barbara gibson, ms, rn, ccrc, cip, chrc regulatory affairs officer vanderbilt human research...
TRANSCRIPT
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Barbara Gibson, MS, RN, CCRC, CIP, CHRCRegulatory Affairs OfficerVanderbilt Human Research Protection Program
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Goals
To facilitate understanding regarding Vanderbilt University’s new IDE process for compliance with FDA device regulation
Foster open discussion regarding the IDE process
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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
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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
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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
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Device definedPer 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."
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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 patchSource: www.nyheadache.com
Source: mobihealthnews.com
Source: http://www.mpo-mag.com/news/2013/03/07/new_app_gains_ce_mark_as_medical_device
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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.”
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Role of CTTC
Design ready IP? Market? Next steps
Commercialize Further research/testing?
Don’t commercialize Continue research?
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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
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Relevant FDA regulations21 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
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Critical to start early based on needs Decision to commit
Time Money Staff
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Increasing Need for Support
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Abbreviated IDE
Requirements
SR?
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Regulatory Assistance
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IDE Tools and Resources
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Case Studies
Dr. Robert Labadie
Dr. Pierre D’Haese
Dr. Peter Konrad
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For assistance with your device research…
ContactBarbara GibsonRegulatory Affairs Officer, HRPP(615) 875-8965 Email: [email protected]