Managing the IDE (Investigational Device Exemption) Submission for Compliance Success

Overview:

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 session:

• Learn the appropriate and expected regulatory strategies and guidelines for your IDE
• Understand the application process and administrative action with your 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 and departmental representatives and those who desire a better understanding or a "refresh" overview of the IDE preparation and submission process, including:

• Regulatory Affairs
• Clinical Affairs
• Quality and Compliance
• Marketing & Sales 
• Distributors/Authorized Representatives
• Engineering/Technical Services/Operations
• Consultants

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