[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