Table 3.

Special programs to promote medical device innovation at Center for Devices and Radiological Health.

Early Feasibility Study Program	Facilitates conduct of early feasibility studies in the United States
Breakthrough Devices Programa	Eligible devices required to meet two criteria:
	Provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating disease or condition
	The device also meets at least 1 of the following:
	Represent breakthrough technology
	No approved or cleared alternatives exist
	Offers significant advantages over existing approved or cleared alternatives
	Device availability is in the best interest of patients

^aFor sponsors of devices subject to premarket approval applications (PMAs), premarket notification (510(k)) or requests for De Novo designation.