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The IDE process at Vanderbilt University

Barbara Gibson, MS, RN, CCRC, CIP, CHRC Regulatory Affairs Officer Vanderbilt Human Research Protection Program. The IDE process at Vanderbilt University. Goals. To facilitate understanding regarding Vanderbilt University ’ s new IDE process for compliance with FDA device regulation

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The IDE process at Vanderbilt University

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  1. Barbara Gibson, MS, RN, CCRC, CIP, CHRC Regulatory Affairs Officer Vanderbilt Human Research Protection Program The IDE process at Vanderbilt University

  2. Goals • To facilitate understanding regarding Vanderbilt University’s new IDE process for compliance with FDA device regulation • Foster open discussion regarding the IDE process

  3. Agenda • Brief History • Device defined • Process • Institutional policy • Center for Technology Transfer and Commercialization • Regulatory • Process summarized • Device Development Case Studies • Dr. Robert Labadie • Dr. Pierre D’Haese • Dr. Peter Konrad • Questions and Discussion

  4. Dalkon Shield • Caused pelvic inflammatory disease, infertility, spontaneous septic abortion • Resulted in 18 deaths and over 200,000 infections Source: www.amazon.com Source: www.docstoc.com Source: http://www.wired.com/magazine/2011/07/ff_iud/ Source: www.docstoc.com Source: oldnews.aadl.org

  5. Medical Device Amendments of 1976 • First law to give the FDA authority to review medical devices before entering the market • First IRB review of medical devices • Classified devices –risk based system (basis for regulatory control) Source: rx-wiki.org

  6. Device defined Per section 201(h) of the FD&C Act, a device is • "an instrument, apparatus, … contrivance, implant, in vitro reagent, or other similar or related article, including a component part, … • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, … or • intended to affect the structure or any function of the body…and which does not achieve any of it's primary intended purposes through chemical action …and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."

  7. Examples • Software, MMA, CDS • IVDs • Tissue engineered implants • BMP • Computer guided robotic surgery • Nanotechnology • Powered muscle stimulators • Diagnostic ultrasound systems • Combination products, i.e. Zecuity transdermal patch Source: mobihealthnews.com Source: http://www.mpo-mag.com/news/2013/03/07/new_app_gains_ce_mark_as_medical_device Source: www.nyheadache.com

  8. Faculty Manual Chapter 4: Policy on Technology… • “…governs the ownership, protection, and transfer of Technology (Inventions, Discoveries, and other Innovations) …created or authored by University faculty members, staff members, or students.” • “These research results include, for example, computer programs, integrated circuit designs, industrial designs, databases, technical drawings, biogenic materials, and other technical creations.”

  9. Role of CTTC • Design ready • IP? • Market? • Next steps • Commercialize • Further research/testing? • Don’t commercialize • Continue research?

  10. When is an IDE needed? • All device investigations are subject to the IDE regulation (SR and NSR) • Is safety and/or efficacy data being collected? • Intent to support a marketing application for a new intended use/new indication for use is not a consideration for needing an IDE if SI

  11. Relevant FDA regulations 21 CFR 50 Protection of Human Subjects and Informed Consent 21 CFR 54 Financial Disclosure 21 CFR 56 IRB 21 CFR 812 Investigational Device Exemption (IDE) – supports HDE, 510(k) or PMA 21 CFR 820 Quality System Regulation Source: www.pharmafile.com Source: www.nrepp.samhsa.gov

  12. Critical to start early based on needs • Decision to commit • Time • Money • Staff

  13. Increasing Need for Support

  14. Abbreviated IDE Requirements SR?

  15. Regulatory Assistance

  16. IDE Tools and Resources

  17. Case Studies • Dr. Robert Labadie • Dr. Pierre D’Haese • Dr. Peter Konrad

  18. For assistance with your device research… Contact Barbara Gibson Regulatory Affairs Officer, HRPP (615) 875-8965 Email: barbara.gibson@vanderbilt.edu

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