Document ID: FDA-2014-D-0223-0001
Agency: fda
Document Type: Notice
Title: Humanitarian Device Exemption: Questions and Answers; Draft
Guidance for Humanitarian Device Exemption Holders, Institutional
Review Boards, Clinical Investigators, and Food and Drug Administration
Staff; Availability
Posted Date: 2014-03-18T04:00Z

[Federal Register Volume 79, Number 52 (Tuesday, March 18, 2014)]
[Notices]
[Pages 15130-15131]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-05900]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0223]

Humanitarian Device Exemption: Questions and Answers; Draft 
Guidance for Humanitarian Device Exemption Holders, Institutional 
Review Boards, Clinical Investigators, and Food and Drug Administration 
Staff; 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availability of the draft guidance entitled ``Humanitarian Device 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): Questions and Answers.'' This draft guidance answers 
commonly asked questions about humanitarian use devices (HUDs) and HDE 
applications. This guidance document reflects changes to the HDE 
program as a result of the Food and Drug Administration Safety and 
Innovation Act (FDASIA). This draft guidance is not final nor is it in 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by June 16, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Humanitarian Device Exemption (HDE): 
Questions and Answers'' to the Division of Small Manufacturers, 
International and Consumer Assistance, 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 the 
Office of Communication, Outreach and Development (HFM-40), Center for 
Biologics Evaluation and Research (CBER), Food and Drug Administration, 
1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. Send one 
self-addressed adhesive label to assist that office in processing your 
request, or fax your request to 301-847-8149. See the SUPPLEMENTARY 
INFORMATION section for information on electronic access to the 
guidance.
    Submit electronic comments on the draft 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: Nicole Wolanski, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, rm. 1650, Silver Spring, MD 20993-0002, 301-
796-6570; or Stephen Ripley, Center for Biologics Evaluation and 
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, 
suite 200N, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION 

I. Background

    This draft guidance answers commonly asked questions about HUDs and 
HDE applications authorized under section 520(m) of the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(m)). Section 613 
of FDASIA (Pub. L. 112-144), signed into law on July 9, 2012, amended 
section 520(m) of the FD&C Act. This draft guidance document reflects 
the changes in the HDE program as a result of FDASIA. Upon issuance as 
a final guidance document, this guidance will replace the existing HDE 
guidance entitled ``Guidance for Humanitarian Device Exemption Holders, 
Institutional Review Boards, Clinical Investigators, and Food and Drug 
Administration Staff--Humanitarian Device Exemption Regulation: 
Questions and Answers,'' issued on July 8, 2010, which was developed 
and issued prior to the enactment of FDASIA.
    HUDs approved under an HDE cannot be sold for an amount that 
exceeds the costs of research and development, fabrication, and 
distribution of the device (i.e., for profit), except in certain 
circumstances. FDASIA expands the types of HDE-approved HUDs that are 
eligible to be sold for profit, subject to restrictions in section 
520(m)(6) of the FD&C Act.
    FDASIA also amends the definition of the annual distribution number 
(ADN). Under section 520(m)(6) of the FD&C Act, if FDA makes a 
determination that a HUD meets certain conditions, the HUD is permitted 
to be sold for profit after receiving HDE approval as long as the 
number of devices distributed in any

[[Page 15131]]

calendar year does not exceed the ADN that FDA determines for the 
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 commonly 
asked questions about HUDs and HDE applications. 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. 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 from CBER 
at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm.
    To receive ``Humanitarian Device Exemption (HDE): Questions and 
Answers,'' you may either send an email 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 
1816 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
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 sections 520(m) and 515A (21 U.S.C. 360e-
1) of the FD&C Act and 613(b) of FDASIA have been approved under OMB 
control number 0910-0661; 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 0910-0755; 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 either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). 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, and will be posted to the docket at http://www.regulations.gov.

    Dated: March 12, 2014.
Peter Lurie,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2014-05900 Filed 3-17-14; 8:45 am]
BILLING CODE 4160-01-P