80 FR 13864 - Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling; Guidance for Industry and Food and Drug Administration Staff; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 51 (March 17, 2015)

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.

[Federal Register Volume 80, Number 51 (Tuesday, March 17, 2015)]
[Notices]
[Pages 13864-13865]
From the Federal Register Online  [www.thefederalregister.org]
[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