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Federal Register: Guidance for Humanitarian Device Exemption Holders, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration Staff; Humanitarian...

Thu, 07/08/2010 - 7:31am
U.S. Food & Drug Administration

[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

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