II 

Calendar No. 412 

114TH CONGRESS 

2D SESSION S. 1077 

To provide for expedited development of and priority review for breakthrough 

devices. 

IN THE SENATE OF THE UNITED STATES 

APRIL 23, 2015 

Mr. BURR (for himself, Mr. BENNET, Mr. HATCH, and Mr. DONNELLY) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

APRIL 5, 2016 

Reported by Mr. ALEXANDER, with an amendment 

[Strike out all after the enacting clause and insert the part printed in italic] 

A BILL 

To provide for expedited development of and 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. SHORT TITLE. 

4 This Act may be cited as the ‘‘Advancing Break5 through Devices for Patients Act of 2015’’. 


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1 SEC. 2. EXPEDITED DEVELOPMENT OF AND PRIORITY RE2 VIEW FOR BREAKTHROUGH DEVICES. 

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

4 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend5 ed by inserting after section 515A the following: 

6 ‘‘SEC. 515B. EXPEDITED DEVELOPMENT OF AND PRIORITY 

7 REVIEW FOR BREAKTHROUGH DEVICES. 

8 ‘‘(a) IN GENERAL.—In order to provide for more ef9 fective treatment or diagnosis of life-threatening or irre10 versibly debilitating human disease or conditions, the Sec11 retary shall establish a program to expedite the develop12 ment of and provide for the priority review for devices— 

13 ‘‘(1) representing breakthrough technologies; 

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

15 ‘‘(3) offering significant advantages over exist16 ing approved or cleared alternatives, including the 

17 potential, compared to existing approved alter18 natives, to reduce or eliminate the need for hos19 pitalization, improve patient quality of life, facilitate 

20 patients’ ability to manage their own care (such as 

21 through self-directed personal assistance), or estab22 lish long-term clinical efficiencies; or 

23 ‘‘(4) the availability of which is in the best in24 terest of patients. 

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

26 device may request that the Secretary designate the device 


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1 for expedited development and priority review under this 

2 section. Any such request for designation may be made 

3 at any time prior to the submission of an application 

4 under section 515(c), a petition for classification under 

5 section 513(f)(2), or a notification under section 510(k). 

6 ‘‘(c) DESIGNATION PROCESS.— 

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

8 days after the receipt of a request under subsection 

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

10 that is the subject of the request meets the criteria 

11 described in subsection (a). If the Secretary deter12 mines that the device meets the criteria, the Sec13 retary shall designate the device for expedited devel14 opment and priority review. 

15 ‘‘(2) REVIEW.—Review of a request under sub16 section (b) shall be undertaken by a team that is 

17 composed of experienced staff and managers of the 

18 Food and Drug Administration and is chaired by a 

19 senior manager. 

20 ‘‘(3) WITHDRAWAL.—The Secretary may not 

21 withdraw a designation granted under this section 

22 on the basis of the criteria under subsection (a) no 

23 longer applying because of the subsequent clearance 

24 or approval of another device that— 

25 ‘‘(A) was designated under this section; or 


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1 ‘‘(B) was given priority review under sec2 tion 515(d)(5), as in effect prior to the date of 

3 enactment of the Advancing Breakthrough De4 vices for Patients Act of 2015. 

5 ‘‘(d) EXPEDITED DEVELOPMENT AND PRIORITY RE6 VIEW.— 

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

8 development and review of devices designated under 

9 subsection (c) the Secretary shall— 

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

11 team leader with appropriate subject matter ex12 pertise and experience, for each device for 

13 which a request is submitted under subsection 

14 (b); 

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

16 senior agency personnel to facilitate the effi17 cient development of the device and the efficient 

18 review of any submission described in sub19 section (b) for the device; 

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

21 dispute resolution; 

22 ‘‘(D) provide for interactive and timely 

23 communication with the sponsor of the device 

24 during the development program and review 

25 process; 


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

2 manufacturing and quality systems compliance, 

3 as applicable; 

4 ‘‘(F) disclose to the sponsor not less than 

5 5 business days in advance the topics of any 

6 consultation the Secretary intends to undertake 

7 with external experts or an advisory committee 

8 concerning the sponsor’s device and provide the 

9 sponsor the opportunity to recommend such ex10 ternal experts; 

11 ‘‘(G) provide for advisory committee input, 

12 as the Secretary determines appropriate (in13 cluding in response to the request of the spon14 sor) for applications submitted under section 

15 515(c); and 

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

17 reasonable time to address questions by institu18 tional review committees concerning the condi19 tions and clinical testing requirements applica20 ble to the investigational use of the device pur21 suant to an exemption under section 520(g). 

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

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

24 expediting the development and review of devices 

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


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1 collaboration with the device sponsor, may, as appro2 priate— 

3 ‘‘(A) coordinate with the sponsor regarding 

4 early agreement on a data development plan; 

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

6 of clinical trials is as efficient as practicable, 

7 when scientifically appropriate, such as through 

8 adoption of shorter or smaller clinical trials, ap9 plication of surrogate endpoints, and the use of 

10 adaptive trial designs and Bayesian statistics, 

11 to the extent scientifically appropriate; 

12 ‘‘(C) facilitate, when scientifically appro13 priate, expedited and efficient development and 

14 review of the device through utilization of time15 ly post-market data collection with regard to 

16 application for approval under section 515(c); 

17 and 

18 ‘‘(D) agree in writing to clinical protocols 

19 that the Secretary will consider binding on the 

20 Secretary and the sponsor, subject to— 

21 ‘‘(i) changes to such protocols agreed 

22 to in writing by the sponsor and the Sec23 retary; or 

24 ‘‘(ii) a decision, made by the director 

25 of the office responsible for reviewing the 


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1 device submission, that a substantial sci2 entific issue essential to determining the 

3 safety or effectiveness of such device exists, 

4 provided that such decision is in writing, 

5 and is made only after the Secretary pro6 vides to the device sponsor or applicant an 

7 opportunity for a meeting at which the di8 rector and the sponsor or applicant are 

9 present and at which the director docu10 ments the substantial scientific issue. 

11 ‘‘(e) PRIORITY REVIEW GUIDANCE.— 

12 ‘‘(1) CONTENT.—Not later than 1 year after 

13 the date of enactment of the Advancing Break14 through Devices for Patients Act of 2015, the Sec15 retary shall issue guidance on the implementation of 

16 this section. Such guidance shall— 

17 ‘‘(A) set forth the process by which a per18 son may seek a designation under subsection 

19 (c); 

20 ‘‘(B) provide a template for requests under 

21 subsection (b); 

22 ‘‘(C) identify the criteria the Secretary will 

23 use in evaluating a request for designation 

24 under this section; and 


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1 ‘‘(D) identify the standards the Secretary 

2 will use in assigning a team of staff, including 

3 team leaders, to review devices designated for 

4 expedited development and priority review, in5 cluding any training required for such per6 sonnel to ensure effective and efficient review. 

7 ‘‘(2) PROCESS.—Prior to finalizing the guid8 ance under paragraph (1), the Secretary shall seek 

9 public comment on a proposed guidance. 

10 ‘‘(f) CONSTRUCTION.— 

11 ‘‘(1) PURPOSE.—This section is intended to en12 courage the Secretary and provide the Secretary suf13 ficient authorities to apply efficient and flexible ap14 proaches to expedite the development of, and 

15 prioritize the Food and Drug Administration’s re16 view of, devices that represent breakthrough devices. 

17 ‘‘(2) RULE OF CONSTRUCTION.—Nothing in 

18 this section shall be construed to affect— 

19 ‘‘(A) the criteria and standards for evalu20 ating an application pursuant to section 515(c), 

21 a report and request for classification under 

22 section 513(f)(2), or a report under section 

23 510(k), including the recognition of valid sci24 entific evidence as described in section 

25 513(a)(3)(B) and consideration and application 


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1 of the least burdensome means of evaluating de2 vice effectiveness or demonstrating substantial 

3 equivalence between devices with differing tech4 nological characteristics, as applicable; 

5 ‘‘(B) the authority of the Secretary with 

6 respect to clinical holds under section 

7 520(g)(8)(A); or 

8 ‘‘(C) the authority of the Secretary to act 

9 on an application pursuant to section 515(d) 

10 before completion of an establishment inspec11 tion, as the Secretary determines appropriate.’’. 

12 (b) DOCUMENTATION AND REVIEW OF SIGNIFICANT

13 DECISIONS.—Section 517A(a)(1) of the Federal Food, 

14 Drug, and Cosmetic Act (21 U.S.C. 360g–1(a)(1)) is 

15 amended by inserting ‘‘a request for designation under 

16 section 515B,’’ after ‘‘application under section 515,’’. 

17 (c) TERMINATION OF PREVIOUS PROGRAM.— 

18 (1) IN GENERAL.—Section 515(d) of the Fed19 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

20 360e(d)) is amended— 

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

22 (B) by redesignating paragraph (6) as 

23 paragraph (5). 

24 (2) CONFORMING AMENDMENT.—Section 

25 737(5) of the Federal Food, Drug, and Cosmetics 


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1 Act (21 U.S.C. 379i(5)) is amended by striking 

2 ‘‘515(d)(6)’’ and inserting ‘‘515(d)(5)’’. 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Advancing Breakthrough 

5 Devices for Patients Act of 2016’’. 

6 SEC. 2. EXPEDITED DEVELOPMENT OF AND PRIORITY RE7 VIEW FOR BREAKTHROUGH DEVICES. 

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

9 Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended 

10 by inserting after section 515A the following: 

11 ‘‘SEC. 515B. EXPEDITED DEVELOPMENT OF AND PRIORITY 

12 REVIEW FOR BREAKTHROUGH DEVICES. 

13 ‘‘(a) PURPOSE.—The purpose of this section is to en14 courage the Secretary, and provide the Secretary with suffi15 cient authority, to apply efficient and flexible approaches 

16 to expedite the development of, and prioritize the Food and 

17 Drug Administration’s review of, devices that represent 

18 breakthrough technologies. 

19 ‘‘(b) ESTABLISHMENT OF PROGRAM.—The Secretary 

20 shall establish a program to expedite the development of and 

21 provide for the priority review for devices, as determined 

22 by the Secretary— 

23 ‘‘(1) that provide for more effective treatment or 

24 diagnosis of life-threatening or irreversibly debili25 tating human disease or conditions; and 


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1 ‘‘(2)(A) that represent breakthrough technologies; 

2 ‘‘(B) for which no approved or cleared alter3 natives exist; 

4 ‘‘(C) that offer significant advantages over exist5 ing approved or cleared alternatives, including the 

6 potential, compared to existing approved alternatives, 

7 to reduce or eliminate the need for hospitalization, 

8 improve patient quality of life, facilitate patients’ 

9 ability to manage their own care (such as through 

10 self-directed personal assistance), or establish long11 term clinical efficiencies; or 

12 ‘‘(D) the availability of which is in the best in13 terest of patients. 

14 ‘‘(c) REQUEST FOR DESIGNATION.—A sponsor of a de15 vice may request that the Secretary designate such device 

16 for expedited development and priority review under this 

17 section. Any such request for designation may be made at 

18 any time prior to the submission of an application under 

19 section 515(c) or a petition for classification under section 

20 513(f)(2). 

21 ‘‘(d) DESIGNATION PROCESS.— 

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

23 days after the receipt of a request under subsection 

24 (c), the Secretary shall determine whether the device 

25 that is the subject of the request meets the criteria deVerDate Sep 11 2014 20:57 Apr 05, 2016 Jkt 059200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6203 E:\BILLS\S1077.RS S1077

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1 scribed in subsection (b). If the Secretary determines 

2 that the device meets the criteria, the Secretary shall 

3 designate the device for expedited development and 

4 priority review. 

5 ‘‘(2) REVIEW.—Review of a request under sub6 section (c) shall be undertaken by a team that is com7 posed of experienced staff and senior managers of the 

8 Food and Drug Administration. 

9 ‘‘(3) WITHDRAWAL.—The Secretary may not 

10 withdraw a designation granted under this section on 

11 the basis of the criteria under subsection (b) no longer 

12 applying because of the subsequent clearance or ap13 proval of another device that— 

14 ‘‘(A) was designated under this section; or 

15 ‘‘(B) was given priority review under sec16 tion 515(d)(5), as in effect prior to the date of 

17 enactment of the Advancing Breakthrough De18 vices for Patients Act of 2016. 

19 ‘‘(e) EXPEDITED DEVELOPMENT AND PRIORITY RE20 VIEW.— 

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

22 development and review of devices designated under 

23 subsection (d) the Secretary shall— 

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

25 team leader with appropriate subject matter exVerDate Sep 11 2014 20:57 Apr 05, 2016 Jkt 059200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6203 E:\BILLS\S1077.RS S1077

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1 pertise and experience, for each device for which 

2 a request is submitted under subsection (c); 

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

4 senior agency personnel to facilitate the efficient 

5 development of the device and the efficient review 

6 of any submission described in subsection (c) for 

7 the device; 

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

9 dispute resolution; 

10 ‘‘(D) provide for interactive and timely 

11 communication with the sponsor of the device 

12 during the development program and review 

13 process; 

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

15 manufacturing and quality systems compliance, 

16 as applicable; 

17 ‘‘(F) disclose to the sponsor, not less than 5 

18 business days in advance, the topics of any con19 sultation the Secretary intends to undertake with 

20 external experts or an advisory committee con21 cerning the sponsor’s device and provide the 

22 sponsor the opportunity to recommend such ex23 ternal experts; 

24 ‘‘(G) provide for advisory committee input, 

25 as the Secretary determines appropriate (includVerDate Sep 11 2014 20:57 Apr 05, 2016 Jkt 059200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6203 E:\BILLS\S1077.RS S1077

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1 ing in response to the request of the sponsor) for 

2 applications submitted under section 515(c); and 

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

4 reasonable time to address questions by institu5 tional review committees concerning the condi6 tions and clinical testing requirements applica7 ble to the investigational use of the device pursu8 ant to an exemption under section 520(g). 

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

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

11 expediting the development and review of devices des12 ignated under subsection (d), the Secretary, in col13 laboration with the device sponsor, may, as appro14 priate— 

15 ‘‘(A) coordinate with the sponsor regarding 

16 early agreement on a data development plan; 

17 ‘‘(B) take steps to ensure that the design of 

18 clinical trials is as efficient and flexible as prac19 ticable, when scientifically appropriate; 

20 ‘‘(C) facilitate, when scientifically appro21 priate, expedited and efficient development and 

22 review of the device through utilization of timely 

23 postmarket data collection with regard to appli24 cation for approval under section 515(c); and 


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1 ‘‘(D) agree in writing to clinical protocols 

2 that the Secretary will consider binding on the 

3 Secretary and the sponsor, subject to— 

4 ‘‘(i) changes to such protocols agreed to 

5 in writing by the sponsor and the Sec6 retary; or 

7 ‘‘(ii) a decision, made by the director 

8 of the office responsible for reviewing the de9 vice submission, that a substantial scientific 

10 issue essential to determining the safety or 

11 effectiveness of such device exists, provided 

12 that such decision is in writing, and is 

13 made only after the Secretary provides to 

14 the device sponsor or applicant an oppor15 tunity for a meeting at which the director 

16 and the sponsor or applicant are present 

17 and at which the director documents the 

18 substantial scientific issue. 

19 ‘‘(f) PRIORITY REVIEW GUIDANCE.— 

20 ‘‘(1) CONTENT.—Not later than 1 year after the 

21 date of enactment of the Advancing Breakthrough De22 vices for Patients Act of 2016, the Secretary shall 

23 issue guidance on the implementation of this section. 

24 Such guidance shall— 


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1 ‘‘(A) set forth the process by which a person 

2 may seek a designation under subsection (d); 

3 ‘‘(B) provide a template for requests under 

4 subsection (c); 

5 ‘‘(C) identify the criteria the Secretary will 

6 use in evaluating a request for designation under 

7 this section; and 

8 ‘‘(D) identify the criteria and processes the 

9 Secretary will use to assign a team of staff, in10 cluding team leaders, to review devices des11 ignated for expedited development and priority 

12 review, including any training required for such 

13 personnel to ensure effective and efficient review. 

14 ‘‘(2) PROCESS.—Prior to finalizing the guidance 

15 under paragraph (1), the Secretary shall seek public 

16 comment on a proposed guidance. 

17 ‘‘(g) RULE OF CONSTRUCTION.—Nothing in this sec18 tion shall be construed to affect— 

19 ‘‘(1) the criteria and standards for evaluating an 

20 application pursuant to section 515(c), a report and 

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

22 report under section 510(k), including the recognition 

23 of valid scientific evidence as described in section 

24 513(a)(3)(B) and consideration and application of 

25 the least burdensome means of evaluating device effecVerDate Sep 11 2014 20:57 Apr 05, 2016 Jkt 059200 PO 00000 Frm 00016 Fmt 6652 Sfmt 6203 E:\BILLS\S1077.RS S1077

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1 tiveness or demonstrating substantial equivalence be2 tween devices with differing technological characteris3 tics, as applicable; 

4 ‘‘(2) the authority of the Secretary with respect 

5 to clinical holds under section 520(g)(8)(A); 

6 ‘‘(3) the authority of the Secretary to act on an 

7 application pursuant to section 515(d) before comple8 tion of an establishment inspection, as the Secretary 

9 determines appropriate; or 

10 ‘‘(4) the authority of the Secretary with respect 

11 to postmarket surveillance under sections 519(h) and 

12 522.’’. 

13 (b) DOCUMENTATION AND REVIEW OF SIGNIFICANT

14 DECISIONS.—Section 517A(a)(1) of the Federal Food, 

15 Drug, and Cosmetic Act (21 U.S.C. 360g–1(a)(1)) is 

16 amended by inserting ‘‘a request for designation under sec17 tion 515B,’’ after ‘‘application under section 515,’’. 

18 (c) TERMINATION OF PREVIOUS PROGRAM.— 

19 (1) IN GENERAL.—Section 515(d) of the Federal 

20 Food, Drug, and Cosmetic Act (21 U.S.C. 360e(d)) is 

21 amended— 

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

23 (B) by redesignating paragraph (6) as 

24 paragraph (5). 


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1 (2) CONFORMING AMENDMENT.—Section 737(5) 

2 of the Federal Food, Drug, and Cosmetics Act (21 

3 U.S.C. 379i(5)) is amended by striking ‘‘515(d)(6)’’ 

4 and inserting ‘‘515(d)(5)’’. 

5 (d) REPORT.—On January 1, 2017, the Secretary of 

6 Health and Human Services, acting through the Commis7 sioner of Food and Drugs, shall issue a report to the Com8 mittee on Health, Education, Labor, and Pensions of the 

9 Senate and the Committee on Energy and Commerce of the 

10 House of Representatives— 

11 (1) on the program under section 515B of Fed12 eral Food, Drug, and Cosmetic Act, as added by this 

13 Act, in bringing safe and effective devices included in 

14 such program to patients as soon as possible; and 

15 (2) that includes recommendations, if any, to 

16 strengthen the program to better meet patient device 

17 needs in a manner as timely as possible. 


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Calendar No. 412 

114TH CONGRESS 

2D SESSION S. 1077 

A BILL 

To provide for expedited development of and 

priority review for breakthrough devices. 

APRIL 5, 2016 

Reported with an amendment 


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