[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Draft Guidance for Industry and Food and Drug Administration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availability of the draft guidance entitled ``Hospital Bed System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 This draft guidance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DATES: Submit written or electronic comments on this draft guidance by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diskette of the draft guidance document entitled ``Hospital Bed System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Submit written comments concerning this draft guidance to the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This draft guidance identifies special issues associated with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]
BILLING CODE 4160-01-S