II 

109TH CONGRESS 

2D SESSION S. 4098 

To improve the process for the development of needed pediatric medical 

devices. 

IN THE SENATE OF THE UNITED STATES 

DECEMBER 6, 2006 

Mr. DODD (for himself and Mr. DEWINE) 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 2006’’. 

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 03:51 Dec 09, 2006 Jkt 059200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S4098.IS S4098

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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 SEC. 3. MODIFICATION TO HUMANITARIAN DEVICE EXEMP8 TION. 

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

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

11 amended— 

12 (1) in paragraph (3), by striking ‘‘No’’ and in13 serting ‘‘Except as provided in paragraph (6), no’’; 

14 (2) in paragraph (5)— 

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

16 reason to believe that the requirements of para17 graph (6) are no longer met,’’ after ‘‘public 

18 health’’; and 

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

20 the person granted an exemption under para21 graph (2) fails to demonstrate continued com22 pliance with the requirements of this sub23 section, the Secretary may suspend or withdraw 

24 the exemption from the effectiveness require25 ments of sections 514 and 515 for a humaniVerDate Aug 31 2005 03:51 Dec 09, 2006 Jkt 059200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S4098.IS S4098

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1 tarian device only after providing notice and an 

2 opportunity for an informal hearing.’’; 

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

4 following: 

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

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

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

8 if each of the following conditions apply: 

9 ‘‘(i)(I) The device with respect to which the ex10 emption is granted is intended for the treatment or 

11 diagnosis of a disease or condition that occurs in pe12 diatric patients or in a pediatric subpopulation, and 

13 such device is labeled for use in pediatric patients or 

14 in a pediatric subpopulation in which the disease or 

15 condition occurs. 

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

17 under this subsection for the pediatric patients or 

18 the pediatric subpopulation described in subclause 

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

20 Medical Device Safety and Improvement Act of 

21 2006. 

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

23 such devices distributed during that year does not 

24 exceed the annual distribution number specified by 

25 the Secretary when the Secretary grants such exVerDate Aug 31 2005 03:51 Dec 09, 2006 Jkt 059200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S4098.IS S4098

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1 emption. The annual distribution number shall be 

2 based on the number of individuals affected by the 

3 disease or condition that such device is intended to 

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

5 number of individuals likely to use the device, and 

6 the number of devices reasonably necessary to treat 

7 such individuals. In no case shall the annual dis8 tribution number exceed the number identified in 

9 paragraph (2)(A). 

10 ‘‘(iii) Such person immediately notifies the Sec11 retary if the number of such devices distributed dur12 ing any calendar year exceeds the annual distribu13 tion number referred to in clause (ii). 

14 ‘‘(iv) The request for such exemption is sub15 mitted on or before October 1, 2012. 

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

17 to the number of devices distributed during any calendar 

18 year of a person granted an exemption under paragraph 

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

20 apply. 

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

22 the annual distribution number specified by the Secretary 

23 under subparagraph (A)(ii) with respect to a device if ad24 ditional information on the number of individuals affected 

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


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1 modify such number but in no case shall the annual dis2 tribution number exceed the number identified in para3 graph (2)(A). 

4 ‘‘(D) If a person notifies the Secretary, or the Sec5 retary determines through an inspection under subpara6 graph (B), that the number of devices distributed during 

7 any calendar year exceeds the annual distribution number, 

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

9 under subparagraph (C), if applicable, then the prohibi10 tion in paragraph (3) shall apply with respect to such per11 son for such device for any sales of such device after such 

12 notification. 

13 ‘‘(E)(i) In this subsection, the term ‘pediatric pa14 tients’ means patients who are 21 years of age or younger 

15 at the time of the diagnosis or treatment. 

16 ‘‘(ii) In this subsection, the term ‘pediatric sub17 population’ means 1 of the following populations: 

18 ‘‘(I) Neonates. 

19 ‘‘(II) Infants. 

20 ‘‘(III) Children. 

21 ‘‘(IV) Adolescents.’’; and 

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

23 ‘‘(7) The Secretary shall refer any report of an ad24 verse event regarding a device for which the prohibition 

25 under paragraph (3) does not apply pursuant to paraVerDate Aug 31 2005 03:51 Dec 09, 2006 Jkt 059200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S4098.IS S4098

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1 graph (6)(A) that the Secretary receives to the Office of 

2 Pediatric Therapeutics, established under section 6 of the 

3 Best Pharmaceuticals for Children Act (Public Law 107– 

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

5 of Pediatric Therapeutics, in consultation with experts in 

6 the Center for Devices and Radiological Health, shall pro7 vide for periodic review of the report by the Pediatric Ad8 visory Committee, including obtaining any recommenda9 tions of such committee regarding whether the Secretary 

10 should take action under this Act in response to the re11 port.’’. 

12 (b) REPORT.—Not later than January 1, 2011, the 

13 Comptroller General of the United States shall submit to 

14 the Committee on Health, Education, Labor, and Pen15 sions of the Senate and the Committee on Energy and 

16 Commerce of the House of Representatives a report on 

17 the impact of allowing persons granted an exemption 

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

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

20 device to profit from such device pursuant to section 

21 520(m)(6) of such Act (21 U.S.C. 360j(m)(6)) (as amend22 ed by subsection (a)), including— 

23 (1) an assessment of whether such section 

24 520(m)(6) (as amended by subsection (a)) has in25 creased the availability of pediatric devices for condiVerDate Aug 31 2005 03:51 Dec 09, 2006 Jkt 059200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S4098.IS S4098

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1 tions that occur in small numbers of children, in2 cluding any increase or decrease in the number of— 

3 (A) exemptions granted under such section 

4 520(m)(2) for pediatric devices; and 

5 (B) applications approved under section 

6 515 of such Act (21 U.S.C. 360e) for devices 

7 intended to treat, diagnose, or cure conditions 

8 that occur in pediatric patients or for devices 

9 labeled for use in a pediatric population; 

10 (2) the conditions or diseases the pediatric de11 vices were intended to treat or diagnose and the esti12 mated size of the pediatric patient population for 

13 each condition or disease; 

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

15 a survey of children’s hospitals; 

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

17 are covered by health insurance; 

18 (5) the impact, if any, of allowing profit on ac19 cess to such devices for patients; 

20 (6) the profits made by manufacturers for each 

21 device that receives an exemption; 

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

23 pediatric devices by both adults and pediatric popu24 lations for a condition or disease other than the con25 dition or disease on the label of such devices; 


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1 (8) recommendations of the Comptroller Gen2 eral of the United States regarding the effectiveness 

3 of such section 520(m)(6) (as amended by sub4 section (a)) and whether any modifications to such 

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

6 should be made; 

7 (9) existing obstacles to pediatric device devel8 opment; and 

9 (10) an evaluation of the demonstration grants 

10 described in section 5. 

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

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

13 and Drugs shall issue guidance for institutional review 

14 committees on how to evaluate requests for approval for 

15 devices for which a humanitarian device exemption under 

16 section 520(m)(2) of the Federal Food, Drug, and Cos17 metic Act (21 U.S.C. 360j(m)(2)) has been granted. 

18 SEC. 4. ENCOURAGING PEDIATRIC MEDICAL DEVICE RE19 SEARCH. 

20 (a) ACCESS TO FUNDING.—The Director of the Na21 tional Institutes of Health shall designate a contact point 

22 or office at the National Institutes of Health to help 

23 innovators and physicians access funding for pediatric 

24 medical device development. 


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1 (b) PLAN FOR PEDIATRIC MEDICAL DEVICE RE2 SEARCH.— 

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

4 after the date of enactment of this Act, the Commis5 sioner of Food and Drugs, in collaboration with the 

6 Director of the National Institutes of Health and the 

7 Director of the Agency for Healthcare Research and 

8 Quality, shall submit to the Committee on Health, 

9 Education, Labor, and Pensions of the Senate and 

10 the Committee on Energy and Commerce of the 

11 House of Representatives a plan for expanding pedi12 atric medical device research and development. In 

13 developing such plan, the Commissioner of Food and 

14 Drugs shall consult with individuals and organiza15 tions with appropriate expertise in pediatric medical 

16 devices. 

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

18 shall include— 

19 (A) the current status of federally funded 

20 pediatric medical device research; 

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

22 include a survey of pediatric medical providers 

23 regarding unmet pediatric medical device needs, 

24 as needed; and 


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1 (C) a research agenda for improving pedi2 atric medical device development and Food and 

3 Drug Administration clearance or approval of 

4 pediatric medical devices, and for evaluating the 

5 short- and long-term safety and effectiveness of 

6 pediatric medical devices. 

7 SEC. 5. DEMONSTRATION GRANTS FOR IMPROVING PEDI8 ATRIC DEVICE AVAILABILITY. 

9 (a) IN GENERAL.— 

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

11 90 days after the date of enactment of this Act, the 

12 Secretary of Health and Human Services shall issue 

13 a request for proposals for 1 or more grants or con14 tracts to nonprofit consortia for demonstration 

15 projects to promote pediatric device development. 

16 (2) DETERMINATION ON GRANTS OR CON17 TRACTS.—Not later than 180 days after the date the 

18 Secretary of Health and Human Services issues a 

19 request for proposals under paragraph (1), the Sec20 retary shall make a determination on the grants or 

21 contracts under this section. 

22 (b) APPLICATION.—A nonprofit consortium that de23 sires to receive a grant or contract under this section shall 

24 submit an application to the Secretary of Health and 


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1 Human Services at such time, in such manner, and con2 taining such information as the Secretary may require. 

3 (c) USE OF FUNDS.—A nonprofit consortium that re4 ceives a grant or contract under this section shall— 

5 (1) encourage innovation by connecting quali6 fied individuals with pediatric device ideas with po7 tential manufacturers; 

8 (2) mentor and manage pediatric device 

9 projects through the development process, including 

10 product identification, prototype design, device devel11 opment, and marketing; 

12 (3) connect innovators and physicians to exist13 ing Federal resources, including resources from the 

14 Food and Drug Administration, the National Insti15 tutes of Health, the Small Business Administration, 

16 the Department of Energy, the Department of Edu17 cation, the National Science Foundation, the De18 partment of Veterans Affairs, the Agency for 

19 Healthcare Research and Quality, and the National 

20 Institute of Standards and Technology; 

21 (4) assess the scientific and medical merit of 

22 proposed pediatric device projects; 

23 (5) assess business feasibility and provide busi24 ness advice; 


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1 (6) provide assistance with prototype develop2 ment; and 

3 (7) provide assistance with postmarket needs, 

4 including training, logistics, and reporting. 

5 (d) COORDINATION.— 

6 (1) NATIONAL INSTITUTES OF HEALTH.—Each 

7 consortium that receives a grant or contract under 

8 this section shall— 

9 (A) coordinate with the National Institutes 

10 of Health’s pediatric device contact point or of11 fice, designated under section 4; and 

12 (B) provide to the National Institutes of 

13 Health any identified pediatric device needs 

14 that the consortium lacks sufficient capacity to 

15 address or those needs in which the consortium 

16 has been unable to stimulate manufacturer in17 terest. 

18 (2) FOOD AND DRUG ADMINISTRATION.—Each 

19 consortium that receives a grant or contract under 

20 this section shall coordinate with the Commissioner 

21 of Food and Drugs and device companies to facili22 tate the application for approval or clearance of de23 vices labeled for pediatric use. 


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1 (e) AUTHORIZATION OF APPROPRIATIONS.—There 

2 are authorized to be appropriated to carry out this section 

3 $6,000,000 for each of fiscal years 2007 through 2011. 

4 SEC. 6. AMENDMENTS TO OFFICE OF PEDIATRIC THERA5 PEUTICS AND PEDIATRIC ADVISORY COM6 MITTEE. 

7 (a) OFFICE OF PEDIATRIC THERAPEUTICS.—Section 

8 6(b) of the Best Pharmaceuticals for Children Act (21 

9 U.S.C. 393a(b)) is amended by inserting ‘‘, including in10 creasing pediatric access to medical devices’’ after ‘‘pedi11 atric issues’’. 

12 (b) PEDIATRIC ADVISORY COMMITTEE.—Section 14 

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

14 284m note) is amended— 

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

16 drugs and biological products) and medical devices’’ 

17 after ‘‘therapeutics’’; and 

18 (2) in subsection (b)— 

19 (A) in paragraph (1), by inserting ‘‘(in20 cluding drugs and biological products) and med21 ical devices’’ after ‘‘therapeutics’’; and 

22 (B) in paragraph (2)— 

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

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

25 515, and 520(m)’’; 


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1 (ii) by striking subparagraph (B) and 

2 inserting the following: 

3 ‘‘(B) identification of research priorities re4 lated to therapeutics (including drugs and bio5 logical products) and medical devices for pedi6 atric populations and the need for additional 

7 diagnostics and treatments for specific pediatric 

8 diseases or conditions; and’’; and 

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

10 ‘‘(including drugs and biological products) 

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

12 SEC. 7. STUDIES. 

13 (a) POSTMARKET STUDIES.—Section 522 of the Fed14 eral Food, Drug, and Cosmetic Act (21 U.S.C. 360l) is 

15 amended— 

16 (1) in subsection (a)— 

17 (A) by inserting ‘‘, or as a condition to ap18 proval of an application (or a supplement to an 

19 application) or a product development protocol 

20 under section 515 or as a condition to clearance 

21 of a premarket notification report under section 

22 510(k),’’ after ‘‘The Secretary may by order’’; 

23 and 


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

2 significant use in pediatric populations,’’ after 

3 ‘‘health consequences’’; and 

4 (2) in subsection (b)— 

5 (A) by striking ‘‘(b) SURVEILLANCE AP6 PROVAL.—Each’’ and inserting the following: 

7 ‘‘(b) SURVEILLANCE APPROVAL.— 

8 ‘‘(1) IN GENERAL.—Each’’; 

9 (B) by striking ‘‘The Secretary, in con10 sultation’’ and inserting ‘‘Except as provided in 

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

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

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

14 any determination’’; and 

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

16 ‘‘(2) LONGER STUDIES FOR PEDIATRIC DE17 VICES.—The Secretary may by order require a pro18 spective surveillance period of more than 36 months 

19 with respect to a device that is expected to have sig20 nificant use in pediatric populations if such period of 

21 more than 36 months is necessary in order to assess 

22 the impact of the device on growth and development, 

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

24 or other factors on the safety or efficacy of the de25 vice.’’. 


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1 (b) DATABASE.— 

2 (1) IN GENERAL.— 

3 (A) ESTABLISHMENT.—The Secretary of 

4 Health and Human Services, acting through the 

5 Commissioner of Food and Drugs, shall estab6 lish a publicly accessible database of studies of 

7 medical devices that includes all studies and 

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

9 that were in progress on the date of enactment 

10 of this Act or that began after such date. 

11 (B) ACCESSIBILITY.—Information included 

12 in the database under subparagraph (A) shall 

13 be in language reasonably accessible and under14 stood by individuals without specific expertise in 

15 the medical field. 

16 (2) STUDIES AND SURVEILLANCES.— 

17 (A) INCLUDED.—The database described 

18 in paragraph (1) shall include— 

19 (i) all postmarket surveillances or20 dered under section 522(a) of the Federal 

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

22 360l(a)) or agreed to by the manufacturer; 

23 and 


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1 (ii) all other studies completed by the 

2 manufacturer with respect to a medical de3 vice after— 

4 (I) the premarket approval of 

5 such device under section 515 of the 

6 Federal Food, Drug, and Cosmetic 

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

8 (II) the clearance of a premarket 

9 notification report under section 

10 510(k) of such Act (21 U.S.C. 

11 360(k)) with respect to such device; or 

12 (III) submission of an application 

13 under section 520(m) of such Act (21 

14 U.S.C. 360j(m)) with respect to such 

15 device. 

16 (B) EXCLUDED.—The database described 

17 in paragraph (1) shall not include any studies 

18 with respect to a medical device that were com19 pleted prior to the initial approval of such de20 vice. 

21 (3) CONTENTS OF STUDY AND SURVEIL22 LANCE.—For each study or surveillance included in 

23 the database described in paragraph (1), the data24 base shall include— 


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1 (A) information on the status of the study 

2 or surveillance; 

3 (B) basic information about the study or 

4 surveillance, including the purpose, the primary 

5 and secondary outcomes, and the population 

6 targeted; 

7 (C) the expected completion date of the 

8 study or surveillance; 

9 (D) public health notifications, including 

10 safety alerts; and 

11 (E) any other information the Secretary of 

12 Health and Human Services determines appro13 priate to protect the public health. 

14 (4) ONCE COMPLETED OR TERMINATED.—In 

15 addition to the information described in paragraph 

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

17 or if a study or surveillance is terminated, the data18 base shall also include— 

19 (A) the actual date of completion or termi20 nation; 

21 (B) if the study or surveillance was termi22 nated, the reason for termination; 

23 (C) if the study or surveillance was sub24 mitted but not accepted by the Food and Drug 

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1 lance did not meet the requirements for such 

2 study or surveillance, an explanation of the rea3 sons and any follow-up action required; 

4 (D) information about any labeling 

5 changes made to the device as a result of the 

6 study or surveillance findings; 

7 (E) information about any other decisions 

8 or actions of the Food and Drug Administra9 tion that result from the study or surveillance 

10 findings; 

11 (F) lay and technical summaries of the 

12 study or surveillance results and key findings, 

13 or an explanation as to why the results and key 

14 findings do not warrant public availability; 

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

16 the study or surveillance; and 

17 (H) any other information the Secretary of 

18 Health and Human Services determines appro19 priate to protect the public health. 

20 (5) PUBLIC ACCESS.—The database described 

21 in paragraph (1) shall be— 

22 (A) accessible to the general public; and 

23 (B) easily searchable by multiple criteria, 

24 including whether the study or surveillance in25 volves pediatric populations. 


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1 (c) MEDICAL DEVICE CODING.—The Secretary of 

2 Health and Human Services, in consultation with the 

3 Commissioner of Food and Drugs, shall adopt voluntary 

4 national standards for medical device coding. In adopting 

5 voluntary national standards for medical device coding, 

6 the Secretary of Health and Human Services shall coordi7 nate with other efforts by the Secretary to adopt and im8 plement standards for the electronic exchange of health 

9 information. 

Æ 


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