80_FR_13915 80 FR 13864 - Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling; Guidance for Industry and Food and Drug Administration Staff; Availability

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)

Page Range13864-13865
FR Document2015-06029

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 Issue 51 (Tuesday, March 17, 2015) 
[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 CDRH-Guidance@fda.hhs.gov 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

13864 Federal Register / Vol. 80, No. 51 / Tuesday, March 17, 2015 / Notices Name of Committee: Center for Scientific DEPARTMENT OF HEALTH AND 10903 New Hampshire Ave. Bldg. 71, Review Special Emphasis Panel; AIDS and HUMAN SERVICES Rm. 3128, Silver Spring, MD 20993– AIDS Related Research. 0002. Send one self-addressed adhesive Date: March 18, 2015. Food and Drug Administration label to assist that office in processing Time: 11:00 a.m. to 5:00 p.m. [Docket No. FDA–2011–D–0293] your request. Agenda: To review and evaluate grant applications. Submit electronic comments on the Place: National Institutes of Health, 6701 Reprocessing Medical Devices in guidance to http://www.regulations.gov. Rockledge Drive, Bethesda, MD 20892, Health Care Settings: Validation Submit written comments to the (Telephone Conference Call). Methods and Labeling; Guidance for Division of Dockets Management (HFA– Contact Person: Jose H Guerrier, Ph.D., Industry and Food and Drug 305), Food and Drug Administration, Scientific Review Officer, Center for Administration Staff; Availability 5630 Fishers Lane, Rm. 1061, Rockville, Scientific Review, National Institutes of MD 20852. Identify comments with the Health, 6701 Rockledge Drive, Room 5218, AGENCY: Food and Drug Administration, docket number found in brackets in the MSC 7852, Bethesda, MD 20892, 301–435– HHS. heading of this document. 1137, guerriej@csr.nih.gov. ACTION: Notice. FOR FURTHER INFORMATION CONTACT: This notice is being published less than 15 Angela C. Krueger, Center for Devices days prior to the meeting due to the timing SUMMARY: The Food and Drug limitations imposed by the review and and Radiological Health, Food and Drug Administration (FDA) is announcing the funding cycle. Administration, 10903 New Hampshire availability of the guidance entitled Name of Committee: Center for Scientific Ave., Bldg. 66, Rm. 1666, Silver Spring, ‘‘Reprocessing Medical Devices in Review Special Emphasis Panel; Small MD 20993–0002, 301–796–6380; or Health Care Settings: Validation Business: Respiratory Sciences Special Panel. Stephen Ripley, Center for Biologics Methods and Labeling.’’ This guidance Date: March 19–20, 2015. Evaluation and Research, Food and Time: 9:00 a.m. to 5:00 p.m. provides recommendations for the Drug Administration, 10903 New Agenda: To review and evaluate grant formulation and scientific validation of Hampshire Ave. Bldg. 71, Rm. 7301, applications. reprocessing instructions for reusable Silver Spring, MD 20993, 240–402– Place: National Institutes of Health, One medical devices. This guidance 7911. Democracy Plaza, 6701 Democracy document also provides Boulevard, Bethesda, MD 20892, (Virtual recommendations for the content and SUPPLEMENTARY INFORMATION: Meeting). review procedures for premarket Contact Person: Lawrence E Boerboom, I. Background notification (510(k)) submissions, Ph.D., Chief, CVRS IRG, Center for Scientific premarket approval (PMA) applications, In recent years, there has been a Review, National Institutes of Health, 6701 significant advance in knowledge and Rockledge Drive, Room 4130, MSC 7814, humanitarian device exemption (HDE) applications, de novo requests, and technology involved in reprocessing Bethesda, MD 20892, (301) 435–8367, reusable medical devices. Additionally, boerboom@nih.gov. investigational device exemption (IDE) applications, concerning the labeling there has been an evolution towards This notice is being published less than 15 more complex medical device designs days prior to the meeting due to the timing instructions for reprocessing reusable medical devices. This guidance reflects that are more difficult to clean, limitations imposed by the review and funding cycle. the scientific advances in knowledge disinfect, and sterilize. This guidance Name of Committee: Center for Scientific and technology involved in reprocessing reflects the scientific advances in these Review Special Emphasis Panel; Member reusable medical devices, especially areas. Under section 502(f) of the Conflict: Respiratory Sciences Special Panel. more complex, reusable medical device Federal Food, Drug, and Cosmetic Act Date: March 24–25, 2015. designs that are more difficult to (21 U.S.C. 352(f)), a device must have Time: 9:00 a.m. to 5:00 p.m. reprocess. adequate directions for use, which Agenda: To review and evaluate grant include instructions on preparing a applications. DATES: Submit either electronic or device for use. Instructions on how to Place: National Institutes of Health, 6701 written comments on this guidance at reprocess (i.e., clean, disinfect, and Rockledge Drive, Bethesda, MD 20892, any time. General comments on Agency sterilize) a reusable device are critical to (Virtual Meeting). guidance documents are welcome at any Contact Person: Lawrence E Boerboom, ensure that the device is appropriately time. prepared for its next use. Ph.D., Chief, CVRS IRG, Center for Scientific Review, National Institutes of Health, 6701 ADDRESSES: An electronic copy of the In the Federal Register of May 2, 2011 Rockledge Drive, Room 4130, MSC 7814, guidance document is available for (76 FR 24494), FDA announced the Bethesda, MD 20892, (301) 435–8367, download from the Internet. See the availability of the draft guidance. boerboom@nih.gov. SUPPLEMENTARY INFORMATION section for Interested persons were invited to This notice is being published less than 15 information on electronic access to the comment by August 1, 2011. FDA days prior to the meeting due to the timing guidance. Submit written requests for a reviewed and considered all the public limitations imposed by the review and single hard copy of the guidance comments we received and revised funding cycle. document entitled ‘‘Reprocessing several sections of the guidance, where (Catalogue of Federal Domestic Assistance Medical Devices in Health Care Settings: applicable. On June 8 and 9, 2011, FDA Program Nos. 93.306, Comparative Medicine; Validation Methods and Labeling’’ to held a public workshop entitled 93.333, Clinical Research, 93.306, 93.333, the Office of the Center Director, ‘‘Reprocessing of Reusable Medical 93.337, 93.393–93.396, 93.837–93.844, Guidance and Policy Development, Devices Workshop.’’ The purpose of the 93.846–93.878, 93.892, 93.893, National mstockstill on DSK4VPTVN1PROD with NOTICES Institutes of Health, HHS) Center for Devices and Radiological workshop was to discuss factors Health, Food and Drug Administration, affecting the reprocessing of reusable Dated: March 11, 2015. 10903 New Hampshire Ave. Bldg. 66, medical devices and FDA’s plans to David Clary, Rm. 5431, Silver Spring, MD 20993– address the identified issues. The Program Analyst, Office of Federal Advisory 0002; or the Office of Communication, discussion during this workshop and Committee Policy. Outreach and Development, Center for the comments received were considered [FR Doc. 2015–06036 Filed 3–16–15; 8:45 am] Biologics Evaluation and Research before revising the guidance. This final BILLING CODE 4140–01–P (CBER), Food and Drug Administration, guidance supersedes ‘‘Labeling Reusable VerDate Sep<11>2014 18:09 Mar 16, 2015 Jkt 235001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.SGM 17MRN1

Federal Register / Vol. 80, No. 51 / Tuesday, March 17, 2015 / Notices 13865 Medical Devices for Reprocessing in 3520). The collections of information in and Budget (OMB) for review and Health Care Facilities: FDA Reviewer 21 CFR parts 801 and 809 have been approval. Guidance’’ dated April 1996. approved under OMB control number Written comments and/or suggestions This final guidance contains the 0910–0485 (medical device labeling); from the public and affected agencies addition of ‘‘Appendix E: Devices for the collections of information in 21 CFR are invited on one or more of the which a 510(k) Should Contain Data to part 807, subpart E have been approved following points: (1) Whether the Validate Reprocessing Instructions,’’ under OMB control number 0910–0120 proposed collection of information is which includes a subset of medical (premarket notification); the collections necessary for the proper performance of devices that FDA has identified that of information in 21 CFR part 812 have the function of the agency, including pose a greater likelihood of microbial been approved under OMB control whether the information will have transmission and represent a high risk number 0910–0078 (investigational practical utility; (2) The accuracy of the of infection if they are not adequately device exemption); the collections of agency’s estimate of the burden of the reprocessed. Because of this greater information in 21 CFR part 814, proposed collection of information, public health risk, 510(k) submissions subparts A through E have been including the validity of the for these devices should include approved under OMB control number methodology and assumptions used; (3) protocols and complete test reports of 0910–0231 (premarket approval); the Ways to enhance the quality, utility, and the validation of the reprocessing collections of information in 21 CFR clarity of the information to be instructions so that FDA has the part 814, subpart H have been approved collected; and (4) Ways to minimize the information it needs to evaluate under OMB control number 0910–0332 burden of the collection of information substantial equivalence. (humanitarian use devices); and the on those who are to respond, including collections of information in 21 CFR the use of appropriate automated, II. Significance of Guidance electronic, mechanical, or other part 820 have been approved under This guidance is being issued OMB control number 0910–0073 technological collection techniques or consistent with FDA’s good guidance (quality system regulation). other forms of information technology. practices regulation (21 CFR 10.115). To Submit Comments And For The guidance represents the Agency’s V. Comments Further Information: To obtain a copy of current thinking on reprocessing Interested persons may submit either the data collection plans and validation methods and labeling for electronic comments regarding this instruments, submit comments in medical devices. It does not create or document to http://www.regulations.gov writing, or request more information on confer any rights for or on any person or written comments to the Division of the proposed project, contact: Carla L. and does not operate to bind FDA or the Dockets Management (see ADDRESSES). It Easter, Ph.D., Chief, Education and public. An alternative approach may be is only necessary to send one set of Community Involvement Branch, used if such approach satisfies the comments. Identify comments with the NHGRI, Building 31, Room B1B55, 31 requirements of the applicable statute docket number found in brackets in the Center Drive, MSC 2070, Bethesda, MD and regulations. heading of this document. Received 20892 or call non-toll-free number (301) comments may be seen in the Division 594–1364 or Email your request, III. Electronic Access including your address to: easterc@ of Dockets Management between 9 a.m. Persons interested in obtaining a copy and 4 p.m., Monday through Friday, and mail.nih.gov. Formal requests for of the guidance may do so by using the will be posted to the docket at http:// additional plans and instruments must Internet. A search capability for all www.regulations.gov. be requested in writing. CDRH guidance documents is available Comment Due Date: Comments Dated: March 11, 2015. at http://www.fda.gov/MedicalDevices/ regarding this information collection are DeviceRegulationandGuidance/ Leslie Kux, best assured of having their full effect if GuidanceDocuments/default.htm. Associate Commissioner for Policy. received within 60 days of the date of Guidance documents are also available [FR Doc. 2015–06029 Filed 3–16–15; 8:45 am] this publication. at http://www.fda.gov/BiologicsBlood BILLING CODE 4164–01–P Proposed Collection: Surveys to Vaccines/GuidanceCompliance Support an Evaluation of the NHGRI RegulatoryInformation/Guidances/ Summer Workshop in Genomics (Short default.htm or http:// DEPARTMENT OF HEALTH AND Course), 0925–NEW, National Human www.regulations.gov. Persons unable to HUMAN SERVICES Genome Research Institute (NHGRI), download an electronic copy of National Institutes of Health (NIH). National Institutes of Health Need and Use of Information ‘‘Reprocessing Medical Devices in Health Care Settings: Validation Collection: The purpose of the proposed Proposed Collection; 60-Day Comment Methods and Labeling’’ may send an data collection activity is to complete a Request Surveys To Support an email request to CDRH- full-scale outcome evaluation of Evaluation of the National Human Guidance@fda.hhs.gov to receive an NHGRI’s Summer Workshop in Genome Research Institute (NHGRI) electronic copy of the document. Please Genomics (a.k.a., the ‘‘Short Course’’) Summer Workshop in Genomics (Short use the document number 1748 to focusing on program participants Course) identify the guidance you are between 2004 and 2012. This training requesting. SUMMARY: In compliance with the program is an intensive multi-day requirement of Section 3506(c)(2)(A) of course that updates instructors and IV. Paperwork Reduction Act of 1995 mstockstill on DSK4VPTVN1PROD with NOTICES the Paperwork Reduction Act of 1995, researchers of biology and nursing (and This guidance refers to previously for opportunity for public comment on other related disciplines) on the latest approved collections of information proposed data collection projects, the research trends and topics in genomic found in FDA regulations. These National Human Genome Research science. The course focuses on the collections of information are subject to Institute (NHGRI), National Institutes of continuing effort to find the genetic review by the Office of Management and Health (NIH), will publish periodic basis of various diseases and disorders, Budget (OMB) under the Paperwork summaries of proposed projects to be and current topics on the ethical, legal Reduction Act of 1995 (44 U.S.C. 3501– submitted to the Office of Management and social implications of genomics. VerDate Sep<11>2014 18:09 Mar 16, 2015 Jkt 235001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\17MRN1.SGM 17MRN1


Document Created: 2015-12-18 12:01:30
Document Modified: 2015-12-18 12:01:30
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesSubmit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time.
ContactAngela 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.
FR Citation80 FR 13864 
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