[Federal Register Volume 76, Number 84 (Monday, May 2, 2011)]
[Notices]
[Pages 24494-24495]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-10516]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0293]
Draft Guidance for Industry and FDA Staff: Processing/
Reprocessing Medical Devices in Health Care Settings: Validation
Methods and Labeling; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the draft guidance document entitled ``Draft Guidance
for Industry and FDA Staff: Processing/Reprocessing Medical Devices in
Health Care Settings: Validation Methods and Labeling.'' The
recommendations in this guidance are intended to improve the safety and
effectiveness of devices with processing or reprocessing labeling. This
draft guidance is not final; nor is it in effect at this time.
DATES: Although you can comment on any guidance at any time (see Sec.
10.115 (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comment on this draft guidance before it begins work on the final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 electronic or written comments on the
draft guidance by August 1, 2011.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Draft Guidance for Industry and FDA Staff:
Processing/Reprocessing Medical Devices in Health Care Settings:
Validation Methods and Labeling'' to the Division of Small
Manufacturers, International, and Consumer Assistance, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002.
Send a fax request to 301-847-8149 to receive a hard copy.
Alternatively, you may submit written requests for single copies of the
draft guidance to the Office of Communication, Outreach and Development
(HFM-40), Center for Biologics Evaluation and Research, 1401 Rockville
Pike, suite 200N, Rockville, MD 20852. Send one self-addressed adhesive
label to the office that you are ordering from to assist in processing
your requests. See the SUPPLEMENTARY INFORMATION section for
information on electronic access to the guidance.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT:
Steven Turtil, Center for Devices and Radiological Health, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 1570,
Silver Spring, MD 20993-0002, 301-796-6305; 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
In recent years, there has been a significant advance in knowledge
and technology involved in reprocessing reusable medical devices.
Additionally, there has been an evolution towards more complex reusable
medical device designs that are more difficult to clean and disinfect
or sterilize. The revision of this guidance, originally published in
1996, reflects scientific advances in this area. Under FDA labeling
regulations (part 801 (21 CFR part 801)), a device must have adequate
directions for use, which include instructions on preparing a device
for use. Instructions on how to
[[Page 24495]]
reprocess (i.e., clean and disinfect or sterilize) a reusable device
are critical to ensuring a reusable device is appropriately prepared
for its next use.
II. Significance of Guidance
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (Sec. 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on processing
and reprocessing labeling for medical devices. 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 draft guidance may do
so by using the Internet. A search capability is available for all CDRH
guidance documents at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, and for CBER
guidance documents at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Guidance documents
are also available at http://www.regulations.gov. To receive ``Draft
Guidance for Industry and FDA Staff: Processing/Reprocessing Medical
Devices in Health Care Settings: Validation Methods and Labeling,'' you
may either send an email request to [email protected] 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 1748 to identify
the guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This draft 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 21 CFR part 807, subpart E are approved
under OMB control number 0910-0120; the collections of information in
part 801 are approved under OMB control number 0910-0485; and the
collections of information in 21 CFR part 812 are approved under OMB
control number 0910-0078.
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: April 26, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-10516 Filed 4-29-11; 8:45 am]
BILLING CODE 4160-01-P