Barbara Gibson, MS, RN, CCRC, CIP, CHRCRegulatory Affairs OfficerVanderbilt Human Research Protection Program

Goals

To facilitate understanding regarding Vanderbilt University’s new IDE process for compliance with FDA device regulation

Foster open discussion regarding the IDE process

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

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

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

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."

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

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.”

Role of CTTC

Design ready IP? Market? Next steps

Commercialize Further research/testing?

Don’t commercialize Continue research?

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

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

Critical to start early based on needs Decision to commit

Time Money Staff

Increasing Need for Support

Abbreviated IDE

Requirements

SR?

Regulatory Assistance

IDE Tools and Resources

Case Studies

Dr. Robert Labadie

Dr. Pierre D’Haese

Dr. Peter Konrad

For assistance with your device research…

ContactBarbara GibsonRegulatory Affairs Officer, HRPP(615) 875-8965 Email: barbara.gibson@vanderbilt.edu