian HealthServices(IHS)National Institutesof Health(NIH)National Institutesof Health(NIH)Centers for Disease Controland Prevention(CDC)Centers for Disease Controland Prevention(CDC)Substance Abuse andMental Health ServicesAdministration(SAMHSA)Substance Abuse andMental Health ServicesAdministration(SAMHSA)Program SupportCenter(PSC)Program SupportCenter(PSC)Agency for ToxicSubstances andDisease Registry(ATSDR)Agency for ToxicSubstances andDisease Registry(ATSDR)Agency for Healthcare Research and Quality(AHRQ)Agency for Healthcare Research and Quality(AHRQ)U. S. Department of Health & Human Serviceshttp://www.fda.gov/oc/orgcharts/fda.pdfWorkings of the FDA•Responsibility to protect the public and dealing with technological changes•Regulates anything for diagnosis, cure, mitigation, or prevention of disease as well as anything intended to affect structure/function of the human body •3 Branches–Drugs–Devices–Biologics–Combination products overseen by panel from three areas•Requires the expertise of many- Medical technologists - Statisticians - Consumer safety officers and field investigators - Human factors specialists- Engineers (including biomedical electrical, and materials)- Biologists and microbiologists- Physcians and other clinicians- Chemists, biochemists, and toxicologistsRole of Center for Devices and Radiological Health (CDRH)•Ensure that products coming to market have more benefit than risk•Ensure that products are labeled so that practitioners and patients know what to expect from their use•Regulates 1,700 types of devices•23,000 registered manufacturers•In 1996 received 20,236 device related submissionsRegulation of Medical Devices•FDA did not regulate devices before 1938•1938:–FDA could only challenge sale of products it believed were unsafe–Could only remove them from the market after patient injuries•1960s:–Rapid innovation in medical technology–Tried to regulate many as drugs, i.e. contact lenses, IUDs–Catastrophic failures of heart valves and pacemakers•1970s:–Broad recognition that different rules were needed to regulate devices–No single policy would work for all devices•Tongue depressor•Artificial heart•Review commission determined that more than 700 deaths and 10,000 injuries were associated with medical devicesMedical Device Act (1976)•Amendments to FD&C act allowed for classification of medical devices, device listing, establishment registration, adherence to Good Manufacturing Practices (GMP), and extensive control over market introduction of medical devices•Major amendments again in ’90, ’97, and ’02•However, CDRH can not specifically regulate biomaterials; biomaterials are indirectly regulated according to intended useClass Activity (~5 min)•Break up into groups of 3 students representing –Policy Maker–Manufacturer–Consumer•Discuss what you would want to see in a device approval process from each perspective•Report backBasic Regulatory Requirements•Premarket notification 510(k) or Premarket approval (PMA)•Establishment registration on form FDA-2891•Medical device listing on form FDA-2892•Quality system (QS) regulation•Labeling requirements•Medical device reporting (MDR)http://www.fda.gov/cdrh/devadvice/overview.htmlDevice Approval Process•Device + intended use considered together•Manufacturer submits request for marketing approval•Advisory panel–One consumer representative (non-voting)–One industry representative (non-voting)–Physicians and scientists•FDA not required to follow recommendations of panel, although they usually doSteps in Device Approval Process•Device, drug, biologic, combo?•If device, Class I, II, or III?•510(k) or PMA pathway?•If PMA passes, get IDE•2 phases of clinical trials•If efficacy shown, submit pre-market notification•Post-market surveillanceClasses of Devices according to CDRH •Class I–Pose least risk to patient–Not life
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