In-vitro Diagnostics (IVD) products provide critical information on patient’s health condition, based on which the healthcare provider develops and administers treatment plan. Although IVDs are medical devices, they are regulated under a separate set of regulations in U.S., Europe, and Canada.
This 2 day interactive course on in-vitro diagnostics is structured to understand the different set of IVD regulations, how to navigate through this maze of IVD regulations, and to win regulatory approvals. This In-vitro Diagnostics (IVD ) course will make the attendees understand the IVD regulations and develop regulatory strategies that secure regulatory approvals.
Learning Objectives:
After completion of this two day interactive course on IVD, the attendee will be able to:
- Understand why IVD is regulated differently.
- An overview of IVD Regulations - U.S. FDA., Europe (MDD), Canada.
- Develop Regulatory Strategies and determine Regulatory Pathways.
- Inclusion and exclusion of data and information for different submission.
- Format and Content of premarket submissions.
- Product Label and Labeling for IVDs.
- Working and interacting with the reviewers and regulators.
- Tips and Suggestions to secure rapid regulatory approvals.
Agenda
DAY 01 (11:00 AM - 6:00 PM EST)UNITED STATES
Session 1
- Evolving technologies and challenges of In-vitro Diagnostics (IVD) products
- Why the regulators need separate regulations even IVD is considered a device?
- Know the process and players at OIR (aka OIVD) of CDRH and Health Canada
Session 2:
Overview of US-FDA Regulations for IVDs
Lunch Break:
Session 3:
- Determination of classification & Identification of Predicate Device(s)
- Development of Regulatory Strategies and Pathways for IVDs
- Special consideration of IVD labeling requirements
Session 4:
- Determine the type of the required pre-market submission for your IVD
- Format and Content of 510(k), Pre-IDE, IDE and PMA
- What is a Clinical Laboratory Improvement Amendment (CLIA) of 1988?
- Preparation and submission for CLIA Waiver Application
EUROPE
Session 5:
- Overview of European IVD Regulations
- Understanding of EU MDD 98/79/EC for IVD and applicable MEDDEV documents
Session 6:
- Special consideration to Classification Rules for IVDs
- Conformity Assessment for CE Marking
- Special Labeling and electronic Labeling Requirements for IVDs
- Preparation of Technical File or Design Dossier
CANADA
Session 7:
- Overview of Canadian Medical Device Regulations (CMDR) for IVDs
- Understanding similarities and differences between U.S. and Europe regulations
Session 8:
- Format and Content of Canadian Medical Device License (MDL) Application
- Inclusion of the required data and information for MDL application
- Conclusion & Summary of the course
Course Provider
Haja Sittana El Mubarak,
Biologics consulting IncDr. El Mubarak is a Senior IVD consultant at Biologics consulting Inc. She has over 12 years of FDA experience spent primarily in the Center of Devices and Radiological Health (CDRH). Haja served for five years as the agency subject matter expert in Serological and Molecular Diagnostics of Viral Infections, representing the agency in providing consults, outreach and training to national and international stakeholders. Dr. El Mubarak has extensive experience in pre and post market regulation of in vitro diagnostic devices (IVDs) and is an expert in working with a variety of submission types including; 510(k)s, PMAs, IDEs, de novos, pre- submissions, 513 (g)s, and post-market submission.
Dr. El Mubarak has extensive knowledge of FDA regulations and policies, solving complex regulatory policy issues and communicating regulatory policies to internal and external stakeholders. She has an established record in developing regulatory guidance, Agency reports, internal policies, GHTF documents and CLSI documents.
Dr. El Mubarak has over 20 years of technical experience, in diagnostic virology, molecular biology, serology and IVD device development in clinical laboratory, academic research and regulation. She is an talented communicator, experienced in problem solving, stakeholder engagement and negotiation. She has taken multiple leadership roles in the agency in the areas of strategic planning, change management, training, outreach and championing diversity in workplace.
Who Should Attend
This interactive course is specifically developed for individuals, who are responsible for the design, development, manufacturing, marketing, and distribution of IVD products. This course is highly recommended for personnel involved in any of the following functions:
- Department Managers (middle management)
- Research & Development (R&D)
- Product Design & Development
- Validation Engineering
- Regulatory Affairs
- Quality Assurance
- Quality Control
- Manufacturing/Production
