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21 U.S. Code § 360e-3. Breakthrough devices
(a) Purpose
The purpose of this section is to encourage the Secretary, and provide the Secretary with sufficient authority, to apply efficient and flexible approaches to expedite the development of, and prioritize the Food and Drug Administration’s review of, devices that represent breakthrough technologies.
(b) Establishment of programThe Secretary shall establish a program to expedite the development of, and provide for the priority review for, devices, as determined by the Secretary—
(1)
that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions; and
(2)
(A)
that represent breakthrough technologies;
(B)
for which no approved or cleared alternatives exist;
(C)
that offer significant advantages over existing approved or cleared alternatives, including the potential, compared to existing approved alternatives, to reduce or eliminate the need for hospitalization, improve patient quality of life, facilitate patients’ ability to manage their own care (such as through self-directed personal assistance), or establish long-term clinical efficiencies; or
(D)
the availability of which is in the best interest of patients.