Key benefit and risk factors to be considered while submitting an investigational device exemption (IDE) to FDA will be discussed in this webinar. IDE submission allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to FDA.
FDA recent guidance explains how the agency evaluates benefit and risk issues in Investigational Device Exemptions (IDE) for medical devices that require clinical trials in order to be registered. The recommendations included in this FDA Guidance document for benefit and risk information will be discussed so IDE applicants can have a clear idea on what is expected by the FDA for their review and approval of the IDE.
Learning Objectives:
- Background Information on IDE
- Devices that can fall under this exemption category
- Basic clinical study requirements
- Understanding the FDA Guidance document
- Device classifications and applicability of 510K vs. PMA
- Understanding the associated regulatory benefit risk factors
Why Should You Attend:
You will understand the IDE approval process by the Agency so the industry Sponsors can lay the path for:
a) Successful evaluation of the investigational device's safety and effectiveness for the purpose of the required data collection from clinical studies
b) Support the new indication and device labelling for Premarket Approval (PMA) Application for Class III devices and safety data to support 510K submissions for Class II devices
c) This 'Investigational use' can also include a clinical evaluation of certain device modifications or new intended uses of legally marketed devices. This webinar will address those relevant IDE sections from an industry perspective to achieve a regulatory review with the goal of an "approved IDE" to commence a Feasibility Study or Pivotal Multicenter Clinical Trial. The speaker will also discuss how the agency evaluates benefit and risk issues in Investigational Device Exemptions (IDE) for medical devices that require clinical trials in order to be registered
Areas Covered
- Clear understanding of appropriate and expected regulatory strategies and guidelines for your IDE
- Understand the FDA application process and administrative action with your IDE
- Pre IDE meetings and understanding the responsibilities of the sponsor
- Current IDE requirements per 21 CFR 812 including procedures involved with the clinical studies and expectations
- Highlights and Scope of the FDA Guidance document
- Overview of selected Benefit-Risk (B-R) Guidance Sections
- Assessing Benefits and Risks For IDE Applications - Risk
- Characterization and Risk Management
- Regulatory Standards and Subject Protections For IDE's
- Live Q&A
Instructor
Ms. Meena Chettiar has a very strong background in Quality in the FDA regulated industries. Ms. Chettiar received her M.S. in Regulatory Affairs for Medical Devices in Minnesota, USA, and M.A. SC in Chemical engineering from University of British Columbia in Canada and her B.S. and M.S in Applied Chemistry from the University of Madras, India. Ms. Chettiar is also very knowledgeable in Clinical Research auditing for medical devices and pharmaceutical products.
Meena is currently working as a Senior Associate at NAMSA and is the Founder and Principle Consultant of MNQ Consulting Services LLC. Meena has worked as Quality and Regulatory Manager at ProMed Pharma, Medical and combination device manufacturer, a Senior Supplier Quality Engineer for Covidien with drug coated balloons and guide wires, for Baxter Bio Surgery, as a Senior Quality Manager at Teva Pharmaceuticals for over 10 years and as QC lab supervisor at Land O' Lakes.
Meena has also worked for Agriculture and Health Canada in several technical capacities for about 10 years. Meena has performed mock QSIT Audits and has responded to several FDA 483s.
Meena has played a key role in quality system implementations in the food, pharmaceutical, and medical device industries. Meena has participated as the lead supplier/internal/GMP auditor in several compliance audits in the US, Canada, Puerto Rico and Costa Rica.
Meena is the Chair elect for MNASQ (American Society for Quality) this year. Meena is ASQ certified CQA (Certified Quality Auditor), CBA (Certified Biomedical Auditor), CQIA (Certified Quality Improvement Associate), and CMQ/OE (Certified Manager of Quality/Organizational Excellence).
Meena has served as an instructor for these ASQ certification classes since 2006. She is a certified instructor for ASQ learning institute for CBA and an adjunct instructor for Medical Technology Quality graduate program for St. Cloud State University in Minnesota. Meena is a coauthor of the CBA (Certified Biomedical Auditor) Primer for the Quality Council of Indiana and is very passionate about Installation and growth of Quality Systems in general.