In Vitro Diagnostic Devices: Study Design, Conduct, Regulatory Requirements and Submissions for Approval

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Course Description

This course reviews the different regulatory pathways for medical devices, including the determination of significant and non-significant risks and how it affects submissions and the review process. A specific focus on in vitro diagnostic devices (IVDs) will be taken as participants learn how the determination is made for the exemption of requirements of the Investigational Device Exemption (IDE) regulations. Study design conduct and Quality Control (QC) requirements for IVDs and laboratory developed tests will be discussed.

Learning Objectives

  • Discuss the FDA's role in device development
  • Explain the logistics of the device development process
  • Understand regulatory pathways for devices, specifically in vitro diagnostic tests
  • Review the "pre-submission" process for IVDs
  • Identify scientific and practical issues associated with the planning of a clinical research study for medical devices
  • Explain the post approval responsibilities of sponsors and device reporting requirements

Who Should Attend

  • New Project Managers
  • Project Managers with little or no device development or clinical trial experience
  • New Clinical, Regulatory, and Department Staff who will design clinical trial programs for medical devices
  • Project Team Leaders with limited direct clinical trial experience who will be managing device development programs and supervising project managers
  • Medical Directors involved in the development and conduct of device research
  • Medical Writers involved in device trials
  • Clinical Research Associates working with organizations that sponsor device research
  • Regulatory Affairs Professionals involved in research with IVDs
  • Research professionals involved in submitting material for IRB review
  • IRB members and support staff involved in review of device research



The course will be led by one of the following instructors:

Marina Malikova, Ph.D., MSci, M.A., C.C.R.A., RAC

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Course Outline

Day One: 8:30 a.m. - 5:00 p.m.

  • Module 1: Review of the device development process and regulatory requirements for devices
  • Module 2: Overview of regulatory requirements to plan, initiate and execute a clinical trial for medical devices; Investigational Device Exemptions (IDEs) and types of IDEs; IDE-exempt studies     
  • Module 3: Transition from pre-clinical phase of drug development to clinical phases, including feasibility and Pivotal study requirements; sponsor’s responsibilities for significant and non-significant risk devices
  • Module 4: Review the "pre-submission" process for IVDs; documentation required for IRB submissions
  • Module 5: Classification of in vitro diagnostic products (IVDs) and regulatory requirements for IVDs
  • Module 6: Investigational IVDs used in clinical investigations of therapeutic products, including differences between IVDs and companion diagnostic trials and classifications


Day Two: 8:30 a.m. - 5:00 p.m.     

  • Module 7: Emergency use of IVDs outside of study protocol     
  • Module 8: De Novo classification for IVD devices
  • Module 9: Labelling and pre-market approval requirements for IVDs     
  • Module 10: Laboratory developed tests and applicable FDA regulations
  • Module 11: FDA requirements for Quality Control (QC) and safety reporting for medical devices and IVDs
  • Module 12: Current Good Manufacturing Practices (CGMPs) and Quality System Regulation (QSR) requirements for medical device


Interactive Activities

  • Review a medical device application. Create a checklist that encompass timelines and sections needed from dif-ferent parties involved.

Registration Fees

Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.

Special rates are available for multiple attendees from the same organization.  Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.     

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Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-19-050-L01-P. Released: 10/19.

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.