10-Week In Vitro Diagnostic Devices Fundamentals: Study Design, Conduct, Regulatory Requirements and Submissions for Approval

Course Description

The online 10-Week In Vitro Diagnostic Devices Fundamentals program covers the different regulatory pathways for medical devices, and how each impact the regulations to which they are subjected. Specifically, we will focus on in vitro diagnostic devices (IVDs), and discuss how the determination is made for those to be exempt from most of the requirements of the Investigational Device Exemption (IDE) regulations. We will also discuss how the determination of significant and non-significant risk for the device is made, and how it affects the submissions and review process by the IRB. Study design and conduct basic considerations, and quality control (QC) requirements for IVDs and laboratory-developed tests will be covered.

Prior to the start of the course, participants will receive their login credentials and links to access and download the many class resources and class meeting links. Upon course completion, participants will be provided training certificates. In order to receive accreditation CEUs, participants are required to pass both a mid-term and final exam. Upon completion of the exams, CEU certificates will be provided.

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
• Understand considerations required for laboratory-developed tests
• Learn what documentation to submit to the IRB, depending upon the device category
• 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

Course Outline

• Module 1:A Brief Overview of the Device Development Process
• Module 2: Investigational Device Exemptions (IDEs) and Types of IDEs
• Module 3: Regulatory Requirements for Planning, Initiating and Executing a Clinical Trial for Medical Devices
• Module 4: Transition From Pre-Clinical Phase of Development to Clinical Phases; Feasibility and Pivotal Study Requirements and Basic Considerations for Study Design and Conduct ; IDE Exempt Studies; Documentation Required for IRB Submissions
• Module 5: Sponsor Responsibilities for Significant and Non-Significant Risk Devices
• Module 6: Classification of In Vitro Diagnostic Products (IVDs); Regulatory Requirements for IVDs; Review of Pre-Submission Process for IVDs
• Module 7: Investigational IVDs Used in Clinical Investigations of Therapeutic Products; the Difference Between IVDs and Companion Diagnostic Trials and Classifications; Overview of IVD Study Designs with Predictive and Prognostic Biomarkers
• Module 8: Emergency Use of IVDs Outside of Study Protocol; De Novo Classification for IVD Devices;, Labelling and Pre-Market Approval Requirements for IVDs
• Module 9: FDA Requirements for Quality Control (QC) for Medical Devices and IVDs; Laboratory- Developed Tests and Applicable FDA Regulations; Current Good Manufacturing Practices (CGMPs) and Quality System Regulation (QSR Regulation) Requirements for Medical Devices; CLIA-Waiver Requirements
• Module 10: Medical Device Reporting Requirements

Who Should Attend

• 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

NOTE: This course is for individual registrants only and does not allow for group training.

What participants say about Barnett's 10-Week courses ...

“Great course! Instruction is expertly led and engaging. I will recommend Barnett to any colleague and will seek out topics for my own future training and professional development needs.”

"The course has been so incredibly helpful thus far...I look forward to Thursday evenings!"

“This class exceeded my expectations of an online learning experience. The instructor was knowledgeable, came equipped with great examples to keep the class interesting and is a strong presenter. Thank you!”

Instructor

Marina Malikova, Ph.D., MSci, MA, CCRA., RAC

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Course Length and Time

10 weeks for 3 hours each week.

Registration Fees

$1,795 by Early Bird Deadline  

$1,995 after Early Bird Deadline

This course is for individual registrants only and does not allow for group training.

All participants are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met.

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 30 hours (3.0 CEUs) of continuing education credit for full participation, including the completion of a mid-term exam, final exam, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-23-043-L99-P. Released: 9/23.   

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