FDA Medical Device Approval Process (510(k), IDE, PMA) 2013

The FDA Medical Device Approval Process is a course dedicated to FDA Medical Device Approval Process including:

• Submission preparation and the underlying scientific
• FDA device approval process
• The structuring and assembly of 510(k)s
• Regulatory principles involved
• Amendments and supplements thereto
• IDEs and PMAs
• Post-approval documents

Who should Attend

Attendees responsible for::

• Research
• Regulatory
• Legal
• Clinical
• Quality
• Manufacturing