{"product_id":"10-week-in-vitro-diagnostic-devices-fundamentals-study-design-conduct-regulatory-requirements-and-submissions-for-approval-2026-09-22","title":"10-Week In Vitro Diagnostic Devices Fundamentals: Study Design, Conduct, Regulatory Requirements and Submissions for Approval","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThe 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.\u003c\/p\u003e\u003cp\u003ePrior 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.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eDiscuss the FDA's role in device development\u003c\/li\u003e \u003cli\u003eExplain the logistics of the device development process\u003c\/li\u003e \u003cli\u003eUnderstand regulatory pathways for devices, specifically in vitro diagnostic tests\u003c\/li\u003e \u003cli\u003eReview the pre-submission process for IVDs\u003c\/li\u003e \u003cli\u003eUnderstand considerations required for laboratory-developed tests\u003c\/li\u003e \u003cli\u003eLearn what documentation to submit to the IRB, depending upon the device category\u003c\/li\u003e \u003cli\u003eIdentify scientific and practical issues associated with the planning of a clinical research study for medical devices\u003c\/li\u003e \u003cli\u003eExplain the post-approval responsibilities of sponsors and device reporting requirements\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eCourse Outline\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eModule 1:A Brief Overview of the Device Development Process\u003c\/li\u003e \u003cli\u003eModule 2: Investigational Device Exemptions (IDEs) and Types of IDEs\u003c\/li\u003e \u003cli\u003eModule 3: Regulatory Requirements for Planning, Initiating and Executing a Clinical Trial for Medical Devices\u003c\/li\u003e \u003cli\u003eModule 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\u003c\/li\u003e \u003cli\u003eModule 5: Sponsor Responsibilities for Significant and Non-Significant Risk Devices\u003c\/li\u003e \u003cli\u003eModule 6: Classification of In Vitro Diagnostic Products (IVDs); Regulatory Requirements for IVDs; Review of Pre-Submission Process for IVDs\u003c\/li\u003e \u003cli\u003eModule 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\u003c\/li\u003e \u003cli\u003eModule 8: Emergency Use of IVDs Outside of Study Protocol; De Novo Classification for IVD Devices;, Labelling and Pre-Market Approval Requirements for IVDs\u003c\/li\u003e \u003cli\u003eModule 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\u003c\/li\u003e \u003cli\u003eModule 10: Medical Device Reporting Requirements\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eNew Clinical, Regulatory, and Department Staff who will design clinical trial programs for medical devices\u003c\/li\u003e \u003cli\u003eProject Team Leaders with limited direct clinical trial experience who will be managing device development programs and supervising project managers\u003c\/li\u003e \u003cli\u003eMedical Directors involved in the development and conduct of device research\u003c\/li\u003e \u003cli\u003eMedical Writers involved in device trials\u003c\/li\u003e \u003cli\u003eClinical Research Associates working with organizations that sponsor device research\u003c\/li\u003e \u003cli\u003eRegulatory Affairs Professionals involved in research with IVDs\u003c\/li\u003e \u003cli\u003eResearch professionals involved in submitting material for IRB review\u003c\/li\u003e \u003cli\u003eIRB members and support staff involved in review of device research\u003c\/li\u003e \u003c\/ul\u003e\u003cp\u003eNOTE: This course is for individual registrants only and does not allow for group training.\u003c\/p\u003e\u003cp class=\"abstract\"\u003e\u003cspan class=\"bold\"\u003eWhat participants say about Barnett's 10-Week courses ...\u003c\/span\u003e\u003c\/p\u003e\u003cp\u003e\"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.\"\u003c\/p\u003e\u003cp\u003e\"The course has been so incredibly helpful thus far...I look forward to Thursday evenings!\"\u003c\/p\u003e\u003cp\u003e\"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!\"\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp\u003eMarina Malikova, Ph.D., MSci, MA, CCRA., RAC\u003c\/p\u003e\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003ca href=\"https:\/\/www.barnettinternational.com\/instructor-biographies\/\" title=\"Click here for complete trainer biographies\"\u003eClick here for complete trainer biographies\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003e\u003cspan class=\"purple-link\"\u003e\u003cb\u003e\u003ci\u003eCourse Length and Time\u003c\/i\u003e\u003c\/b\u003e\u003c\/span\u003e\u003c\/p\u003e\u003cp\u003e10 weeks for 3 hours each week.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003e$1,795 by Early Bird Deadline \u003c\/p\u003e\u003cp\u003e$1,995 after Early Bird Deadline\u003c\/p\u003e\u003cp\u003eThis course is for individual registrants only and does not allow for group training.\u003c\/p\u003e\u003cp\u003eAll participants are eligible for \"Certificates of Attendance,\" and accreditation, provided that accreditation requirements are met.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eAccreditation Information\u003c\/p\u003e\u003cp\u003eBarnett 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. \u003c\/p\u003e\u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003eHold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.\u003c\/span\u003e\u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53375372198253,"sku":"BI17440","price":1995.0,"currency_code":"USD","in_stock":true},{"title":"Academic","offer_id":53375372231021,"sku":"BI17440-ACADEMIC","price":1795.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/10-week-in-vitro-diagnostic-devices-fundamentals-study-design-conduct-regulatory-requirements-and-submissions-for-approval-2026-09-22","provider":"Barnett International ","version":"1.0","type":"link"}