Document ID: FDA-2008-D-0434-0012
Agency: fda
Document Type: Notice
Title: Guidance for Humanitarian Device Exemption Holders, et al.; Availability: Humanitarian Device Exemption Regulation; Questions and Answers
Posted Date: 2010-07-08T04:00Z

[Federal Register: July 8, 2010 (Volume 75, Number 130)]
[Notices]               
[Page 39263-39264]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08jy10-96]                         

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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 dsmica@fda.hhs.gov 
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]
BILLING CODE 4160-01-S