[Federal Register Volume 77, Number 16 (Wednesday, January 25, 2012)]
[Notices]
[Pages 3781-3782]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-1443]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0754]


Pediatric Medical Devices; Public Workshop; Reopening of Comment 
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening until 
March 5, 2012, the comment period for the notice entitled ``Pediatric 
Medical Devices; Public Workshop; Request for Comments'' that appeared 
in the Federal Register of Tuesday, November 1, 2011 (76 FR 67463). In 
the notice, FDA announced a public workshop to consider factors 
affecting the use of scientific research data to support pediatric 
medical device efficacy claims. This is part of an on-going effort to 
address the ways scientific research data can be used to support 
pediatric effectiveness claims for medical devices and pediatric device 
approvals or clearance; the scientific and regulatory limitations and 
issues of using existing scientific research data to support pediatric 
effectiveness claims and pediatric indication approvals for medical 
devices; and methods to overcome the pitfalls and data gaps, including 
statistical approaches and modeling. The agency is taking this action 
to allow interested persons additional time to submit comments on the 
use of scientific research data, including published scientific 
literature, to support and establish pediatric indications for medical 
devices.

DATES: Submit either electronic or written comments by March 5, 2012.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Carol Krueger, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5437, Silver Spring, MD 20993-0002, (301) 796-3241, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In 2007, Congress passed the Pediatric Medical Device Safety and 
Improvement

[[Page 3782]]

Act (the Act). The Act addresses pediatric device needs by providing 
financial incentives for development, production, approval and 
distribution of new devices for rare and unmet pediatric needs; 
allowing for a pediatric device approval pathway that permits 
extrapolation of adult effectiveness data to support a pediatric 
indication based on similar course of the disease or condition or a 
similar effect of the device; and providing grants to pediatric device 
consortia that provide technical support and assistance to pediatric 
device innovators.
    FDA held a public workshop on December 5, 2011, to support FDA's 
efforts to define pathways for approving pediatric device indications 
by leveraging available scientific research data. An important, but not 
the only, focus was a discussion of how to determine when it is 
appropriate to use, and how to use, existing scientific research data 
to determine pediatric effectiveness based on a similar course of a 
disease or condition or a similar effect of a device on adults and 
similar extrapolation between pediatric subpopulations.
    The demand by health care professionals and consumers for safe and 
effective pediatric medical devices continues to steadily increase. 
Pediatric medical devices treat or diagnose diseases and conditions 
occurring from birth through the 21st year of life. Some devices are 
designed specifically for pediatric use, while others are adopted from 
specific adult device applications or produced for more general use.
    Designing pediatric medical devices can be challenging; children 
are often smaller and more active than adults; body structures and 
functions change throughout childhood, and children may be long-term 
device users--bringing new concerns about device longevity and long-
term exposure to implanted materials. The current medical device market 
for children has a higher demand than supply. FDA is committed to 
supporting the development and availability of safe and effective 
pediatric medical devices.
    Regardless of attendance at the public workshop, interested persons 
may submit either electronic or written comments on the topics 
discussed at the Public Workshop.

II. Topics Discussed at the Public Workshop

    The public workshop discussed the following topic areas:
    1. The use of existing scientific research data to support 
pediatric effectiveness claims for medical devices and pediatric device 
approvals or clearance,
    2. The scientific and regulatory limitations and issues with the 
use of existing scientific research data, and
    3. The methods to overcome the pitfalls and data gaps, including 
statistical approaches and modeling.

III. Transcripts

    Please be advised that a transcript of the public workshop is 
available at http://www.regulations.gov at FDA docket number FDA-2011-
N-0754. The transcript may be viewed at the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. A transcript is also available online at 
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm278053.htm.

IV. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: January 19, 2012.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2012-1443 Filed 1-24-12; 8:45 am]
BILLING CODE 4160-01-P