Medical Device Regulatory Affairs Program (MDRAP)

Mission

To support investigators who are involved with Food and Drug Administration (FDA) regulated device research at Vanderbilt University. MDRAP will accomplish this through the provision of:

  • the development of regulatory strategies
  • early regulatory product development guidance
  • assistance with Investigational Device Exemption (IDE) preparation and maintenance
  • education
  • information
  • collaboration

Vision

The services provided by MDRAP will contribute to the quality of device clinical research conducted under the aegis of Vanderbilt University and will help to ensure compliance with FDA regulations and institutional policies and procedures.


MDRAP Services

Now Offered:

  • Individualized consultation
  • Early product development regulatory guidance
  • Determination of need for IDE
  • FDA pre-submission meeting guidance and support
  • Liaise with the FDA
  • Assistance with IDE submission assembly and review (click to view)
  • Assistance with IRB device documentation
  • Education and training in Sponsor-Investigator responsibilities for FDA regulated device research
  • Assistance with maintenance and ongoing reporting post-IDE approval
  • Provision and maintenance of Sponsor-Investigator IDE Handbook
  • Provision of IDE templates and tools
  • Review of grant, contract and CTTC device submissions for potential regulatory needs
  • Assistance with identification of appropriate resources relative to device research
  • Facilitation of collaborative activities across the institution to facilitate quality device research and regulatory compliance

Coming Soon:

  • Development of regulatory strategy
  • FDA design control guidance
  • GLP Training
  • Design control training and support
  • Vendor qualification
  • Maintenance of IDE database
  • First and second party audits

*MDRAP does not provide regulatory advice to companies, including those that have licensed Vanderbilt University technologies.


 

Staff

Kenneth Holroyd, M.D., MBA
MEDICAL DIRECTOR
615.343.8817   •   kenneth.holroyd@vanderbilt.edu

 

Lu Ellen Davie, MS, RN, CIP
QUALITY ASSURANCE MANAGER
615.343.7872   •   lu.davie@vanderbilt.edu

 

 

 

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