1. Barbara Gibson, MS, RN, CCRC, CIP, CHRC Regulatory Affairs Officer Vanderbilt Human Research Protection Program

2. Goals To facilitate understanding regarding Vanderbilt Universitys 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 DHaese 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: http://www.wired.com/magazine/2011/07/ff_iud/ Source: www.docstoc.com Source: oldnews.aadl.org Source: www.docstoc.com Source: www.amazon.com

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 : www.nyheadache.com Source: mobihealthnews.com Source: http://www.mpo- mag.com/news/2013/03/07/new_app_gains_ce_m ark_as_medical_device

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

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

13. Increasing Need for Support

14. IRBQSR Novel (Investigational device) Legally marketed off label w mods (Investigational device) FDA IDE? Legally marketed off label (Investigational use) Abbreviated IDE Requirements SR?

15. Regulatory Assistance Pre-Approval Determination of need for IDE from FDA Assistance with QSR resources (to be developed) Templates Pre-sub meeting guidance Liaison with FDA Assistance with submission assembly and review Assistance with IRB device documentation Post-Approval Training in Sponsor-investigator responsibilities (NSR and SR) (under development) Templates Assistance with supplement/reports assembly and review Reporting milestone reminders (to be developed) Quality assurance (to be developed)

16. IDE Tools and Resources

19. Case Studies Dr. Robert Labadie Dr. Pierre DHaese Dr. Peter Konrad

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