I 

110TH CONGRESS 

1ST SESSION H. R. 1494 

To improve the process for the development of needed pediatric medical 

devices. 

IN THE HOUSE OF REPRESENTATIVES 

MARCH 13, 2007 

Mr. MARKEY (for himself and Mr. ROGERS of Michigan) introduced the 

following bill; which was referred to the Committee on Energy and Commerce 

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 02:42 Mar 15, 2007 Jkt 059200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H1494.IH H1494

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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.—For purposes of 

8 this section, the term ‘pediatric subpopulation’ has the 

9 meaning given 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 02:42 Mar 15, 2007 Jkt 059200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H1494.IH H1494

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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.’’; and 

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

7 after paragraph (5) the following new paragraphs: 

8 ‘‘(6)(A) Except as provided in subparagraph 

9 (D), the prohibition in paragraph (3) shall not apply 

10 with respect to a person granted an exemption under 

11 paragraph (2) if each of the following conditions 

12 apply: 

13 ‘‘(i)(I) The device with respect to which 

14 the exemption is granted is intended for the 

15 treatment or diagnosis of a disease or condition 

16 that occurs in pediatric patients or in a pedi17 atric subpopulation, and such device is labeled 

18 for use in pediatric patients or in a pediatric 

19 subpopulation in which the disease or condition 

20 occurs. 

21 ‘‘(II) The device was not previously ap22 proved under this subsection for the pediatric 

23 patients or the pediatric subpopulation de24 scribed in subclause (I) prior to the date of enVerDate Aug 31 2005 02:42 Mar 15, 2007 Jkt 059200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H1494.IH H1494

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1 actment of the Pediatric Medical Device Safety 

2 and Improvement Act of 2007. 

3 ‘‘(ii) During any calendar year, the num4 ber of such devices distributed during that year 

5 does not exceed the annual distribution number 

6 specified by the Secretary when the Secretary 

7 grants such exemption. The annual distribution 

8 number shall be based on the number of indi9 viduals affected by the disease or condition that 

10 such device is intended to treat, diagnose, or 

11 cure, and of that number, the number of indi12 viduals likely to use the device, and the number 

13 of devices reasonably necessary to treat such in14 dividuals. In no case shall the annual distribu15 tion number exceed the number identified in 

16 paragraph (2)(A). 

17 ‘‘(iii) Such person immediately notifies the 

18 Secretary if the number of such devices distrib19 uted during any calendar year exceeds the an20 nual distribution number referred to in clause 

21 (ii). 

22 ‘‘(iv) The request for such exemption is 

23 submitted on or before October 1, 2013. 

24 ‘‘(B) The Secretary may inspect the records re25 lating to the number of devices distributed during 


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1 any calendar year of a person granted an exemption 

2 under paragraph (2) for which the prohibition in 

3 paragraph (3) does not apply. 

4 ‘‘(C) A person may petition the Secretary to 

5 modify the annual distribution number specified by 

6 the Secretary under subparagraph (A)(ii) with re7 spect to a device if additional information on the 

8 number of individuals affected by the disease or con9 dition arises, and the Secretary may modify such 

10 number but in no case shall the annual distribution 

11 number exceed the number identified in paragraph 

12 (2)(A). 

13 ‘‘(D) If a person notifies the Secretary, or the 

14 Secretary determines through an inspection under 

15 subparagraph (B), that the number of devices dis16 tributed during any calendar year exceeds the an17 nual distribution number, as required under sub18 paragraph (A)(iii), and modified under subpara19 graph (C), if applicable, then the prohibition in 

20 paragraph (3) shall apply with respect to such per21 son for such device for any sales of such device after 

22 such notification. 

23 ‘‘(E)(i) In this subsection, the term ‘pediatric 

24 patients’ means patients who are 21 years of age or 

25 younger at the time of the diagnosis or treatment. 


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1 ‘‘(ii) In this subsection, the term ‘pediatric sub2 population’ means 1 of the following populations: 

3 ‘‘(I) Neonates. 

4 ‘‘(II) Infants. 

5 ‘‘(III) Children. 

6 ‘‘(IV) Adolescents. 

7 ‘‘(7) The Secretary shall refer any report of an 

8 adverse event regarding a device for which the prohi9 bition under paragraph (3) does not apply pursuant 

10 to paragraph (6)(A) that the Secretary receives to 

11 the Office of Pediatric Therapeutics, established 

12 under section 6 of the Best Pharmaceuticals for 

13 Children Act (Public Law 107–109)). In considering 

14 the report, the Director of the Office of Pediatric 

15 Therapeutics, in consultation with experts in the 

16 Center for Devices and Radiological Health, shall 

17 provide for periodic review of the report by the Pedi18 atric Advisory Committee, including obtaining any 

19 recommendations of such committee regarding 

20 whether the Secretary should take action under this 

21 Act in response to the report. 

22 ‘‘(8) In consultation with the Office of Pediatric 

23 Therapeutics and the Center for Devices and Radio24 logical Health, the Secretary shall provide for an an25 nual review by the Pediatric Advisory Committee of 


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1 all devices described in section 520(m)(6) to ensure 

2 that the exemption under section 520(m)(2) remains 

3 appropriate for the pediatric populations for which it 

4 is granted.’’. 

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

6 Comptroller General of the United States shall submit to 

7 the Committee on Health, Education, Labor, and Pen8 sions of the Senate and the Committee on Energy and 

9 Commerce of the House of Representatives a report on 

10 the impact of allowing persons granted an exemption 

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

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

13 device to profit from such device pursuant to section 

14 520(m)(6) of such Act (21 U.S.C. 360j(m)(6)) (as amend15 ed by subsection (a)), including— 

16 (1) an assessment of whether such section 

17 520(m)(6) (as amended by subsection (a)) has in18 creased the availability of pediatric devices for condi19 tions that occur in small numbers of children, in20 cluding any increase or decrease in the number of— 

21 (A) exemptions granted under such section 

22 520(m)(2) for pediatric devices; and 

23 (B) applications approved under section 

24 515 of such Act (21 U.S.C. 360e) for devices 

25 intended to treat, diagnose, or cure conditions 


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1 that occur in pediatric patients or for devices 

2 labeled for use in a pediatric population; 

3 (2) the conditions or diseases the pediatric de4 vices were intended to treat or diagnose and the esti5 mated size of the pediatric patient population for 

6 each condition or disease; 

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

8 a survey of children’s hospitals; 

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

10 are covered by health insurance; 

11 (5) the impact, if any, of allowing profit on ac12 cess to such devices for patients; 

13 (6) the profits made by manufacturers for each 

14 device that receives an exemption; 

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

16 pediatric devices by both adults and pediatric popu17 lations for a condition or disease other than the con18 dition or disease on the label of such devices; 

19 (8) recommendations of the Comptroller Gen20 eral of the United States regarding the effectiveness 

21 of such section 520(m)(6) (as amended by sub22 section (a)) and whether any modifications to such 

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

24 should be made; 


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1 (9) existing obstacles to pediatric device devel2 opment; and 

3 (10) an evaluation of the demonstration grants 

4 described in section 5. 

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

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

7 and Drugs shall issue guidance for institutional review 

8 committees on how to evaluate requests for approval for 

9 devices for which a humanitarian device exemption under 

10 section 520(m)(2) of the Federal Food, Drug, and Cos11 metic Act (21 U.S.C. 360j(m)(2)) has been granted. 

12 SEC. 4. ENCOURAGING PEDIATRIC MEDICAL DEVICE RE13 SEARCH. 

14 (a) ACCESS TO FUNDING.—The Director of the Na15 tional Institutes of Health shall designate a contact point 

16 or office at the National Institutes of Health to help 

17 innovators and physicians access funding for pediatric 

18 medical device development. 

19 (b) PLAN FOR PEDIATRIC MEDICAL DEVICE RE20 SEARCH.— 

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

22 after the date of enactment of this Act, the Commis23 sioner of Food and Drugs, in collaboration with the 

24 Director of the National Institutes of Health and the 

25 Director of the Agency for Healthcare Research and 


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1 Quality, shall submit to the Committee on Health, 

2 Education, Labor, and Pensions of the Senate and 

3 the Committee on Energy and Commerce of the 

4 House of Representatives a plan for expanding pedi5 atric medical device research and development. In 

6 developing such plan, the Commissioner of Food and 

7 Drugs shall consult with individuals and organiza8 tions with appropriate expertise in pediatric medical 

9 devices. 

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

11 shall include— 

12 (A) the current status of federally funded 

13 pediatric medical device research; 

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

15 include a survey of pediatric medical providers 

16 regarding unmet pediatric medical device needs, 

17 as needed; and 

18 (C) a research agenda for improving pedi19 atric medical device development and Food and 

20 Drug Administration clearance or approval of 

21 pediatric medical devices, and for evaluating the 

22 short- and long-term safety and effectiveness of 

23 pediatric medical devices. 


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1 SEC. 5. DEMONSTRATION GRANTS FOR IMPROVING PEDI2 ATRIC DEVICE AVAILABILITY. 

3 (a) IN GENERAL.— 

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

5 90 days after the date of enactment of this Act, the 

6 Secretary of Health and Human Services shall issue 

7 a request for proposals for 1 or more grants or con8 tracts to nonprofit consortia for demonstration 

9 projects to promote pediatric device development. 

10 (2) DETERMINATION ON GRANTS OR CON11 TRACTS.—Not later than 180 days after the date the 

12 Secretary of Health and Human Services issues a 

13 request for proposals under paragraph (1), the Sec14 retary shall make a determination on the grants or 

15 contracts under this section. 

16 (b) APPLICATION.—A nonprofit consortium that de17 sires to receive a grant or contract under this section shall 

18 submit an application to the Secretary of Health and 

19 Human Services at such time, in such manner, and con20 taining such information as the Secretary may require. 

21 (c) USE OF FUNDS.—A nonprofit consortium that re22 ceives a grant or contract under this section shall— 

23 (1) encourage innovation by connecting quali24 fied individuals with pediatric device ideas with po25 tential manufacturers; 


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1 (2) mentor and manage pediatric device 

2 projects through the development process, including 

3 product identification, prototype design, device devel4 opment, and marketing; 

5 (3) connect innovators and physicians to exist6 ing Federal resources, including resources from the 

7 Food and Drug Administration, the National Insti8 tutes of Health, the Small Business Administration, 

9 the Department of Energy, the Department of Edu10 cation, the National Science Foundation, the De11 partment of Veterans Affairs, the Agency for 

12 Healthcare Research and Quality, and the National 

13 Institute of Standards and Technology; 

14 (4) assess the scientific and medical merit of 

15 proposed pediatric device projects; 

16 (5) assess business feasibility and provide busi17 ness advice; 

18 (6) provide assistance with prototype develop19 ment; and 

20 (7) provide assistance with postmarket needs, 

21 including training, logistics, and reporting. 

22 (d) COORDINATION.— 

23 (1) NATIONAL INSTITUTES OF HEALTH.—Each 

24 consortium that receives a grant or contract under 

25 this section shall— 


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1 (A) coordinate with the National Institutes 

2 of Health’s pediatric device contact point or of3 fice, designated under section 4; and 

4 (B) provide to the National Institutes of 

5 Health any identified pediatric device needs 

6 that the consortium lacks sufficient capacity to 

7 address or those needs in which the consortium 

8 has been unable to stimulate manufacturer in9 terest. 

10 (2) FOOD AND DRUG ADMINISTRATION.—Each 

11 consortium that receives a grant or contract under 

12 this section shall coordinate with the Commissioner 

13 of Food and Drugs and device companies to facili14 tate the application for approval or clearance of de15 vices labeled for pediatric use. 

16 (e) AUTHORIZATION OF APPROPRIATIONS.—There 

17 are authorized to be appropriated to carry out this section 

18 $6,000,000 for each of fiscal years 2008 through 2012. 

19 SEC. 6. AMENDMENTS TO OFFICE OF PEDIATRIC THERA20 PEUTICS AND PEDIATRIC ADVISORY COM21 MITTEE. 

22 (a) OFFICE OF PEDIATRIC THERAPEUTICS.—Section 

23 6(b) of the Best Pharmaceuticals for Children Act (21 

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1 creasing pediatric access to medical devices’’ after ‘‘pedi2 atric issues’’. 

3 (b) PEDIATRIC ADVISORY COMMITTEE.—Section 14 

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

5 284m note) is amended— 

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

7 drugs and biological products) and medical devices’’ 

8 after ‘‘therapeutics’’; and 

9 (2) in subsection (b)— 

10 (A) in paragraph (1), by inserting ‘‘(in11 cluding drugs and biological products) and med12 ical devices’’ after ‘‘therapeutics’’; and 

13 (B) in paragraph (2)— 

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

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

16 515, and 520(m)’’; 

17 (ii) by striking subparagraph (B) and 

18 inserting the following: 

19 ‘‘(B) identification of research priorities re20 lated to therapeutics (including drugs and bio21 logical products) and medical devices for pedi22 atric populations and the need for additional 

23 diagnostics and treatments for specific pediatric 

24 diseases or conditions;’’; and 


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

2 ‘‘(including drugs and biological products) 

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

4 SEC. 7. STUDIES. 

5 (a) POSTMARKET STUDIES.—Section 522 of the Fed6 eral Food, Drug, and Cosmetic Act (21 U.S.C. 360l) is 

7 amended— 

8 (1) in subsection (a)— 

9 (A) by inserting ‘‘, or as a condition to ap10 proval of an application (or a supplement to an 

11 application) or a product development protocol 

12 under section 515 or as a condition to clearance 

13 of a premarket notification under section 

14 510(k),’’ after ‘‘The Secretary may by order’’; 

15 and 

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

17 significant use in pediatric populations,’’ after 

18 ‘‘health consequences’’; and 

19 (2) in subsection (b)— 

20 (A) by striking ‘‘(b) SURVEILLANCE AP21 PROVAL.—Each’’ and inserting the following: 

22 ‘‘(b) SURVEILLANCE APPROVAL.— 

23 ‘‘(1) IN GENERAL.—Each’’; 


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1 (B) by striking ‘‘The Secretary, in con2 sultation’’ and inserting ‘‘Except as provided in 

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

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

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

6 any determination’’; and 

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

8 ‘‘(2) LONGER STUDIES FOR PEDIATRIC DE9 VICES.—The Secretary may by order require a pro10 spective surveillance period of more than 36 months 

11 with respect to a device that is expected to have sig12 nificant use in pediatric populations if such period of 

13 more than 36 months is necessary in order to assess 

14 the impact of the device on growth and development, 

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

16 or other factors on the safety or efficacy of the de17 vice.’’. 

18 (b) DATABASE.— 

19 (1) IN GENERAL.— 

20 (A) ESTABLISHMENT.—The Secretary of 

21 Health and Human Services, acting through the 

22 Commissioner of Food and Drugs, shall estab23 lish a publicly accessible database of studies of 

24 medical devices that includes all studies and 

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


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1 that were in progress on the date of enactment 

2 of this Act or that began after such date. 

3 (B) ACCESSIBILITY.—Information included 

4 in the database under subparagraph (A) shall 

5 be in language reasonably accessible and under6 stood by individuals without specific expertise in 

7 the medical field. 

8 (2) STUDIES AND SURVEILLANCES.— 

9 (A) INCLUDED.—The database described 

10 in paragraph (1) shall include— 

11 (i) all postmarket surveillances or12 dered under section 522(a) of the Federal 

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

14 360l(a)) or agreed to by the manufacturer; 

15 and 

16 (ii) all studies agreed to by the manu17 facturer of a medical device in conjunction 

18 with— 

19 (I) the premarket approval of 

20 such device under section 515 of the 

21 Federal Food, Drug, and Cosmetic 

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

23 (II) the clearance of a premarket 

24 notification report under section 


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1 510(k) of such Act (21 U.S.C. 

2 360(k)) with respect to such device; or 

3 (III) the submission of an appli4 cation under section 520(m) of such 

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

6 to such device. 

7 (B) EXCLUDED.—The database described 

8 in paragraph (1) shall not include any studies 

9 with respect to a medical device that were com10 pleted prior to the initial approval of such de11 vice. 

12 (3) CONTENTS OF STUDY AND SURVEIL13 LANCE.—For each study or surveillance included in 

14 the database described in paragraph (1), the data15 base shall include— 

16 (A) information on the status of the study 

17 or surveillance; 

18 (B) basic information about the study or 

19 surveillance, including the purpose, the primary 

20 and secondary outcomes, and the population 

21 targeted; 

22 (C) the expected completion date of the 

23 study or surveillance; 

24 (D) public health notifications, including 

25 safety alerts; and 


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1 (E) any other information the Secretary of 

2 Health and Human Services determines appro3 priate to protect the public health. 

4 (4) ONCE COMPLETED OR TERMINATED.—In 

5 addition to the information described in paragraph 

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

7 or if a study or surveillance is terminated, the data8 base shall also include— 

9 (A) the actual date of completion or termi10 nation; 

11 (B) if the study or surveillance was termi12 nated, the reason for termination; 

13 (C) if the study or surveillance was sub14 mitted but not accepted by the Food and Drug 

15 Administration because the study or surveil16 lance did not meet the requirements for such 

17 study or surveillance, an explanation of the rea18 sons and any follow-up action required; 

19 (D) information about any labeling 

20 changes made to the device as a result of the 

21 study or surveillance findings; 

22 (E) information about any other decisions 

23 or actions of the Food and Drug Administra24 tion that result from the study or surveillance 

25 findings; 


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1 (F) lay and technical summaries of the 

2 study or surveillance results and key findings, 

3 or an explanation as to why the results and key 

4 findings do not warrant public availability; 

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

6 the study or surveillance; and 

7 (H) any other information the Secretary of 

8 Health and Human Services determines appro9 priate to protect the public health. 

10 (5) PUBLIC ACCESS.—The database described 

11 in paragraph (1) shall be— 

12 (A) accessible to the general public; and 

13 (B) easily searchable by multiple criteria, 

14 including whether the study or surveillance in15 volves pediatric populations. 

Æ 


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