II 

115TH CONGRESS 

1ST SESSION S. 1069 

To establish pilot projects in order to provide timely and reliable information 

on the safety and effectiveness of cleared or approved devices. 

IN THE SENATE OF THE UNITED STATES 

MAY 8, 2017 

Mr. CASEY (for himself, Ms. WARREN, and Mr. FRANKEN) introduced the following bill; which was read twice and referred to the Committee on 

Health, Education, Labor, and Pensions 

A BILL 

To establish pilot projects in order to provide timely and 

reliable information on the safety and effectiveness of 

cleared or approved 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 ‘‘Medical Device Safety 

5 Monitoring Act’’. 

6 SEC. 2. DEVICE PILOT PROJECTS. 

7 (a) POSTMARKET PILOT.—Section 519 of the Fed8 eral Food, Drug, and Cosmetic Act (21 U.S.C. 360i) is 

9 amended by adding at the end the following: 


lotter on DSK5VPTVN1PROD with BILLS
2 

•S 1069 IS

1 ‘‘(i) PILOT PROJECTS.— 

2 ‘‘(1) IN GENERAL.—In order to provide timely 

3 and reliable information on the safety and effective4 ness of cleared or approved devices, including re5 sponses to adverse events and malfunctions, and to 

6 advance the objectives of part 803 of title 21, Code 

7 of Federal Regulations (or successor regulations), 

8 and advance the objectives of, and evaluate innova9 tive new methods of compliance with, this section 

10 and section 522, the Secretary shall, within one year 

11 of the date of enactment of this subsection, initiate 

12 one or more pilot projects for voluntary participation 

13 by a manufacturer or manufacturers of device or de14 vice type, or continue existing projects in accordance 

15 with paragraph (3), that meet all of the following re16 quirements: 

17 ‘‘(A) Are designed to efficiently generate 

18 reliable and timely safety and active surveil19 lance data for use by the Secretary or manufac20 turers of the devices that are involved in the 

21 pilot project. 

22 ‘‘(B) Inform the development of methods, 

23 systems, data criteria, and programs that could 

24 be used to support safety and active surveilVerDate Sep 11 2014 05:08 May 12, 2017 Jkt 069200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1069.IS S1069

lotter on DSK5VPTVN1PROD with BILLS
3 

•S 1069 IS

1 lance activities for devices not included in such 

2 project. 

3 ‘‘(C) Are designed and conducted in co4 ordination with a comprehensive system for 

5 evaluating medical device technology that oper6 ates under a governing board with appropriate 

7 representation of stakeholders, including con8 sumer groups and device manufacturers. 

9 ‘‘(D) Use electronic health data including 

10 claims data, patient survey data, and any other 

11 data, as the Secretary determines appropriate. 

12 ‘‘(E) Prioritize devices and device types 

13 that meet one or more of the following criteria: 

14 ‘‘(i) Devices and device types for 

15 which the collection and analysis of real 

16 world evidence regarding a device’s safety 

17 and effectiveness is likely to advance public 

18 health. 

19 ‘‘(ii) Devices and device types that are 

20 widely used. 

21 ‘‘(iii) Devices and device types, the 

22 failure of which has significant health con23 sequences. 

24 ‘‘(iv) Devices and device types for 

25 which the Secretary has received public 


lotter on DSK5VPTVN1PROD with BILLS
4 

•S 1069 IS

1 recommendations in accordance with para2 graph (2)(B) and has determined to meet 

3 one of the criteria under clauses (i) 

4 through (iii) and is appropriate for a 

5 project under this subsection. 

6 ‘‘(2) PARTICIPATION.—The Secretary shall es7 tablish the conditions and processes for— 

8 ‘‘(A) authorizing voluntary participation of 

9 a manufacturer of a device in the pilot project 

10 described in paragraph (1); and 

11 ‘‘(B) facilitating public recommendations 

12 for devices to be prioritized under the pilot 

13 project described in paragraph (1), including re14 quirements for the data necessary to support 

15 such recommendation. 

16 ‘‘(3) IMPLEMENTATION.—The Secretary may 

17 satisfy the requirements of paragraphs (1) and (2) 

18 by continuing or expanding existing projects, or by 

19 beginning new projects, that meet the criteria of 

20 subparagraphs (A) through (E) of paragraph (1) or 

21 by entering into contracts, cooperative agreements, 

22 grants, or other appropriate agreements with public 

23 or private entities that have a significant presence in 

24 the United States, and meet the following additional 

25 conditions: 


lotter on DSK5VPTVN1PROD with BILLS
5 

•S 1069 IS

1 ‘‘(A) If such public or private entities are 

2 a component of another organization, the enti3 ties have established appropriate security meas4 ures to maintain the confidentiality and privacy 

5 of the data described in paragraph (1)(D) and 

6 the entity shall not make an unauthorized dis7 closure of such data to the other components of 

8 the organization in breach of such confiden9 tiality and privacy requirements. 

10 ‘‘(B) In the case of the termination or non11 renewal of such contracts, cooperative agree12 ments, grants, or other appropriate agreements, 

13 the entities shall comply with each of the fol14 lowing: 

15 ‘‘(i) Continue to comply with the con16 fidentiality and privacy requirements under 

17 this subsection with respect to all data dis18 closed to the entity. 

19 ‘‘(ii) Return any data disclosed to 

20 such entity under this subsection to which 

21 it would not otherwise have access or, if re22 turning the data is not practicable, destroy 

23 the data. 

24 ‘‘(C) Have at least one of the following 

25 qualifications: 


lotter on DSK5VPTVN1PROD with BILLS
6 

•S 1069 IS

1 ‘‘(i) Research, statistical, epidemio2 logic, or clinical capability and expertise to 

3 conduct and complete the activities under 

4 this subsection, including the capability 

5 and expertise to provide the Secretary ac6 cess to de-identified data consistent with 

7 the requirements of this subsection. 

8 ‘‘(ii) An information technology infra9 structure in place to support electronic 

10 data and operational standards to provide 

11 security for such data, as appropriate. 

12 ‘‘(iii) Experience with, and expertise 

13 on, the development of device safety and 

14 effectiveness research and surveillance 

15 using electronic health data. 

16 ‘‘(iv) Other expertise which the Sec17 retary determines necessary to fulfill the 

18 activities under this subsection. 

19 ‘‘(4) REVIEW OF CONTRACT IN THE EVENT OF

20 A MERGER OR ACQUISITION.—The Secretary shall 

21 review a contract with a qualified entity under this 

22 subsection in the event of a merger or acquisition of 

23 the entity in order to ensure that the requirements 

24 under this subsection will continue to be met. 


lotter on DSK5VPTVN1PROD with BILLS
7 

•S 1069 IS

1 ‘‘(5) REPORT TO CONGRESS.—Not later than 

2 18 months after the date of enactment of this sub3 section, and annually thereafter, the Secretary shall 

4 submit to the Committee on Health, Education, 

5 Labor, and Pensions of the Senate and the Com6 mittee on Energy and Commerce of the House of 

7 Representatives a report containing a description of 

8 the pilot projects being conducted pursuant to this 

9 subsection, including for each pilot project— 

10 ‘‘(A) how the project is being implemented 

11 in accordance with paragraph (3) and the con12 tractor or grantee as applicable; 

13 ‘‘(B) the number of manufacturers that 

14 have agreed to participate; 

15 ‘‘(C) the data sources used; 

16 ‘‘(D) the devices or device categories in17 volved; and 

18 ‘‘(E) the number of patients involved. 

19 ‘‘(6) COMPLIANCE WITH REQUIREMENTS FOR

20 RECORDS OR REPORTS ON DEVICES.—The participa21 tion of a manufacturer in a pilot project under this 

22 subsection shall not affect the eligibility of such 

23 manufacturer to participate in any quarterly report24 ing program implemented under this Act. The Sec25 retary may determine that, for the specified time peVerDate Sep 11 2014 05:08 May 12, 2017 Jkt 069200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S1069.IS S1069

lotter on DSK5VPTVN1PROD with BILLS
8 

•S 1069 IS

1 riod to be determined by the Secretary, a manufac2 turer’s participation in a pilot project under this 

3 subsection may meet certain other requirements of 

4 this section or section 522 if— 

5 ‘‘(A) the project has demonstrated success 

6 in capturing relevant adverse event information; 

7 and 

8 ‘‘(B) the Secretary has established proce9 dures for making adverse event and safety in10 formation collected from the pilot public, to the 

11 extent possible, if collected pursuant to this sec12 tion or section 522. 

13 ‘‘(7) PRIVACY REQUIREMENTS.—With respect 

14 to the pilot projects conducted pursuant to this sub15 section— 

16 ‘‘(A) individual identifiable health informa17 tion shall not be disclosed when presenting any 

18 information from such project; and 

19 ‘‘(B) such projects shall comply with sec20 tion 264(c) of the Health Insurance Portability 

21 and Accountability Act of 1996 (42 U.S.C. 

22 1320d–2 note) and sections 552 and 552a of 

23 title 5, United States Code. 

24 ‘‘(8) OTHER COMPLIANCE.—Any pilot program 

25 undertaken in coordination with the comprehensive 


lotter on DSK5VPTVN1PROD with BILLS
9 

•S 1069 IS

1 system described in paragraph (1)(C), including 

2 pilot projects under this subsection, that relates to 

3 the use of real world evidence for devices shall com4 ply with paragraph (1)(B), the conditions listed in 

5 subparagraphs (A) and (B) of paragraph (3), and 

6 paragraphs (4), (5), (6), and (7). 

7 ‘‘(9) SUNSET.—This subsection shall cease to 

8 have force or effect on October 1, 2022.’’. 

9 (b) REPORT.—Not later than January 31, 2021, the 

10 Secretary of Health and Human Services, acting through 

11 the Commissioner of Food and Drugs, shall conduct a re12 view through an independent third party to evaluate the 

13 strengths, limitations, and appropriate use of evidence col14 lected pursuant to real world evidence pilot projects de15 scribed in the letters described in section 201(b) of the 

16 Medical Device User Fee Amendments of 2017 and sub17 section (i) of section 519 of the Federal Food, Drug, and 

18 Cosmetic Act (21 U.S.C. 360i), as amended by subsection 

19 (a), for informing premarket and postmarket decision20 making for multiple device types, and to determine wheth21 er the methods, systems, and programs in such pilot 

22 projects efficiently generate reliable and timely evidence 

23 about the effectiveness or safety surveillance of devices. 

Æ 


lotter on DSK5VPTVN1PROD with BILLS