Document ID: FDA-2011-D-0293-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling; Availability
Posted Date: 2011-05-02T04:00Z

[Federal Register Volume 76, Number 84 (Monday, May 2, 2011)]
[Notices]
[Pages 24494-24495]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-10516]

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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Draft Guidance for Industry and FDA Staff: Processing/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.

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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availability of the draft guidance document entitled ``Draft Guidance 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draft guidance is not final; nor is it in effect at this time.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comment on this draft guidance before it begins work on the final 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draft guidance by August 1, 2011.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Draft Guidance for Industry and FDA Staff: 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draft guidance to the Office of Communication, Outreach and Development 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 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 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