Learn the appropriate and expected regulatory strategies and guidelines for your IDE.
An investigational device exemption (IDE) 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. Clinical studies are most often conducted to support a PMA. Only a small percentage of 510(k)’s require clinical data to support the application. Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated. An approved IDE permits a device to be shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of the Food, Drug, and Cosmetic Act (Act) that would apply to devices in commercial distribution. Sponsors need not submit a PMA or Premarket Notification 510(k), register their establishment, or list the device while the device is under investigation. Sponsors of IDE's are also exempt from the Quality System (QS) Regulation except for the requirements for design control.
Areas Covered in the seminar:
- Learn the appropriate and expected regulatory strategies and guidelines for your IDE.
- Application and administrative action with the IDE.
- Know the responsibilities of the sponsor.
- IRB review and approval and expectations.
- What records and reports are expected and required.
- IDE refers to the regulations under 21 CFR 812.
- Know the procedures involved with the clinical studies and expectations.
- Understand that if the study involves a significant risk device, the IDE must also be approved by FDA.
Who will benefit:
This webinar will provide valuable assistance and guidance to medical device firms that are currently preparing or will prepare for IDE submissions. The employees who will benefit include:
- All levels of Management for all departments
- QA/QC
- Regulatory Affairs and Compliance
- Engineering/Technical Services/Validation
- Consultants
- Operations and Manufacturing
Instructor Profile:
David R. Dills, Senior Consultant with PAREXEL Consulting has more than 19 years of hands-on and direct experience in quality, quality systems, regulatory affairs, compliance and validation within the life sciences and FDA regulated industry for all stages of product commercialization and FDA compliance. David has been previously affiliated with well-known manufacturers and service providers and has served in various quality, regulatory and compliance management and advisory capacities. David is global industry speaker and author of technical and compliance related topics published in industry journals. Please refer to his biography provided herein for additional information about his background and areas of expertise.
