Clinquest COO and Vice President of Clinical and Regulatory John McLane, Ph. D. will be speaking at the Medical Device and Diagnostics Summit on Regulatory Approvals on September 27 in Boston, MA. He will be speaking on the topic of IDE preparation.
When Do You Start Preparing for Your IDE?
Many Class II and most Class III devices under the pathway the FDA is taking may require clinical testing during the development process. One common regulatory pathway is to apply for an Investigational Device Exemption (IDE). The IDE process takes good planning and communication from the beginning with an understanding of what is needed in the application. A well planned and well executed IDE can help tremendously in the PMA or Premarket Notification 510K applications.
Define significant and non significant risk devices
Key parts of the IDE
FDA and IRB communications
Execution of the IDE study
To register for the Medical Device and Diagnostics Summit on Regulatory Approvals, call toll free 800-817-8601 or visit http://www.cbinet.com/regapproval.
View brochure for complete conference details.