[Federal Register Volume 76, Number 239 (Tuesday, December 13, 2011)]
[Notices]
[Pages 77542-77543]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-31867]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0847]


Draft Guidance for Industry and Food and Drug Administration 
Staff on Humanitarian Use Device Designations; 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availability of a draft guidance for industry and FDA staff entitled 
``Humanitarian Use Device (HUD) Designations.'' Devices are eligible 
for HUD designation if they are designed to treat or diagnose a disease 
or condition that affects or is manifested in fewer than 4,000 
individuals in the United States per year. Devices that receive HUD 
designation may be eligible for marketing approval under the 
Humanitarian Device Exemption (HDE) marketing pathway. This guidance 
document is intended to assist applicants in the preparation and 
submission of HUD designation requests and FDA reviewers in evaluating 
such requests.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by March 12, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Orphan Products Development (OOPD), Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5271, 
Silver Spring, MD 20993. Send one self-addressed adhesive label to 
assist that office in processing your requests. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 
document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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.

FOR FURTHER INFORMATION CONTACT: Eric Chen, Office of Orphan Products 
Development, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 32, Rm. 5271, Silver Spring, MD 20993, (301) 796-8660.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
and FDA staff entitled ``Humanitarian Use Device (HUD) Designations.'' 
Devices are eligible for HUD designation if they are designed to treat 
or diagnose a disease or condition that affects or is manifested in 
fewer than 4,000 individuals in the United States per year. (See 
section 520(m) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
(21 U.S.C. 360j(m)); 21 CFR 814.102). This guidance document is 
intended to assist applicants in the preparation and submission of HUD 
designation requests to FDA, OOPD. This guidance is also intended to 
assist FDA reviewers in the evaluation and analysis of HUD designation 
requests.
    Topics addressed in this guidance include: (1) Demonstrating in HUD 
requests that the device is designed to treat or diagnose a disease or 
condition that affects or is manifested in fewer than 4,000 individuals 
in the United States per year; (2) how this demonstration varies, 
depending on whether the device is intended for therapeutic or 
diagnostic purposes; (3) how properties of the device may affect this 
demonstration; and (4) delineating a medically plausible subset of 
persons with a given disease or condition.
    Devices that receive HUD designation may be eligible for marketing 
approval under an HDE application. An HDE application is a premarketing 
application that is similar to a premarket approval (PMA) application 
in that the applicant must demonstrate a reasonable assurance of 
safety, but in an HDE application, the applicant seeks an exemption 
from the PMA requirement to demonstrate a reasonable assurance of 
effectiveness. A device is eligible for HDE approval if, among other 
criteria, the probable benefit to health from use of the device 
outweighs the risk of injury or illness from its use, taking into 
account the probable risks and benefits of currently available devices 
or alternative forms of treatment. (See section 520(m) of the FD&C Act; 
21 CFR 814.104(b)(2)). Although a HUD designation is a prerequisite to 
submitting an HDE application, it is only one of many required elements 
of the application (21 CFR 814.104). Receipt of a HUD designation does 
not guarantee that the HDE marketing application will be approved.
    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 humanitarian 
use device designations. 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 statutes and regulations.

II. 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 21 CFR part 814, subpart H, have been 
approved under OMB control number 0910-0332.

III. 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

[[Page 77543]]

of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/RegulatoryInformation/Guidances/default.htm 
or http://www.regulations.gov.

    Dated: December 7, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-31867 Filed 12-12-11; 8:45 am]
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