I 

114TH CONGRESS 

1ST SESSION H. R. 2337 

To amend the Federal Food, Drug, and Cosmetic Act to authorize priority 

review for breakthrough devices. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 14, 2015 

Mr. PITTS introduced the following bill; which was referred to the Committee 

on Energy and Commerce 

A BILL 

To amend the Federal Food, Drug, and Cosmetic Act to 

authorize priority review for breakthrough devices. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. PRIORITY REVIEW FOR BREAKTHROUGH DE4 VICES. 

5 (a) IN GENERAL.—Chapter V of the Federal Food, 

6 Drug, and Cosmetic Act is amended— 

7 (1) in section 515(d)— 

8 (A) by striking paragraph (5); and 

9 (B) by redesignating paragraph (6) as 

10 paragraph (5); and 


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1 (2) by inserting after section 515A (21 U.S.C. 

2 360e–1) the following: 

3 ‘‘SEC. 515B. PRIORITY REVIEW FOR BREAKTHROUGH DE4 VICES. 

5 ‘‘(a) IN GENERAL.—In order to provide for more ef6 fective treatment or diagnosis of life-threatening or irre7 versibly debilitating human diseases or conditions, the 

8 Secretary shall establish a program to provide priority re9 view for devices— 

10 ‘‘(1) representing breakthrough technologies; 

11 ‘‘(2) for which no approved alternatives exist; 

12 ‘‘(3) offering significant advantages over exist13 ing approved or cleared alternatives, including the 

14 potential to, compared to existing approved or 

15 cleared alternatives, reduce or eliminate the need for 

16 hospitalization, improve patient quality of life, facili17 tate patients’ ability to manage their own care (such 

18 as through self-directed personal assistance), or es19 tablish long-term clinical efficiencies; or 

20 ‘‘(4) the availability of which is in the best in21 terest of patients. 

22 ‘‘(b) REQUEST FOR DESIGNATION.—A sponsor of a 

23 device may request that the Secretary designate the device 

24 for priority review under this section. Any such request 

25 for designation may be made at any time prior to the subVerDate Sep 11 2014 21:42 May 19, 2015 Jkt 049200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H2337.IH H2337

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1 mission of an application under section 515(c), a petition 

2 for classification under section 513(f)(2), or a notification 

3 under section 510(k). 

4 ‘‘(c) DESIGNATION PROCESS.— 

5 ‘‘(1) IN GENERAL.—Not later than 60 calendar 

6 days after the receipt of a request under subsection 

7 (b), the Secretary shall determine whether the device 

8 that is the subject of the request meets the criteria 

9 described in subsection (a). If the Secretary deter10 mines that the device meets the criteria, the Sec11 retary shall designate the device for priority review. 

12 ‘‘(2) REVIEW.—Review of a request under sub13 section (b) shall be undertaken by a team that is 

14 composed of experienced staff and managers of the 

15 Food and Drug Administration and is chaired by a 

16 senior manager. 

17 ‘‘(3) DESIGNATION DETERMINATION.—A deter18 mination approving or denying a request under sub19 section (b) shall be considered a significant decision 

20 under section 517A and the Secretary shall provide 

21 a written, substantive summary of the basis for the 

22 determination in accordance with section 517A(a). 

23 ‘‘(4) RECONSIDERATION.— 

24 ‘‘(A) REQUEST FOR RECONSIDERATION.— 

25 Any person whose request under subsection (b) 


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1 is denied may, within 30 days of the denial, re2 quest reconsideration of the denial in accord3 ance with section 517A(b)— 

4 ‘‘(i) based upon the submission of 

5 documents by such person; or 

6 ‘‘(ii) based upon such documents and 

7 a meeting or teleconference. 

8 ‘‘(B) RESPONSE.—Reconsideration of a 

9 designation determination under this paragraph 

10 shall be conducted in accordance with section 

11 517A(b). 

12 ‘‘(5) WITHDRAWAL.—If the Secretary approves 

13 a priority review designation for a device under this 

14 section, the Secretary may not withdraw the des15 ignation based on the fact that the criteria specified 

16 in subsection (a) are no longer met because of the 

17 subsequent clearance or approval of another device 

18 that was designated under— 

19 ‘‘(A) this section; or 

20 ‘‘(B) section 515(d)(5) (as in effect imme21 diately prior to the enactment of the 21st Cen22 tury Cures Act). 

23 ‘‘(d) PRIORITY REVIEW.— 


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1 ‘‘(1) ACTIONS.—For purposes of expediting the 

2 development and review of devices designated under 

3 subsection (c), the Secretary shall— 

4 ‘‘(A) assign a team of staff, including a 

5 team leader with appropriate subject matter ex6 pertise and experience, for each device for 

7 which a request is submitted under subsection 

8 (b); 

9 ‘‘(B) provide for oversight of the team by 

10 senior agency personnel to facilitate the effi11 cient development of the device and the efficient 

12 review of any submission described in sub13 section (b) for the device; 

14 ‘‘(C) adopt an efficient process for timely 

15 dispute resolution; 

16 ‘‘(D) provide for interactive communication 

17 with the sponsor of the device during the review 

18 process; 

19 ‘‘(E) expedite the Secretary’s review of 

20 manufacturing and quality systems compliance, 

21 as applicable; 

22 ‘‘(F) disclose to the sponsor in advance the 

23 topics of any consultation concerning the spon24 sor’s device that the Secretary intends to under25 take with external experts or an advisory comVerDate Sep 11 2014 21:42 May 19, 2015 Jkt 049200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H2337.IH H2337

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1 mittee and provide the sponsor an opportunity 

2 to recommend such external experts; 

3 ‘‘(G) for applications submitted under sec4 tion 515(c), provide for advisory committee 

5 input, as the Secretary determines appropriate 

6 (including in response to the request of the 

7 sponsor); and 

8 ‘‘(H) assign staff to be available within a 

9 reasonable time to address questions by institu10 tional review committees concerning the condi11 tions and clinical testing requirements applica12 ble to the investigational use of the device pur13 suant to an exemption under section 520(g). 

14 ‘‘(2) ADDITIONAL ACTIONS.—In addition to the 

15 actions described in paragraph (1), for purposes of 

16 expediting the development and review of devices 

17 designated under subsection (c), the Secretary, in 

18 collaboration with the device sponsor, may, as appro19 priate— 

20 ‘‘(A) coordinate with the sponsor regarding 

21 early agreement on a data development plan; 

22 ‘‘(B) take steps to ensure that the design 

23 of clinical trials is as efficient as practicable, 

24 such as through adoption of shorter or smaller 

25 clinical trials, application of surrogate endVerDate Sep 11 2014 21:42 May 19, 2015 Jkt 049200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H2337.IH H2337

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1 points, and use of adaptive trial designs and 

2 Bayesian statistics, to the extent scientifically 

3 appropriate; 

4 ‘‘(C) facilitate, to the extent scientifically 

5 appropriate, expedited and efficient develop6 ment and review of the device through utiliza7 tion of timely postmarket data collection, with 

8 regard to applications for approval under sec9 tion 515(c); and 

10 ‘‘(D) agree to clinical protocols that the 

11 Secretary will consider binding on the Secretary 

12 and the sponsor, subject to— 

13 ‘‘(i) changes agreed to by the sponsor 

14 and the Secretary; 

15 ‘‘(ii) changes that the Secretary deter16 mines are required to prevent an unreason17 able risk to the public health; or 

18 ‘‘(iii) the identification of a substan19 tial scientific issue determined by the Sec20 retary to be essential to the safety or effec21 tiveness of the device involved. 

22 ‘‘(e) PRIORITY REVIEW GUIDANCE.— 

23 ‘‘(1) CONTENT.—The Secretary shall issue 

24 guidance on the implementation of this section. Such 

25 guidance shall include the following: 


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1 ‘‘(A) The process for a person to seek a 

2 priority review designation. 

3 ‘‘(B) A template for requests under sub4 section (b). 

5 ‘‘(C) The criteria the Secretary will use in 

6 evaluating a request for priority review. 

7 ‘‘(D) The standards the Secretary will use 

8 in assigning a team of staff, including team 

9 leaders, to review devices designated for priority 

10 review, including any training required for such 

11 personnel on effective and efficient review. 

12 ‘‘(2) PROCESS.—Prior to finalizing the guid13 ance under paragraph (1), the Secretary shall pro14 pose such guidance for public comment. 

15 ‘‘(f) CONSTRUCTION.— 

16 ‘‘(1) PURPOSE.—This section is intended to en17 courage the Secretary and provide the Secretary suf18 ficient authorities to apply efficient and flexible ap19 proaches to expedite the development of, and 

20 prioritize the agency’s review of, devices that rep21 resent breakthrough technologies. 

22 ‘‘(2) CONSTRUCTION.—Nothing in this section 

23 shall be construed to alter the criteria and standards 

24 for evaluating an application pursuant to section 

25 515(c), a report and request for classification under 


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1 section 513(f)(2), or a report under section 510(k), 

2 including the recognition of valid scientific evidence 

3 as described in section 513(a)(3)(B), and consider4 ation of the least burdensome means of evaluating 

5 device effectiveness or demonstrating substantial 

6 equivalence between devices with differing techno7 logical characteristics, as applicable. Nothing in this 

8 section alters the authority of the Secretary to act 

9 on an application pursuant to section 515(d) before 

10 completion of an establishment inspection, as the 

11 Secretary deems appropriate.’’. 

12 (b) CONFORMING AMENDMENT RELATED TO DES13 IGNATION DETERMINATIONS.—Section 517A(a)(1) of the 

14 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360g– 

15 1(a)(1)) is amended by inserting ‘‘a request for designa16 tion under section 515B,’’ after ‘‘an application under sec17 tion 515,’’. 

Æ 


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