[Federal Register: August 30, 2004 (Volume 69, Number 167)]
[Notices]               
[Page 52907]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30au04-61]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0343]

 
Draft Guidance for Industry and Food and Drug Administration 
Staff; Hospital Bed System Dimensional Guidance to Reduce Entrapment; 
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availability of the draft guidance entitled ``Hospital Bed System 
Dimensional Guidance to Reduce Entrapment.'' This draft guidance 
provides recommendations intended to reduce life-threatening 
entrapments associated with hospital bed systems. It characterizes the 
body parts at risk for entrapment, identifies the locations of hospital 
bed openings that are potential entrapment areas, and recommends 
dimensional criteria for bed systems.

DATES:  Submit written or electronic comments on this draft guidance by 
November 29, 2004.

ADDRESSES:  Submit written requests for single copies on a 3.5'' 
diskette of the draft guidance document entitled ``Hospital Bed System 
Dimensional Guidance to Reduce Entrapment'' 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 301-443-8818. See the SUPPLEMENTARY INFORMATION section for 
information on electronic access to the guidance.
    Submit written comments concerning this draft guidance to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic 
comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Identify comments 

with the docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Jay A. Rachlin, Center for Devices and 
Radiological Health (HFZ-230), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-594-3173.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance identifies special issues associated with 
hospital bed systems and provides recommendations intended to reduce 
life-threatening entrapments associated with these devices. 
Manufacturers may use this guidance to assess current hospital bed 
systems and to assist in the design of new beds.

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 appropriate 
dimensional limits for gaps in hospital bed systems to prevent 
entrapment. 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

    To receive the ``Hospital Bed System Dimensional Guidance to Reduce 
Entrapment'' you may either send a fax request to 301-443-8818 to 
receive a hard copy of the document, or send an e-mail request to 
GWA@CDRH.FDA.GOV to receive a hard copy or an electronic copy. Please 

use the document number 1537 to identify the guidance you are 
requesting.
    Persons interested in obtaining a copy of the draft guidance may 
also do so by using the Internet. 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh A search capability for all CDRH guidance documents is available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html.
 Guidance documents are also available on the Division of 

Dockets Management Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets.


IV. 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 
copy. Received comments are to be identified with the docket number 
found in brackets in the heading of this document. Comments received 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday.

    Dated: August 11, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-19656 Filed 8-27-04; 8:45 am]

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