(2) by inserting after section 515A (21 U.S.C. 
360e–1) the following: 
‘‘SEC. 515B. PRIORITY REVIEW FOR BREAKTHROUGH DE-
VICES. 
‘‘(a) IN GENERAL.—In order to provide for more ef-
fective treatment or diagnosis of life-threatening or irre-
versibly debilitating human diseases or conditions, the 
Secretary shall establish a program to provide priority re-
view for devices— 
‘‘(1) representing breakthrough technologies; 
‘‘(2) for which no approved alternatives exist; 
‘‘(3) offering significant advantages over exist-
ing approved or cleared alternatives, including the 
potential to, compared to existing approved or 
cleared alternatives, reduce or eliminate the need for 
hospitalization, improve patient quality of life, facili-
tate patients’ ability to manage their own care (such 
as through self-directed personal assistance), or es-
tablish long-term clinical efficiencies; or 
‘‘(4) the availability of which is in the best in-
terest of patients. 
‘‘(b) REQUEST FOR DESIGNATION.—A sponsor of a 
device may request that the Secretary designate the device 
for priority review under this section. Any such request 
for designation may be made at any time prior to the sub-
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mission of an application under section 515(c), a petition 
for classification under section 513(f)(2), or a notification 
under section 510(k). 
‘‘(c) DESIGNATION PROCESS.— 
‘‘(1) IN GENERAL.—Not later than 60 calendar 
days after the receipt of a request under subsection 
(b), the Secretary shall determine whether the device 
that is the subject of the request meets the criteria 
described in subsection (a). If the Secretary deter-
mines that the device meets the criteria, the Sec-
retary shall designate the device for priority review. 
‘‘(2) REVIEW.—Review of a request under sub-
section (b) shall be undertaken by a team that is 
composed of experienced staff and managers of the 
Food and Drug Administration and is chaired by a 
senior manager. 
‘‘(3) DESIGNATION DETERMINATION.—A deter-
mination approving or denying a request under sub-
section (b) shall be considered a significant decision 
under section 517A and the Secretary shall provide 
a written, substantive summary of the basis for the 
determination in accordance with section 517A(a). 
‘‘(4) RECONSIDERATION.— 
‘‘(A) REQUEST FOR RECONSIDERATION.— 
Any person whose request under subsection (b) 
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is denied may, within 30 days of the denial, re-
quest reconsideration of the denial in accord-
ance with section 517A(b)— 
‘‘(i) based upon the submission of 
documents by such person; or 
‘‘(ii) based upon such documents and 
a meeting or teleconference. 
‘‘(B) RESPONSE.—Reconsideration of a 
designation determination under this paragraph 
shall be conducted in accordance with section 
517A(b). 
‘‘(5) WITHDRAWAL.—If the Secretary approves 
a priority review designation for a device under this 
section, the Secretary may not withdraw the des-
ignation based on the fact that the criteria specified 
in subsection (a) are no longer met because of the 
subsequent clearance or approval of another device 
that was designated under— 
‘‘(A) this section; or 
‘‘(B) section 515(d)(5) (as in effect imme-
diately prior to the enactment of the 21st Cen-
tury Cures Act). 
‘‘(d) PRIORITY REVIEW.— 
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‘‘(1) ACTIONS.—For purposes of expediting the 
development and review of devices designated under 
subsection (c), the Secretary shall— 
‘‘(A) assign a team of staff, including a 
team leader with appropriate subject matter ex-
pertise and experience, for each device for 
which a request is submitted under subsection 
(b); 
‘‘(B) provide for oversight of the team by 
senior agency personnel to facilitate the effi-
cient development of the device and the efficient 
review of any submission described in sub-
section (b) for the device; 
‘‘(C) adopt an efficient process for timely 
dispute resolution; 
‘‘(D) provide for interactive communication 
with the sponsor of the device during the review 
process; 
‘‘(E) expedite the Secretary’s review of 
manufacturing and quality systems compliance, 
as applicable; 
‘‘(F) disclose to the sponsor in advance the 
topics of any consultation concerning the spon-
sor’s device that the Secretary intends to under-
take with external experts or an advisory com-
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mittee and provide the sponsor an opportunity 
to recommend such external experts; 
‘‘(G) for applications submitted under sec-
tion 515(c), provide for advisory committee 
input, as the Secretary determines appropriate 
(including in response to the request of the 
sponsor); and 
‘‘(H) assign staff to be available within a 
reasonable time to address questions by institu-
tional review committees concerning the condi-
tions and clinical testing requirements applica-
ble to the investigational use of the device pur-
suant to an exemption under section 520(g). 
‘‘(2) ADDITIONAL ACTIONS.—In addition to the 
actions described in paragraph (1), for purposes of 
expediting the development and review of devices 
designated under subsection (c), the Secretary, in 
collaboration with the device sponsor, may, as appro-
priate— 
‘‘(A) coordinate with the sponsor regarding 
early agreement on a data development plan; 
‘‘(B) take steps to ensure that the design 
of clinical trials is as efficient as practicable, 
such as through adoption of shorter or smaller 
clinical trials, application of surrogate end-
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points, and use of adaptive trial designs and 
Bayesian statistics, to the extent scientifically 
appropriate; 
‘‘(C) facilitate, to the extent scientifically 
appropriate, expedited and efficient develop-
ment and review of the device through utiliza-
tion of timely postmarket data collection, with 
regard to applications for approval under sec-
tion 515(c); and 
‘‘(D) agree to clinical protocols that the 
Secretary will consider binding on the Secretary 
and the sponsor, subject to— 
‘‘(i) changes agreed to by the sponsor 
and the Secretary; 
‘‘(ii) changes that the Secretary deter-
mines are required to prevent an unreason-
able risk to the public health; or 
‘‘(iii) the identification of a substan-
tial scientific issue determined by the Sec-
retary to be essential to the safety or effec-
tiveness of the device involved. 
‘‘(e) PRIORITY REVIEW GUIDANCE.— 
‘‘(1) CONTENT.—The Secretary shall issue 
guidance on the implementation of this section. Such 
guidance shall include the following: 
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