20 May BBA Regulatory Expert to Present on FDA EFS Program at Medical Device Summit
Marlborough, MA… May 20, 2015
Marybeth Gamber, Senior Regulatory Affairs Principal in Consulting Services will be speaking at the Opal Events Medical Devices Summit West on June 25 and 26, 2015 in San Jose, CA. The presentation entitled, “Early Feasibility Medical Device Clinical Studies,” will focus on the FDA Early Feasibility Study (EFS) program. The intention of the EFS program is for devices that are early in their development lifecycle for which preclinical test methods are either not available or adequate to provide information to advance the device development process. Ms. Gamber will discuss the background of the IDE process, the creation of the EFS program and guidance, along with the key steps and considerations to consider when pursuing this path. In addition lessons learned from on early case-studies will be discussed.
For more on this event please visit http://www.opalevents.org. If you attend, stop by the BBA booth and learn more about how BBA can propel your company forward.