[Federal Register Volume 80, Number 51 (Tuesday, March 17, 2015)]
[Notices]
[Pages 13864-13865]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-06029]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0293]
Reprocessing Medical Devices in Health Care Settings: Validation
Methods and Labeling; Guidance for Industry and Food and Drug
Administration Staff; 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 guidance entitled ``Reprocessing Medical Devices in
Health Care Settings: Validation Methods and Labeling.'' This guidance
provides recommendations for the formulation and scientific validation
of reprocessing instructions for reusable medical devices. This
guidance document also provides recommendations for the content and
review procedures for premarket notification (510(k)) submissions,
premarket approval (PMA) applications, humanitarian device exemption
(HDE) applications, de novo requests, and investigational device
exemption (IDE) applications, concerning the labeling instructions for
reprocessing reusable medical devices. This guidance reflects the
scientific advances in knowledge and technology involved in
reprocessing reusable medical devices, especially more complex,
reusable medical device designs that are more difficult to reprocess.
DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.
ADDRESSES: An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Reprocessing Medical Devices in Health Care Settings: Validation
Methods and Labeling'' to the Office of the Center Director, Guidance
and Policy Development, Center for Devices and Radiological Health,
Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 66, Rm.
5431, Silver Spring, MD 20993-0002; or the Office of Communication,
Outreach and Development, Center for Biologics Evaluation and Research
(CBER), Food and Drug Administration, 10903 New Hampshire Ave. Bldg.
71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your request.
Submit electronic comments on the 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: Angela C. Krueger, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1666, Silver Spring, MD 20993-0002, 301-
796-6380; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg.
71, Rm. 7301, Silver Spring, MD 20993, 240-402-7911.
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 medical
device designs that are more difficult to clean, disinfect, and
sterilize. This guidance reflects the scientific advances in these
areas. Under section 502(f) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 352(f)), a device must have adequate directions for use,
which include instructions on preparing a device for use. Instructions
on how to reprocess (i.e., clean, disinfect, and sterilize) a reusable
device are critical to ensure that the device is appropriately prepared
for its next use.
In the Federal Register of May 2, 2011 (76 FR 24494), FDA announced
the availability of the draft guidance. Interested persons were invited
to comment by August 1, 2011. FDA reviewed and considered all the
public comments we received and revised several sections of the
guidance, where applicable. On June 8 and 9, 2011, FDA held a public
workshop entitled ``Reprocessing of Reusable Medical Devices
Workshop.'' The purpose of the workshop was to discuss factors
affecting the reprocessing of reusable medical devices and FDA's plans
to address the identified issues. The discussion during this workshop
and the comments received were considered before revising the guidance.
This final guidance supersedes ``Labeling Reusable
[[Page 13865]]
Medical Devices for Reprocessing in Health Care Facilities: FDA
Reviewer Guidance'' dated April 1996.
This final guidance contains the addition of ``Appendix E: Devices
for which a 510(k) Should Contain Data to Validate Reprocessing
Instructions,'' which includes a subset of medical devices that FDA has
identified that pose a greater likelihood of microbial transmission and
represent a high risk of infection if they are not adequately
reprocessed. Because of this greater public health risk, 510(k)
submissions for these devices should include protocols and complete
test reports of the validation of the reprocessing instructions so that
FDA has the information it needs to evaluate substantial equivalence.
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on reprocessing validation methods and
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 guidance may do so by
using the Internet. A search capability for all CDRH guidance documents
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov. Persons unable to
download an electronic copy of ``Reprocessing Medical Devices in Health
Care Settings: Validation Methods and Labeling'' may send an email
request to [email protected] to receive an electronic copy of
the document. Please use the document number 1748 to identify the
guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
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 parts 801 and 809 have been
approved under OMB control number 0910-0485 (medical device labeling);
the collections of information in 21 CFR part 807, subpart E have been
approved under OMB control number 0910-0120 (premarket notification);
the collections of information in 21 CFR part 812 have been approved
under OMB control number 0910-0078 (investigational device exemption);
the collections of information in 21 CFR part 814, subparts A through E
have been approved under OMB control number 0910-0231 (premarket
approval); the collections of information in 21 CFR part 814, subpart H
have been approved under OMB control number 0910-0332 (humanitarian use
devices); and the collections of information in 21 CFR part 820 have
been approved under OMB control number 0910-0073 (quality system
regulation).
V. Comments
Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of 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, and will be posted to the docket at http://www.regulations.gov.
Dated: March 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-06029 Filed 3-16-15; 8:45 am]
BILLING CODE 4164-01-P