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Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling; Availability

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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The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled “Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.”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 This draft guidance is not final; nor is it in effect at this time.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any guidance at any time (see § 10.115 (21 CFR 10.115(g)(5))), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit electronic or written comments on the draft guidance by August 1, 2011.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Submit written requests for single copies of the draft guidance document entitled “Draft Guidance for Industry and FDA Staff: Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” to the Division of Small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 Alternatively, you may submit written requests for single copies of the draft guidance to the Office of Communication, Outreach and Development (HFM-40), Center for Biologics Evaluation and Research, 1401 Rockville Pike, suite 200N, Rockville, MD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Submit electronic comments on the draft guidance to http://www.regulations.gov.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.

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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.

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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 Start Printed Page 24495reprocess (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 (§ 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.

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Dated: April 26, 2011.

Nancy K. Stade,

Deputy Director for Policy, Center for Devices and Radiological Health.

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[FR Doc. 2011-10516 Filed 4-29-11; 8:45 am]

BILLING CODE 4160-01-P