Understanding Expanded Access for Medical Devices

This webinar will provide a comprehensive understanding of the four main provisions by which FDA may make an unapproved medical device available for physicians/ patients. It will discuss the criteria and requirements to be fulfilled and what options to consider and when.

Why Should You Attend:

You should attend this webinar if you or your clinical investigators would want to know the answer to one or more of the following:

• Does your company clearly understand the risks associated with inappropriate expanded access use of your medical device?
• Do your research sites/clinical investigators understand the requirements for Emergency Use, Treatment Use, Compassionate Use and Continued Access?
• When is FDA Approval required?
• What are your obligations under these programs?
• What are the key considerations in determining which option is most viable?

Areas Covered in this Webinar:

• Brief overview of 510(k), PMA and IDE requirements.
• Emergency Use Criteria and Regulatory Obligations.
• Treatment Use Criteria and Regulatory Obligations.
• Compassionate Use Criteria and Regulatory Obligations.
• Continued Access and Regulatory Obligations.

Who Will Benefit:

• Clinical Investigators
• Regulatory Affairs Personnel
• R&D Managers
• Site Administrators
• Clinical Affairs Personnel
• Clinical Research Managers
• Clinical Project Managers