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BIOE 301

BIOE 301. Lecture Twenty-Two. Schedule. 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

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BIOE 301

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  1. BIOE 301 Lecture Twenty-Two

  2. Schedule • 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)

  3. 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 articles

  4. After 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 government

  5. The Secretary Deputy Secretary Administration for Children and Families (ACF) Administration on Aging (AoA) Food and Drug Administration (FDA) Health Resources and Services Administration (HRSA) Centers for Medicare And Medicaid Services (CMS) Agency for Healthcare Research and Quality (AHRQ) Indian Health Services (IHS) National Institutes of Health (NIH) Centers for Disease Control and Prevention (CDC) Agency for Toxic Substances and Disease Registry (ATSDR) Substance Abuse and Mental Health Services Administration (SAMHSA) Program Support Center (PSC) U. S. Department of Health & Human Services NIBIB Grantsmanship Program U of H, Oct. 31, 2006

  6. http://www.fda.gov/oc/orgcharts/fda.pdf

  7. Workings 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 • - Engineers (including biomedical • electrical, and materials) • Biologists and microbiologists • Physcians and other clinicians • Chemists, biochemists, and toxicologists • - Medical technologists • - Statisticians • Consumer safety officers and field • investigators • - Human factors specialists

  8. Role 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 submissions

  9. Regulation 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 devices

  10. Medical 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 use

  11. Class 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 back

  12. Basic 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.html

  13. Device 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 do

  14. Steps 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 surveillance

  15. Classes of Devices according to CDRH • Class I • Pose least risk to patient • Not life sustaining • GMP, proper record keeping required • 30% of devices • X-ray film, tongue depressors, stethoscopes • Class II • Not life sustaining, but must meet performance standards • Blood pressure monitors, Catheter guide wires • 60% of devices • Class III • Pose greatest risk to patient • For use in supporting or sustaining human life • 10% of devices • Stents, heart valves, LVADs • Require GMP, failure modes analysis, animal tests, human clinical studies under IDE

  16. Substantially equivalent to a legally marketed product Before May 28th, 1976 Determined by FDA Most Class I exempt, most Class II required For description of device classification and database access, visit http://www.fda.gov/cdrh/devadvice/313.html 3rd Party review process now available Most Class III required Requires submission of clinical data Actual approval process of device by FDA 510(k) vs PMA

  17. 510(k) Determination Flow Chart http://www.fda.gov/cdrh/ode/dd510kse.pdf

  18. Premarket Approval (PMA) • Device and company name • Indications • Device description and schematics • Description of alternate practices • Contraindications • Potential adverse affects • Summary of all pre-clinical studies

  19. Pre-clinical studies • Physical and chemical analysis • Biological testing • Pyrogenicity (LAL assay) • Blood compatibility • Acute/chronic toxicity • Mutagenicity • Validation of sterility • Animal studies • Inflammatory/immune response • Degradation • Particulate migration • Performance • How can one know how to perform all these tests? STANDARDS!

  20. Standards • Tripartite Agreement on Biocompatibility: FDA guidelines regarding techniques for pre-clinical testing • ASTM Committee F-04 on Medical and Surgical Materials and Devices • Standards for • Test methods: specimen prep, conditions, number of samples, data analysis • Materials: chemical and physical properties • Devices: schematics, dimensions, tolerances • Procedures: how to do something besides a test, i.e. sterilization, • FDA accepts standards such that one can write, “I did X according to Y standard” • Shift in perspective towards worldwide harmonized system • ISO 10993 document • At least 16 parts describing globally recognized standards for • Biocompatibility screens • Evaluation for ethylene oxide residues • Toxicity studies (i.e., cyto, systemic, & kinetics) • Many more

  21. IDE and Clinical Trials • Investigational Device Exemption • Enables experimental use of high risk device • Must have positive engineering and animal data • Clinical Trials • First give approval for feasibility studies with small number of patients • Then proceed to multi-center trials • Larger data sets frequently show results from small sample sets are not true

  22. Humanitarian Use Exemption • Device designed to treat or diagnose condition that affects <4,000 patients/year • Device would not otherwise be available without exemption • No comparable device is available • Patients will not be exposed to unreasonable or significant risk of injury or illness by device

  23. Medical Device Reporting • System to detect device related problems in a timely manner • Serious injuries or deaths that may have been caused by or related to a a medical device must be reported to the manufacturer of the device within 10 days • Must be reported to the FDA within 10 days

  24. Steps 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 surveillance

  25. Recently Approved Devices • http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/MDA/mda-list.cfm?list=1

  26. Device Development Costs $$$ • Who funds development? • What is the typical government grant process?

  27. R&D Funding for Biomedical Research • Federal government • Funds ~ 35% of all medical research in US • Mostly funded through NIH • Current NIH budget: ~$28 billion/year • NIH budget doubled from 1998-2003 • Last year 0% increase • Focus is on basic research

  28. NIH Congressional AppropriationsFY1997- FY2006 Dollars in billions NIBIB Grantsmanship Program U of H, Oct. 31, 2006

  29. Total Research Expenditures at Rice

  30. NIBIB The NIH Organization OD NIA NIAAA NIAID NIAMS NICHD NIDCD NIDCR NIDDK NIDA NIEHS NIGMS NIMH NINDS NINR NCI NEI NCCAM NCMHD NCRR NHGRI NHLBI NLM FIC CC CSR CIT NIBIB Grantsmanship Program U of H, Oct. 31, 2006

  31. NIH • National Cancer Institute • National Eye Institute • National Heart, Lung, and Blood Institute • National Human Genome Research Institute • National Institute on Aging • National Institute on Alcohol Abuse and Alcoholism • National Institute of Allergy and Infectious Diseases • National Institute of Arthritis and Musculoskeletal and Skin Diseases • National Institute of Biomedical Imaging and Bioengineering • National Institute of Child Health and Human Development • National Institute on Deafness and Other Communication Disorders • National Institute of Dental and Craniofacial Research • National Institute of Diabetes and Digestive and Kidney Diseases • National Institute on Drug Abuse • National Institute of Environmental Health Sciences • National Institute of General Medical Sciences • National Institute of Neurological Disorders and Stroke • National Institute of Nursing Research • National Library of Medicine

  32. The NIBIB Vision To profoundly change health care by pushing the frontiers of technology to make the possible a reality. NIBIB Grantsmanship Program U of H, Oct. 31, 2006

  33. A big challenge for the NIBIB is promoting multidisciplinary research • Clinicians, biologists and engineers speak in different languages • Clinicians and biologists may not know what is technically possible; engineers may not know the biomedical problems • Continued, ongoing collaboration essential NIBIB Grantsmanship Program U of H, Oct. 31, 2006

  34. Current NIBIB Grant Portfolio Areas • Imaging Agents & Molecular Probes • Image Displays • Image Guided Therapies & Interventions • Image Perception • Image Processing • Magnetic, Biomagnetic & Bioelectric Devices • Magnetic Resonance Imaging & Spectroscopy • Nuclear Medicine • Optical Imaging & Spectroscopy • Ultrasound and Acoustics • X ray, Electron & Ion Beam • Biosensors • Biomaterials • Biomechanics • Biomedical Informatics • Computational Biology • Drug & Gene Delivery Systems • Lab-on-a-Chip Devices/Microsystems • Medical Devices & Implant Science • Nanotechnology • Rehabilitation Engineering • Surgical Tools & Techniques • Telemedicine • Tissue Engineering NIBIB Grantsmanship Program U of H, Oct. 31, 2006

  35. NIH Granting Process Center for Scientific ReviewDivision of Receipt and Referral My Application xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx PI / Institution submits application Integrated Review Group (in CSR) or Review Office (in Awarding IC) Evaluates Scientific Merit Awarding Institute or Center Revision / Resubmission Evaluates Relevance Advisory Council Conduct Research $$$$$$ Recommends Action Allocates Funds Institute Director NIBIB Grantsmanship Program U of H, Oct. 31, 2006 http://www.csr.nih.gov/video/video.asp

  36. Scores and Funding Level • ~1/3 go unscored (triaged) • ~2/3 are scored • 100 best score • 500 worst score • Typically need score of 100-170 to be funded • Approximately 10-15% of submitted proposals are funded

  37. For More Information, See the Following Sources • http://www.fda.gov/cdrh/devadvice/overview.html • Biomaterials Science: An Introduction to Materials in Medicine, 2nd Ed. Chap 10. Elsevier Academic Press. Editors: Ratner, Hoffman, Schoen, Lemons. • Materials from NIBIB Grantsmanship Program,University of Houston, Oct. 31, 2006

  38. Index Cards • What was the muddiest point of this lecture? • What was the clearest point in this lecture? HHMI survey, see you on Thursday!

  39. Design Control Guidance http://www.fda.gov/cdrh/comp/designgd.html

  40. Rice Types of Universities • Carnegie Classification • Taxonomy of colleges and universities • Doctorate-Granting Institutions • Research Universities /Very High Research Activity • Research Universities/ High Research Activity • Doctoral/Research Universities • Master’s Colleges & Universities • Baccalaureate Colleges • http://www.carnegieclassification-preview.org/index.aspx

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