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Who should attend Benefit and Risk Factors to be considered for managing the FDA IDE (Investigational Device Exemption) Submission for Medical Devices
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 medical device companies including management and departmental representatives and those who desire a better understanding
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Benefit and Risk Factors to be considered for managing the FDA IDE (Investigational Device Exemption) Submission for Medical Devices  

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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 medical device companies including management and departmental representatives and those who desire a better understanding

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Seminar Summary:

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. (see full course description)

 
 

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Training Course Syllabus:


Objectives of the Presentation


  • 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


Seminar Summary:

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. (see full course description)

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