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?
The FDA allows access to investigational devices under one of four main mechanisms by which the agency may make an unapproved device available. But there are criteria that must be met and requirements that must be fulfilled dependent upon the marketing status of the device and the timing of the need.
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:
Regulatory Affairs Personnel
Clinical Affairs Personnel
Clinical Research Managers
Clinical Project Managers
Added by complianceonlinecom on November 7, 2012