[Federal Register Volume 75, Number 130 (Thursday, July 8, 2010)]
[Notices]
[Pages 39263-39264]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-16548]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0434]
Guidance for Humanitarian Device Exemption Holders, Institutional
Review Boards, Clinical Investigators, and Food and Drug Administration
Staff; Humanitarian Device Exemption Regulation; Questions and Answers;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``Humanitarian Device Exemption
(HDE) Regulation: Questions and Answers.'' This guidance answers
commonly asked questions about Humanitarian Use Devices (HUDs) and
applications for HDEs.
DATES: Submit either electronic or written comments on this guidance
at any time. General comments on agency guidance documents are welcome
at any time.
ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Humanitarian Device Exemption (HDE) Regulation:
Questions and Answers'' to the Division of Small Manufacturers,
International, and Consumer Assistance (DSMICA), Center for Devices and
Radiological Health (CDRH), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg.66, rm. 4613, Silver Spring, MD 20993-0002 or to
the Office of Communication, Outreach and Development (HFM-40), Center
for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. Send one
self-addressed adhesive label to assist that office in processing your
request, or fax your request to CDRH at 301-847-8149. The guidance may
also be obtained by mail by calling CBER at 1-800-835-4709 or 301-827-
1800. See the SUPPLEMENTARY INFORMATION section for information on
electronic access to the guidance.
Submit electronic comments on the guidance 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. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Sheila Brown, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 1651, Silver Spring, MD 20993-0002, 301-796-6563,
or Stephen Ripley, Center for Biologics Evaluation and Research (HFM-
17), Food and Drug Administration, 1401 Rockville Pike, suite 200N,
Rockville, MD 20852, 301-827-6210.
SUPPLEMENTARY INFORMATION:
I. Background
This guidance answers commonly asked questions about HUDs and
applications for HDE authorized by section 510(m)(2) of the Federal
Food, Drug and Cosmetic Act (the act) (21 U.S.C. 360(m)(2)). This
update of the version issued in 2006 reflects additional requirements
set forth in the Pediatric Medical Device Safety and Improvement Act of
2007 (Public Law 110-85). The Pediatric Medical Device Safety and
Improvement Act of 2007 includes a provision requiring that all
original HDE applications include both 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 (new section 515A(a)(2) of the act). It
also amends section 520(m) of the act to exempt some HUDs from the
prohibition on profit (new section 520(m)(6) of the act). Specifically,
HDE applications indicated for use in pediatric patients that are
approved on or after September 27, 2007, may be assigned an annual
distribution number (ADN) and be sold for profit, subject to certain
restrictions. Finally, the Pediatric Medical Device Safety and
Improvement Act of 2007 includes a provision requiring that the agency
provide guidance to Institutional Review Boards (IRBs) on the review of
HUDs. This update of the HDE guidance
[[Page 39264]]
includes 29 specific questions and answers for IRBs as well as guidance
to HDE holders on whether and how they may become eligible to receive
profit from the sale of their device. In the Federal Register of August
5, 2008 (73 FR 45460), FDA published a 60-day notice requesting public
comment. The comment period closed on November 3, 2008. FDA published a
30-day notice on September 30, 2009 (74 FR 50214), but republished a
30-day notice on February 18, 2010 (75 FR 7270), to provide a more
descriptive response to the comments received in response to the August
5, 2008, notice. This document supersedes: Humanitarian Device
Exemption (HDE) Regulation: Questions and Answers, issued July 18,
2006.
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on the ``HDE Regulation: Questions and
Answers.'' It does not create or confer any rights for or on any person
and does not operate to bind FDA or the public. An alternative approach
may be used if such approach satisfies the requirements of the
applicable statute and regulations.
III. Electronic Access
Persons interested in obtaining a copy of the guidance may do so by
using the Internet. To receive ``HDE Regulation: Questions and
Answers,'' you may either send an e-mail request to [email protected]
to receive an electronic copy of the document or send a fax request to
301-847-8149 to receive a hard copy. Please use the document number
1668 to identify the guidance you are requesting. A search capability
for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at http://www.regulations.gov or the CBER Internet site at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
IV. Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in this guidance were approved under OMB
control number 0910-0661, May 31, 2013, expiration date.
V. 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. It is no
longer necessary to send two copies of mailed 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: July 1, 2010.
Nancy Stade,
Acting Associate Director for Regulations and Policy, Center for
Devices and Radiological Health.
[FR Doc. 2010-16548 Filed 7-7-10; 8:45 am]
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