II 

110TH CONGRESS 

1ST SESSION S. 830 

To improve the process for the development of needed pediatric medical 

devices. 

IN THE SENATE OF THE UNITED STATES 

MARCH 8, 2007 

Mr. DODD introduced the following bill; which was read twice and referred to 

the Committee on Health, Education, Labor, and Pensions 

A BILL 

To improve the process for the development of needed 

pediatric medical 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 ‘‘Pediatric Medical De5 vice Safety and Improvement Act of 2007’’. 

6 SEC. 2. TRACKING PEDIATRIC DEVICE APPROVALS. 

7 Chapter V of the Federal Food, Drug, and Cosmetic 

8 Act (21 U.S.C. 351 et seq.) is amended by inserting after 

9 section 515 the following: 


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1 ‘‘SEC. 515A. PEDIATRIC USES OF DEVICES. 

2 ‘‘(a) NEW DEVICES.— 

3 ‘‘(1) IN GENERAL.—A person that submits to 

4 the Secretary an application under section 520(m), 

5 or an application (or supplement to an application) 

6 or a product development protocol under section 

7 515, shall include in the application or protocol the 

8 information described in paragraph (2). 

9 ‘‘(2) REQUIRED INFORMATION.—The applica10 tion or protocol described in paragraph (1) shall in11 clude, with respect to the device for which approval 

12 is sought and if readily available— 

13 ‘‘(A) a description of any pediatric sub14 populations that suffer from the disease or con15 dition that the device is intended to treat, diag16 nose, or cure; and 

17 ‘‘(B) the number of affected pediatric pa18 tients. 

19 ‘‘(3) ANNUAL REPORT.—Not later than 18 

20 months after the date of enactment of this section, 

21 and annually thereafter, the Secretary shall submit 

22 to the Committee on Health, Education, Labor, and 

23 Pensions of the Senate and the Committee on En24 ergy and Commerce of the House of Representatives 

25 a report that includes— 


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1 ‘‘(A) the number of devices approved in the 

2 year preceding the year in which the report is 

3 submitted, for which there is a pediatric sub4 population that suffers from the disease or con5 dition that the device is intended to treat, diag6 nose, or cure; 

7 ‘‘(B) the number of devices approved in 

8 the year preceding the year in which the report 

9 is submitted, labeled for use in pediatric pa10 tients; 

11 ‘‘(C) the number of pediatric devices ap12 proved in the year preceding the year in which 

13 the report is submitted, exempted from a fee 

14 pursuant to section 738(a)(2)(B)(v); and 

15 ‘‘(D) the review time for each device de16 scribed in subparagraphs (A), (B), and (C). 

17 ‘‘(b) DETERMINATION OF PEDIATRIC EFFECTIVE18 NESS BASED ON SIMILAR COURSE OF DISEASE OR CONDI19 TION OR SIMILAR EFFECT OF DEVICE ON ADULTS.— 

20 ‘‘(1) IN GENERAL.—If the course of the disease 

21 or condition and the effects of the device are suffi22 ciently similar in adults and pediatric patients, the 

23 Secretary may conclude that adult data may be used 

24 to support a determination of a reasonable assurVerDate Aug 31 2005 21:39 Mar 10, 2007 Jkt 059200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S830.IS S830

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1 ance of effectiveness in pediatric populations, as ap2 propriate. 

3 ‘‘(2) EXTRAPOLATION BETWEEN SUBPOPULA4 TIONS.—A study may not be needed in each pedi5 atric subpopulation if data from one subpopulation 

6 can be extrapolated to another subpopulation. 

7 ‘‘(c) PEDIATRIC SUBPOPULATION.—In this section, 

8 the term ‘pediatric subpopulation’ has the meaning given 

9 the term in section 520(m)(6)(E)(ii).’’. 

10 SEC. 3. MODIFICATION TO HUMANITARIAN DEVICE EXEMP11 TION. 

12 (a) IN GENERAL.—Section 520(m) of the Federal 

13 Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)) is 

14 amended— 

15 (1) in paragraph (3), by striking ‘‘No’’ and in16 serting ‘‘Except as provided in paragraph (6), no’’; 

17 (2) in paragraph (5)— 

18 (A) by inserting ‘‘, if the Secretary has 

19 reason to believe that the requirements of para20 graph (6) are no longer met,’’ after ‘‘public 

21 health’’; and 

22 (B) by adding at the end the following: ‘‘If 

23 the person granted an exemption under para24 graph (2) fails to demonstrate continued com25 pliance with the requirements of this subVerDate Aug 31 2005 21:39 Mar 10, 2007 Jkt 059200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S830.IS S830

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1 section, the Secretary may suspend or withdraw 

2 the exemption from the effectiveness require3 ments of sections 514 and 515 for a humani4 tarian device only after providing notice and an 

5 opportunity for an informal hearing.’’; 

6 (3) by striking paragraph (6) and inserting the 

7 following: 

8 ‘‘(6)(A) Except as provided in subparagraph (D), the 

9 prohibition in paragraph (3) shall not apply with respect 

10 to a person granted an exemption under paragraph (2) 

11 if each of the following conditions apply: 

12 ‘‘(i)(I) The device with respect to which the ex13 emption is granted is intended for the treatment or 

14 diagnosis of a disease or condition that occurs in pe15 diatric patients or in a pediatric subpopulation, and 

16 such device is labeled for use in pediatric patients or 

17 in a pediatric subpopulation in which the disease or 

18 condition occurs. 

19 ‘‘(II) The device was not previously approved 

20 under this subsection for the pediatric patients or 

21 the pediatric subpopulation described in subclause 

22 (I) prior to the date of enactment of the Pediatric 

23 Medical Device Safety and Improvement Act of 

24 2007. 


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1 ‘‘(ii) During any calendar year, the number of 

2 such devices distributed during that year does not 

3 exceed the annual distribution number specified by 

4 the Secretary when the Secretary grants such ex5 emption. The annual distribution number shall be 

6 based on the number of individuals affected by the 

7 disease or condition that such device is intended to 

8 treat, diagnose, or cure, and of that number, the 

9 number of individuals likely to use the device, and 

10 the number of devices reasonably necessary to treat 

11 such individuals. In no case shall the annual dis12 tribution number exceed the number identified in 

13 paragraph (2)(A). 

14 ‘‘(iii) Such person immediately notifies the Sec15 retary if the number of such devices distributed dur16 ing any calendar year exceeds the annual distribu17 tion number referred to in clause (ii). 

18 ‘‘(iv) The request for such exemption is sub19 mitted on or before October 1, 2013. 

20 ‘‘(B) The Secretary may inspect the records relating 

21 to the number of devices distributed during any calendar 

22 year of a person granted an exemption under paragraph 

23 (2) for which the prohibition in paragraph (3) does not 

24 apply. 


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1 ‘‘(C) A person may petition the Secretary to modify 

2 the annual distribution number specified by the Secretary 

3 under subparagraph (A)(ii) with respect to a device if ad4 ditional information on the number of individuals affected 

5 by the disease or condition arises, and the Secretary may 

6 modify such number but in no case shall the annual dis7 tribution number exceed the number identified in para8 graph (2)(A). 

9 ‘‘(D) If a person notifies the Secretary, or the Sec10 retary determines through an inspection under subpara11 graph (B), that the number of devices distributed during 

12 any calendar year exceeds the annual distribution number, 

13 as required under subparagraph (A)(iii), and modified 

14 under subparagraph (C), if applicable, then the prohibi15 tion in paragraph (3) shall apply with respect to such per16 son for such device for any sales of such device after such 

17 notification. 

18 ‘‘(E)(i) In this subsection, the term ‘pediatric pa19 tients’ means patients who are 21 years of age or younger 

20 at the time of the diagnosis or treatment. 

21 ‘‘(ii) In this subsection, the term ‘pediatric sub22 population’ means 1 of the following populations: 

23 ‘‘(I) Neonates. 

24 ‘‘(II) Infants. 

25 ‘‘(III) Children. 


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1 ‘‘(IV) Adolescents.’’; and 

2 (4) by adding at the end the following: 

3 ‘‘(7) The Secretary shall refer any report of an ad4 verse event regarding a device for which the prohibition 

5 under paragraph (3) does not apply pursuant to para6 graph (6)(A) that the Secretary receives to the Office of 

7 Pediatric Therapeutics, established under section 6 of the 

8 Best Pharmaceuticals for Children Act (Public Law 107– 

9 109)). In considering the report, the Director of the Office 

10 of Pediatric Therapeutics, in consultation with experts in 

11 the Center for Devices and Radiological Health, shall pro12 vide for periodic review of the report by the Pediatric Ad13 visory Committee, including obtaining any recommenda14 tions of such committee regarding whether the Secretary 

15 should take action under this Act in response to the re16 port.’’. 

17 (b) REPORT.—Not later than January 1, 2012, the 

18 Comptroller General of the United States shall submit to 

19 the Committee on Health, Education, Labor, and Pen20 sions of the Senate and the Committee on Energy and 

21 Commerce of the House of Representatives a report on 

22 the impact of allowing persons granted an exemption 

23 under section 520(m)(2) of the Federal Food, Drug, and 

24 Cosmetic Act (21 U.S.C. 360j(m)(2)) with respect to a 

25 device to profit from such device pursuant to section 


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1 520(m)(6) of such Act (21 U.S.C. 360j(m)(6)) (as amend2 ed by subsection (a)), including— 

3 (1) an assessment of whether such section 

4 520(m)(6) (as amended by subsection (a)) has in5 creased the availability of pediatric devices for condi6 tions that occur in small numbers of children, in7 cluding any increase or decrease in the number of— 

8 (A) exemptions granted under such section 

9 520(m)(2) for pediatric devices; and 

10 (B) applications approved under section 

11 515 of such Act (21 U.S.C. 360e) for devices 

12 intended to treat, diagnose, or cure conditions 

13 that occur in pediatric patients or for devices 

14 labeled for use in a pediatric population; 

15 (2) the conditions or diseases the pediatric de16 vices were intended to treat or diagnose and the esti17 mated size of the pediatric patient population for 

18 each condition or disease; 

19 (3) the costs of the pediatric devices, based on 

20 a survey of children’s hospitals; 

21 (4) the extent to which the costs of such devices 

22 are covered by health insurance; 

23 (5) the impact, if any, of allowing profit on ac24 cess to such devices for patients; 


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1 (6) the profits made by manufacturers for each 

2 device that receives an exemption; 

3 (7) an estimate of the extent of the use of the 

4 pediatric devices by both adults and pediatric popu5 lations for a condition or disease other than the con6 dition or disease on the label of such devices; 

7 (8) recommendations of the Comptroller Gen8 eral of the United States regarding the effectiveness 

9 of such section 520(m)(6) (as amended by sub10 section (a)) and whether any modifications to such 

11 section 520(m)(6) (as amended by subsection (a)) 

12 should be made; 

13 (9) existing obstacles to pediatric device devel14 opment; and 

15 (10) an evaluation of the demonstration grants 

16 described in section 5. 

17 (c) GUIDANCE.—Not later than 180 days after the 

18 date of enactment of this Act, the Commissioner of Food 

19 and Drugs shall issue guidance for institutional review 

20 committees on how to evaluate requests for approval for 

21 devices for which a humanitarian device exemption under 

22 section 520(m)(2) of the Federal Food, Drug, and Cos23 metic Act (21 U.S.C. 360j(m)(2)) has been granted. 


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1 SEC. 4. ENCOURAGING PEDIATRIC MEDICAL DEVICE RE2 SEARCH. 

3 (a) ACCESS TO FUNDING.—The Director of the Na4 tional Institutes of Health shall designate a contact point 

5 or office at the National Institutes of Health to help 

6 innovators and physicians access funding for pediatric 

7 medical device development. 

8 (b) PLAN FOR PEDIATRIC MEDICAL DEVICE RE9 SEARCH.— 

10 (1) IN GENERAL.—Not later than 180 days 

11 after the date of enactment of this Act, the Commis12 sioner of Food and Drugs, in collaboration with the 

13 Director of the National Institutes of Health and the 

14 Director of the Agency for Healthcare Research and 

15 Quality, shall submit to the Committee on Health, 

16 Education, Labor, and Pensions of the Senate and 

17 the Committee on Energy and Commerce of the 

18 House of Representatives a plan for expanding pedi19 atric medical device research and development. In 

20 developing such plan, the Commissioner of Food and 

21 Drugs shall consult with individuals and organiza22 tions with appropriate expertise in pediatric medical 

23 devices. 

24 (2) CONTENTS.—The plan under paragraph (1) 

25 shall include— 


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1 (A) the current status of federally funded 

2 pediatric medical device research; 

3 (B) any gaps in such research, which may 

4 include a survey of pediatric medical providers 

5 regarding unmet pediatric medical device needs, 

6 as needed; and 

7 (C) a research agenda for improving pedi8 atric medical device development and Food and 

9 Drug Administration clearance or approval of 

10 pediatric medical devices, and for evaluating the 

11 short- and long-term safety and effectiveness of 

12 pediatric medical devices. 

13 SEC. 5. DEMONSTRATION GRANTS FOR IMPROVING PEDI14 ATRIC DEVICE AVAILABILITY. 

15 (a) IN GENERAL.— 

16 (1) REQUEST FOR PROPOSALS.—Not later than 

17 90 days after the date of enactment of this Act, the 

18 Secretary of Health and Human Services shall issue 

19 a request for proposals for 1 or more grants or con20 tracts to nonprofit consortia for demonstration 

21 projects to promote pediatric device development. 

22 (2) DETERMINATION ON GRANTS OR CON23 TRACTS.—Not later than 180 days after the date the 

24 Secretary of Health and Human Services issues a 

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1 retary shall make a determination on the grants or 

2 contracts under this section. 

3 (b) APPLICATION.—A nonprofit consortium that de4 sires to receive a grant or contract under this section shall 

5 submit an application to the Secretary of Health and 

6 Human Services at such time, in such manner, and con7 taining such information as the Secretary may require. 

8 (c) USE OF FUNDS.—A nonprofit consortium that re9 ceives a grant or contract under this section shall— 

10 (1) encourage innovation by connecting quali11 fied individuals with pediatric device ideas with po12 tential manufacturers; 

13 (2) mentor and manage pediatric device 

14 projects through the development process, including 

15 product identification, prototype design, device devel16 opment, and marketing; 

17 (3) connect innovators and physicians to exist18 ing Federal resources, including resources from the 

19 Food and Drug Administration, the National Insti20 tutes of Health, the Small Business Administration, 

21 the Department of Energy, the Department of Edu22 cation, the National Science Foundation, the De23 partment of Veterans Affairs, the Agency for 

24 Healthcare Research and Quality, and the National 

25 Institute of Standards and Technology; 


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1 (4) assess the scientific and medical merit of 

2 proposed pediatric device projects; 

3 (5) assess business feasibility and provide busi4 ness advice; 

5 (6) provide assistance with prototype develop6 ment; and 

7 (7) provide assistance with postmarket needs, 

8 including training, logistics, and reporting. 

9 (d) COORDINATION.— 

10 (1) NATIONAL INSTITUTES OF HEALTH.—Each 

11 consortium that receives a grant or contract under 

12 this section shall— 

13 (A) coordinate with the National Institutes 

14 of Health’s pediatric device contact point or of15 fice, designated under section 4; and 

16 (B) provide to the National Institutes of 

17 Health any identified pediatric device needs 

18 that the consortium lacks sufficient capacity to 

19 address or those needs in which the consortium 

20 has been unable to stimulate manufacturer in21 terest. 

22 (2) FOOD AND DRUG ADMINISTRATION.—Each 

23 consortium that receives a grant or contract under 

24 this section shall coordinate with the Commissioner 

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1 tate the application for approval or clearance of de2 vices labeled for pediatric use. 

3 (e) AUTHORIZATION OF APPROPRIATIONS.—There 

4 are authorized to be appropriated to carry out this section 

5 $6,000,000 for each of fiscal years 2008 through 2012. 

6 SEC. 6. AMENDMENTS TO OFFICE OF PEDIATRIC THERA7 PEUTICS AND PEDIATRIC ADVISORY COM8 MITTEE. 

9 (a) OFFICE OF PEDIATRIC THERAPEUTICS.—Section 

10 6(b) of the Best Pharmaceuticals for Children Act (21 

11 U.S.C. 393a(b)) is amended by inserting ‘‘, including in12 creasing pediatric access to medical devices’’ after ‘‘pedi13 atric issues’’. 

14 (b) PEDIATRIC ADVISORY COMMITTEE.—Section 14 

15 of the Best Pharmaceuticals for Children Act (42 U.S.C. 

16 284m note) is amended— 

17 (1) in subsection (a), by inserting ‘‘(including 

18 drugs and biological products) and medical devices’’ 

19 after ‘‘therapeutics’’; and 

20 (2) in subsection (b)— 

21 (A) in paragraph (1), by inserting ‘‘(in22 cluding drugs and biological products) and med23 ical devices’’ after ‘‘therapeutics’’; and 

24 (B) in paragraph (2)— 


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1 (i) in subparagraph (A), by striking 

2 ‘‘and 505B’’ and inserting ‘‘505B, 510(k), 

3 515, and 520(m)’’; 

4 (ii) by striking subparagraph (B) and 

5 inserting the following: 

6 ‘‘(B) identification of research priorities re7 lated to therapeutics (including drugs and bio8 logical products) and medical devices for pedi9 atric populations and the need for additional 

10 diagnostics and treatments for specific pediatric 

11 diseases or conditions; and’’; and 

12 (iii) in subparagraph (C), by inserting 

13 ‘‘(including drugs and biological products) 

14 and medical devices’’ after ‘‘therapeutics’’. 

15 SEC. 7. STUDIES. 

16 (a) POSTMARKET STUDIES.—Section 522 of the Fed17 eral Food, Drug, and Cosmetic Act (21 U.S.C. 360l) is 

18 amended— 

19 (1) in subsection (a)— 

20 (A) by inserting ‘‘, or as a condition to ap21 proval of an application (or a supplement to an 

22 application) or a product development protocol 

23 under section 515 or as a condition to clearance 

24 of a premarket notification under section 


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1 510(k),’’ after ‘‘The Secretary may by order’’; 

2 and 

3 (B) by inserting ‘‘, that is expected to have 

4 significant use in pediatric populations,’’ after 

5 ‘‘health consequences’’; and 

6 (2) in subsection (b)— 

7 (A) by striking ‘‘(b) SURVEILLANCE AP8 PROVAL.—Each’’ and inserting the following: 

9 ‘‘(b) SURVEILLANCE APPROVAL.— 

10 ‘‘(1) IN GENERAL.—Each’’; 

11 (B) by striking ‘‘The Secretary, in con12 sultation’’ and inserting ‘‘Except as provided in 

13 paragraph (2), the Secretary, in consultation’’; 

14 (C) by striking ‘‘Any determination’’ and 

15 inserting ‘‘Except as provided in paragraph (2), 

16 any determination’’; and 

17 (D) by adding at the end the following: 

18 ‘‘(2) LONGER STUDIES FOR PEDIATRIC DE19 VICES.—The Secretary may by order require a pro20 spective surveillance period of more than 36 months 

21 with respect to a device that is expected to have sig22 nificant use in pediatric populations if such period of 

23 more than 36 months is necessary in order to assess 

24 the impact of the device on growth and development, 

25 or the effects of growth, development, activity level, 


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1 or other factors on the safety or efficacy of the de2 vice.’’. 

3 (b) DATABASE.— 

4 (1) IN GENERAL.— 

5 (A) ESTABLISHMENT.—The Secretary of 

6 Health and Human Services, acting through the 

7 Commissioner of Food and Drugs, shall estab8 lish a publicly accessible database of studies of 

9 medical devices that includes all studies and 

10 surveillances, described in paragraph (2)(A), 

11 that were in progress on the date of enactment 

12 of this Act or that began after such date. 

13 (B) ACCESSIBILITY.—Information included 

14 in the database under subparagraph (A) shall 

15 be in language reasonably accessible and under16 stood by individuals without specific expertise in 

17 the medical field. 

18 (2) STUDIES AND SURVEILLANCES.— 

19 (A) INCLUDED.—The database described 

20 in paragraph (1) shall include— 

21 (i) all postmarket surveillances or22 dered under section 522(a) of the Federal 

23 Food, Drug, and Cosmetic Act (21 U.S.C. 

24 360l(a)) or agreed to by the manufacturer; 

25 and 


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1 (ii) all studies agreed to by the manu2 facturer of a medial device as part of— 

3 (I) the premarket approval of 

4 such device under section 515 of the 

5 Federal Food, Drug, and Cosmetic 

6 Act (21 U.S.C. 360e); 

7 (II) the clearance of a premarket 

8 notification report under section 

9 510(k) of such Act (21 U.S.C. 

10 360(k)) with respect to such device; or 

11 (III) the submission of an appli12 cation under section 520(m) of such 

13 Act (21 U.S.C. 360j(m)) with respect 

14 to such device. 

15 (B) EXCLUDED.—The database described 

16 in paragraph (1) shall not include any studies 

17 with respect to a medical device that were com18 pleted prior to the initial approval of such de19 vice. 

20 (3) CONTENTS OF STUDY AND SURVEIL21 LANCE.—For each study or surveillance included in 

22 the database described in paragraph (1), the data23 base shall include— 

24 (A) information on the status of the study 

25 or surveillance; 


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1 (B) basic information about the study or 

2 surveillance, including the purpose, the primary 

3 and secondary outcomes, and the population 

4 targeted; 

5 (C) the expected completion date of the 

6 study or surveillance; 

7 (D) public health notifications, including 

8 safety alerts; and 

9 (E) any other information the Secretary of 

10 Health and Human Services determines appro11 priate to protect the public health. 

12 (4) ONCE COMPLETED OR TERMINATED.—In 

13 addition to the information described in paragraph 

14 (3), once a study or surveillance has been completed 

15 or if a study or surveillance is terminated, the data16 base shall also include— 

17 (A) the actual date of completion or termi18 nation; 

19 (B) if the study or surveillance was termi20 nated, the reason for termination; 

21 (C) if the study or surveillance was sub22 mitted but not accepted by the Food and Drug 

23 Administration because the study or surveil24 lance did not meet the requirements for such 


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1 study or surveillance, an explanation of the rea2 sons and any follow-up action required; 

3 (D) information about any labeling 

4 changes made to the device as a result of the 

5 study or surveillance findings; 

6 (E) information about any other decisions 

7 or actions of the Food and Drug Administra8 tion that result from the study or surveillance 

9 findings; 

10 (F) lay and technical summaries of the 

11 study or surveillance results and key findings, 

12 or an explanation as to why the results and key 

13 findings do not warrant public availability; 

14 (G) a link to any peer reviewed articles on 

15 the study or surveillance; and 

16 (H) any other information the Secretary of 

17 Health and Human Services determines appro18 priate to protect the public health. 

19 (5) PUBLIC ACCESS.—The database described 

20 in paragraph (1) shall be— 

21 (A) accessible to the general public; and 

22 (B) easily searchable by multiple criteria, 

23 including whether the study or surveillance in24 volves pediatric populations. 

Æ 


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