Document ID: FDA-2008-D-0434-0001
Agency: fda
Document Type: Notice
Title: Humanitarian Device Exemption Regulation: Draft Guidance for Exemption Holders, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration Staff; Questions and Answers
Posted Date: 2008-08-05T04:00Z

[Federal Register: August 5, 2008 (Volume 73, Number 151)]
[Notices]               
[Page 45460-45462]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05au08-67]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0434]

 
Draft Guidance for Humanitarian Device Exemption Holders, 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availability of the draft guidance entitled ``Humanitarian Device 
Exemption (HDE) Regulation: Questions and Answers.'' This draft 
guidance answers commonly asked questions about Humanitarian Use 
Devices (HUDs) and applications for HDE. This draft guidance is neither 
final nor is it in effect at this time.

DATES:  Although you can comment on any guidance at any time (see 21 
CFR 10.115 (g)(5)), to ensure that the agency considers your comment on 
this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by November 3, 2008.

ADDRESSES:  Submit written requests for single copies of the draft 
guidance document entitled ``Humanitarian Device Exemption (HDE) 
Regulation: Questions and Answers'' to the Division of Small 
Manufacturers, International, and Consumer Assistance (HFZ-220), Center 
for Devices and Radiological Health, Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive 
label to assist that office in processing your request, or fax your 
request to 240-276-3151. See the SUPPLEMENTARY INFORMATION section for 
information on electronic access to the guidance.
    Submit written comments concerning this draft guidance to the 
Division of

[[Page 45461]]

Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.regulations.gov. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Stephen P. Rhodes, Center for Devices 
and Radiological Health (HFZ-403), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 240-276-4036.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft 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 the 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 515A(a)(2) of the act). 
It also amends section 520(m) of the act (21 U.S.C. 360j(m)) 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 includes 30 
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.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on the aspects 
of HDE regulation discussed in the guidance. 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 draft guidance may do 
so by using the Internet. To receive ``Humanitarian Device Exemption 
(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 240-276-3151 to receive a hard copy. 
Please use the document number 1666 to identify the guidance you are 
requesting.
    CDRH maintains an entry on the Internet for easy access to 
information including text, graphics, and files that may be downloaded 
to a personal computer with Internet access. Updated on a regular 
basis, the CDRH home page includes device safety alerts, Federal 
Register reprints, information on premarket submissions (including 
lists of approved applications and manufacturers' addresses), small 
manufacturer's assistance, information on video conferencing and 
electronic submissions, Mammography Matters, and other device-oriented 
information. The CDRH Web site may be accessed at http://www.fda.gov/
cdrh. A search capability for all CDRH guidance documents is available 
at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also 
available at http://www.regulations.gov.

IV. Paperwork Reduction Act of 1995

    Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 
3501-3520), Federal agencies must obtain approval from the Office of 
Management and Budget (OMB) for each collection of information they 
conduct or sponsor. ``Collection of information'' is defined in 44 
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or 
requirements that members of the public submit reports, keep records, 
or provide information to a third party. Section 3506(c)(2)(A) of the 
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 
60-day notice in the Federal Register concerning each proposed 
collection of information before submitting the collection to OMB for 
approval. To comply with this requirement, FDA is publishing notice of 
the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.
    Title: Pediatric Use Information to Accompany Humanitarian Device 
Exemption Applications.
    Description: Title III of the Food and Drug Administration 
Amendments Act of 2007 (FDAAA) (Public Law 110-85) amended chapter V of 
the act (21 U.S.C. 351 et seq.) by inserting section 515A Pediatric 
Uses of Devices (21 U.S.C. 360e-1).
    This new provision requires that new applications under section 
520(m) of the act 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.
    Title III of FDAAA also amended section 520(m) of the act as 
follows:
     Section 520(m)(6)(A)(ii) provides that the Secretary of 
Health and Human Services will assign an annual distribution number for 
devices indicated for use in pediatric patients or in a pediatric 
subpopulation. The ADN shall be based on the following information in 
an HDE application: (1) the number of individuals affected by the 
disease or condition that such device is intended to treat, diagnose, 
or cure, and of that number; (2) the number of individuals likely to 
use the device; and (3) the number of devices reasonably necessary to 
treat such individuals.
     Section 520(m)(6)(A)(iii) provides that an HDE holder 
immediately notify the agency if the number of devices distributed 
during any calendar year exceeds the annual distribution number.
     Section 520(m)(6)(C) provides that an HDE holder may 
petition to modify the annual distribution number if additional 
information on the number of individuals affected by the disease or 
condition arises.
    The proposed collections of information are necessary to satisfy 
the previously mentioned statutory requirements.
    Respondents to this collection of information are holders of HDEs

[[Page 45462]]

indicated for use in pediatric patients or in a pediatric subpopulation 
that were approved on or after September, 27, 2007, the enactment date 
of the Pediatric Medical Device Safety and Improvement Act of 2007.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Section of the
 Federal Food,        No. of         Annual Frequency    Total Annual  HDE      Hours per
   Drug, and        Applicants         per Response         Applications         Response         Total Hours
 Cosmetic Act
----------------------------------------------------------------------------------------------------------------
515A(a)(2)                      5                     1                  5                100                500
----------------------------------------------------------------------------------------------------------------
520(m)(6)(A)(i                  3                     1                  3                 50                150
 i)
----------------------------------------------------------------------------------------------------------------
520(m)(6)(A)(i                  1                     1                  1                100                100
 ii)
----------------------------------------------------------------------------------------------------------------
520(m)(6)(C)                    5                     1                  5                100                500
----------------------------------------------------------------------------------------------------------------
Total                                                                                                      1,250
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA based these estimates on the number of original HDE 
applications that the Center for Devices and Radiological Health (CDRH) 
received in the period between October 1, 2004, and September 30, 2007. 
During that time, CDRH received 16 original HDE applications or about 5 
per year.
    FDA estimates that for each year CDRH will receive five HDE 
applications and that three of these applications will be indicated for 
pediatric use. One HDE holder will notify the agency that the number of 
devices distributed in the year has exceeded the annual distribution 
number and five HDE holders will petition to have the annual 
distribution number modified due to additional information on the 
number of individuals affected by the disease or condition.
    This draft guidance also refers to previously approved collections 
of information found in FDA regulations. The collections of information 
in 21 CFR part 803 have been approved under OMB control number 0910-
0437; the collections of information in 21 CFR part 812 have been 
approved under OMB control number 0910-0078; the collections of 
information in 21 CFR part 807, subpart E have been approved under OMB 
control number 0910-0120; the collections of information in 21 CFR part 
814, subparts A, B, and C have been approved under OMB control number 
0910-0231; the collections of information in 21 CFR parts 50 and 56 
have been approved under OMB control number 0910-0130; the collections 
of information in 21 CFR part 820 have been approved under OMB control 
number 0910-0073; the collections of information in 21 CFR part 814, 
subpart H have been approved under OMB control number 0910-0332; and 
the collections of information in 21 CFR 10.30 have been approved under 
OMB control number 0910-0183.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), written or electronic comments regarding this 
document. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Comments are to be identified 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.
     Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

    Dated: July 30, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-17905 Filed 8-4-08; 8:45 am]

BILLING CODE 4160-01-S