[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Draft Guidance for Industry and Food and Drug Administration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availability of a draft guidance for industry and FDA staff entitled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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by March 12, 2012.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Orphan Products Development (OOPD), Food and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INFORMATION section for electronic access to the draft guidance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Submit electronic comments on the draft guidance to http://www.regulations.gov.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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