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Report to Congress: Premarket Approval of Pediatric Uses of Devices - FY 2008

Submitted Pursuant to Section 515A of the Federal Food, Drug, and Cosmetic Act

U.S. Department of Health and Human Services

Food and Drug Administration

Frank M. Torti, M.D., M.P.H.
Acting Commissioner of Food and Drugs

Executive Summary 

Section 515A(a)(3) of the Federal Food, Drug, and Cosmetic Act¹ (FD&C Act) requires the Food and Drug Administration (FDA) to submit an annual report that provides information concerning premarket approvals of devices in terms of pediatric use. This is FDA’s first report pursuant to this requirement. The report uses information from FDA’s Center for Devices and Radiological Health (CDRH), and reflects approvals made during FY 2008.

As this is FDA’s first report under section 515A, we provide additional background information about the history of FDA’s activities to promote the development of safe and effective pediatric devices and to protect the pediatric subpopulations during the course of clinical trials. This report highlights the following information:

• Fifteen out of 27 original and panel track supplement PMAs, and 2 out of 2 HDE applications devices, were approved to treat, diagnose, or cure a disease or condition for which there is a pediatric subpopulation suffering from that disease or condition during the period from October 1, 2007 through September 30, 2008 (FY 2008.)
• Two devices approved during FY 2008 were labeled for use in pediatric patients.
• None of the 29 devices approved in FY 2008 were exempt from user fees because none had proposed conditions of use intended solely for a pediatric population.
• Information about each device approval, including its review time, appears in this report at Appendix A.  

Table of Contents

1. Introduction
2. Background
   1. Information required under section 515A(a)
   2. Implementation of Section 515A(a)
3. Information reported under Section 515A(a)
   1. Organization of Information in this Report
   2. Total Number of Approved Devices
   3. Approved Devices Labeled for Use in Pediatric Patients
   4. Pediatric Devices Exempt From User Fees
   5. Review Time for Each Device
4. Conclusion

Appendix A: Device Approvals and Review Times Report

I. Introduction

In 2007, Congress passed the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Public Law 110-85). The FDAAA amended the FD&C Act and added several new provisions to it.

Section 302 of the FDAAA added new section 515A, “Pediatric Uses of Devices,” to the FD&C Act. Section 515A(a)(3) of the FD&C Act states that:

Not later than 18 months after the date of the enactment of this section, and annually thereafter, the Secretary shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that includes –

1. the number of devices approved in the year preceding the year in which the report is submitted, for which there is a pediatric subpopulation that suffers from the disease or condition that the device is intended to treat, diagnose, or cure;
2. the number of devices approved in the year preceding the year in which the report is submitted, labeled for use in pediatric patients;
3. the number of pediatric devices approved in the year preceding the year in which the report is submitted, exempted from a fee pursuant to section 738(a)(2)(B)(v); and
4. the review time for each device described in subparagraphs (A), (B), and (C).

This report is FDA’s first report pursuant to section 515A(a)(3) of FD&C Act since FDAAA’s enactment. The report provides some background information regarding section 515A of the FD&C Act and our implementation of that provision. It then provides the data and information required under section 515A(a)(3) of the FD&C Act for approvals made during fiscal year (FY) 2008.

II. Background

A. What Information Does Section 515A(a) of the FD&C Act Require?

Section 515A(a) of the FD&C Act requires persons submitting an application under section 520(m) of the FD&C Act,² or an application (including a supplement to such an application) or a product development protocol under section 515 of the FD&C Act³ to include (if readily available):

• A description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure; and
• The number of affected pediatric patients.

For the purposes of this report, section 520(m)(6)(E)(ii) of the FD&C Act defines “pediatric subpopulation” to mean one of the following populations:

• Neonates
• Infants
• Children
• Adolescents

Section 515A of the FD&C Act and other provisions in FDAAA are intended to encourage the development of devices for use in pediatric patients. The House Report for FDAAA described the need for the legislation as follows:

Pediatric medical devices are used to treat or diagnose diseases and conditions in patients from birth through age 21. Some products are designed specifically for children, while others are borrowed from adult applications or produced for more general use.

Children have specific medical needs that must be considered when medical and surgical devices are prescribed. Devices that have not been studied for use in children may not accommodate the unique needs of children, such as allowing for expandable growth, and accommodating their active lifestyles and differing metabolism.⁴

B. How Has FDA Implemented Section 515A(a) of the FD&C Act?

FDA and Congress have both been interested in the development of pediatric medical devices. For example, the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Public Law 107-250) added several new provisions to the Act to promote the development of safe and effective pediatric devices and to protect this vulnerable patient population during the course of clinical trials involving such products. As part of the implementation of these provisions, FDA issued two guidance documents. The first, Guidance for Industry and FDA Staff - Pediatric Expertise for Advisory Panels implemented the instruction in section 515(c) of the Act to ensure, where appropriate, that advisory panels include or consult with one or more pediatric experts. The second, Guidance for Industry and FDA Staff - Premarket Assessment of Pediatric Medical Devices, also sought to ensure that pediatric expertise is available to FDA Advisory Panels, when appropriate, to help address the intent of the pediatric provisions of MDUFMA.

As another example, section 3 of the Medical Devices Technical Corrections Act of 2004 (Public Law 108-214) required the Secretary of Health and Human Services to submit a “report on the barriers to the availability of devices intended for the treatment or diagnosis of diseases and conditions that affect children.” FDA sought comment from interested parties, including consumers, researchers, healthcare practitioners, members of the device industry, and professional and trade associations, by holding a stakeholder meeting and publishing a notice in the Federal Register requesting comment. FDA provided the report to Congress in October 2004. The report is available online.

FDA also have examined specific pediatric device issues and issued guidance documents pertaining to pediatric device matters. For example, on January 26, 2006, FDA held a public workshop entitled, “FDA Workshop on Regulatory Process for Pediatric Mechanical Circulatory Support Devices (Ventricular Assist Devices),” which addressed the regulatory approval process for pediatric ventricular assist device approval (minutes available online). More recently, working with the National Institutes of Health (NIH), FDA helped to develop a draft “Pediatric Device Development Plan”. FDA, NIH, and the Agency for Healthcare Research and Quality worked together to form an Interagency Pediatric Devices Working Group. On July 23, 2008, the three agencies held a public workshop to:

• Inform the community of the current status of pediatric device development;
• Describe available mechanisms for device product registration;
• Describe available mechanisms for pediatric device project funding;
• Understand what stakeholders see to be important areas of study;
• Determine gaps in knowledge and where the needs for research are; and
• Discuss ways to gather the information needed to move ahead, such as overcoming barriers, handling logistics, determining classes of devices to study, and identifying available databases, registries, and surveillance systems.

Additionally, on August 5, 2008, FDA issued a draft guidance document titled, Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff – Humanitarian Device Exemption (HDE) Regulation: Questions and Answers. The guidance answers commonly asked questions about humanitarian use devices, including questions related to the pediatric device requirements set forth in FDAAA.

III. Specific Information to be Reported under Section 515A(a) of the FD&C Act

A. How Did FDA Organize the Information?

FDA has organized the information in this section to correspond with the information specified by the FD&C Act. Although FDA interpret 515A(a) to apply to applications received after enactment of FDAAA, FDA is providing information on all device approvals for FY 2008 including applications pending at the time of FDAAA enactment.

B. What is the Number of Devices Approved for Which There is a Pediatric Subpopulation Suffering from the Disease or Condition that the Device is Intended to Treat, Diagnose, or Cure?

Fifteen out of 27 original and panel track supplement PMAs, and 2 out of 2 HDE applications devices, were approved to treat, diagnose, or cure a disease or condition for which there is a pediatric subpopulation suffering from that disease or condition during the period from October 1, 2007 through September 30, 2008 (FY 2008.)

C. How Many Devices Were Approved and Labeled for Use in Pediatric Patients?

Two devices approved during FY 2008 were labeled for use in pediatric patients.

D. How Many Pediatric Devices Were Exempted from a Fee Pursuant to Section 738(a)(2)(B)(v) of the Act?

None of the 29 devices approved in FY 2008 were exempt from user fees because none had proposed conditions of use intended solely for a pediatric population.

E. What was the review time for each device described in subparagraphs (A), (B), and (C) of section 515A(a)(1)(3) of the FD&C Act?

Information about each device approval, including its review time, appears in this report at Appendix A. “FDA Review Days” are the number of days FDA reviewed the document, not counting time periods where an application was on hold waiting on additional information requested from the sponsor. “Total Review Days” is a running count from the filing date through the approval date.

IV. Conclusion

The information contained in this year’s report provides information and an initial accounting with respect to the approval of devices that may be used in pediatric patients, as required by section 515A of the FD&C Act. The report also summarizes FDA’s activities prior to the effective date of this new statutory provision to promote the development of pediatric devices.

¹ Section 515A was added by section 302 of the Food and Drug Administration Amendments Act of 2007, P.L. 110-85.

² Applications under section 520(m) of the FD&C Act are commonly known as humanitarian device exemption applications (HDEs).

³ Applications under section 515 of the Act are commonly known as Premarket Approval Applications (PMAs).

⁴ House Committee on Energy and Commerce, “Food and Drug Administration Amendments Act of 2007,” H. Rept. 100-225, 110 th Congress, 1 st Session, on page 8.

Appendix A
Device Approvals and Review Times Report

¹ Although the disease or condition that the device treats, diagnoses or cures may exist in pediatric populations, most of the devices listed in the table are not specifically intended or labeled for pediatric use.

Updated April 28, 2009

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