81_FR_65100 81 FR 64917 - Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 045

81 FR 64917 - Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 045

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 183 (September 21, 2016)

Page Range64917-64920
FR Document2016-22710

The Food and Drug Administration (FDA or Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 045'' (Recognition List Number: 045), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

Federal Register, Volume 81 Issue 183 (Wednesday, September 21, 2016) 
[Federal Register Volume 81, Number 183 (Wednesday, September 21, 2016)]
[Notices]
[Pages 64917-64920]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-22710]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-N-0451]


Food and Drug Administration Modernization Act of 1997: 
Modifications to the List of Recognized Standards, Recognition List 
Number: 045

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
a publication containing modifications the Agency is making to the list 
of standards FDA recognizes for use in premarket reviews (FDA 
Recognized Consensus Standards). This publication, entitled 
``Modifications to the List of Recognized Standards, Recognition List 
Number: 045'' (Recognition List Number: 045), will assist manufacturers 
who elect to declare conformity with consensus standards to meet 
certain requirements for medical devices.

DATES: Submit electronic or written comments concerning this document 
at any time. These modifications to the list of recognized standards 
are effective September 21, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact

[[Page 64918]]

information, or other information that identifies you in the body of 
your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2004-N-0451 for ``Food and Drug Administration Modernization Act of 
1997: Modifications to the List of Recognized Standards, Recognition 
List Number: 045.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at http://www.regulations.gov or at the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday. FDA will 
consider any comments received in determining whether to amend the 
current listing of modifications to the list of recognized standards, 
Recognition List Number: 045.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    An electronic copy of Recognition List Number: 045 is available on 
the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See section VI of 
this document for electronic access to the searchable database for the 
current list of FDA recognized consensus standards, including 
Recognition List Number: 045 modifications and other standards related 
information. Submit written requests for a single hard copy of the 
document entitled ``Modifications to the List of Recognized Standards, 
Recognition List Number: 045'' to Scott A. Colburn, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your request, or fax your request to 301-847-8149.

FOR FURTHER INFORMATION CONTACT: Scott A. Colburn, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993, 301-796-
6287, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Section 204 of the Food and Drug Administration Modernization Act 
of 1997 (Pub. L. 105-115) amended section 514 of the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360d). Amended section 
514 allows FDA to recognize consensus standards developed by 
international and national organizations for use in satisfying portions 
of device premarket review submissions or other requirements.
    In a document published in the Federal Register of February 25, 
1998 (63 FR 9561), FDA announced the availability of a guidance 
entitled ``Recognition and Use of Consensus Standards.'' The document 
described how FDA would implement its standard recognition program and 
provided the initial list of recognized standards.
    Modifications to the initial list of recognized standards, as 
published in the Federal Register, can be accessed at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.
    These documents describe the addition, withdrawal, and revision of 
certain standards recognized by FDA. The Agency maintains hypertext 
markup language (HTML) and portable document format (PDF) versions of 
the list of FDA Recognized Consensus Standards. Both versions are 
publicly accessible at the Agency's Internet site. See section VI of 
this document for electronic access information. Interested persons 
should review the supplementary information sheet for the standard to 
understand fully the extent to which FDA recognizes the standard.

II. Modifications to the List of Recognized Standards, Recognition List 
Number: 045

    FDA is announcing the addition, withdrawal, correction, and 
revision of certain consensus standards the Agency will recognize for 
use in premarket submissions and other requirements for devices. FDA 
will incorporate these modifications in the list of FDA Recognized 
Consensus Standards in the Agency's searchable database. FDA will use 
the term ``Recognition List Number: 045'' to identify these current 
modifications.
    In table 1, FDA describes the following modifications: (1) The 
withdrawal of standards and their replacement by others, if applicable; 
(2) the correction of errors made by FDA in listing previously 
recognized standards; and (3) the changes to the supplementary 
information sheets of recognized standards that describe revisions to 
the applicability of the standards.
    In section III, FDA lists modifications the Agency is making that 
involve the initial addition of standards not previously recognized by 
FDA.

[[Page 64919]]



                           Table 1--Modifications to the List of Recognized Standards
----------------------------------------------------------------------------------------------------------------
                                          Replacement
          Old recognition No.             recognition        Title of standard \1\               Change
                                              No.
----------------------------------------------------------------------------------------------------------------
                             A. General I (Quality Systems/Risk Management) (QS/RM)
----------------------------------------------------------------------------------------------------------------
5-85..................................  ..............  IEC 60601-1-6 Edition 3.0 2010- Withdrawn. See Rec# 5-
                                                         01 Medical electrical           89.
                                                         equipment--Part 1-6: General
                                                         requirements for basic safety
                                                         and essential performance--
                                                         Collateral standard:
                                                         Usability.
5-86..................................  ..............  IEC 60601-1-8 Edition 2.0 2006- Withdrawn. See Rec# 5-
                                                         10 Medical electrical           76.
                                                         equipment--Part 1-8: General
                                                         requirements for basic safety
                                                         and essential performance--
                                                         Collateral standard: General
                                                         requirements, tests and
                                                         guidance for alarm systems in
                                                         medical electrical equipment
                                                         and medical electrical
                                                         systems.
5-106.................................           5-109  ISO 80369-3 First edition 2016- Withdrawn and replaced
                                                         07-01 Small-bore connectors     with newer version.
                                                         for liquids and gases in
                                                         healthcare applications--Part
                                                         3: Connectors for enteral
                                                         applications.
----------------------------------------------------------------------------------------------------------------
                    B. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
----------------------------------------------------------------------------------------------------------------
19-3..................................  ..............  IEC 60601-1-10 Edition 1.0      Withdrawn. See Rec# 19-
                                                         2007-11 Medical electrical      9.
                                                         equipment--Part 1-10: General
                                                         requirements for basic safety
                                                         and essential performance--
                                                         Collateral standard:
                                                         Requirements for the
                                                         development of physiologic
                                                         closed-loop controllers.
19-5..................................  ..............  AAMI/ANSI ES60601-1:2005/(R)    Withdrawn. See Rec# 19-
                                                         2012 and C1:2009/(R) 2012 and   4.
                                                         A2:2010/(R) 2012
                                                         (Consolidated text) Medical
                                                         electrical equipment--Part 1:
                                                         General requirements for
                                                         basic safety and essential
                                                         performance (IEC 60601-
                                                         1:2005, MOD).
----------------------------------------------------------------------------------------------------------------
                              C. General Hospital/General Plastic Surgery (GH/GPS)
----------------------------------------------------------------------------------------------------------------
6-362.................................           6-379  ISO 7864 Fourth edition 2016-   Withdrawn and replaced
                                                         08-01 Sterile hypodermic        with newer version.
                                                         needles for single use--
                                                         Requirements and test methods.
6-366.................................           6-380  ISO 9626 Second edition 2016-   Withdrawn and replaced
                                                         08-01 Stainless steel needle    with newer version.
                                                         tubing for the manufacture of
                                                         medical devices--Requirements
                                                         and test methods.
6-376.................................           6-381  ISO 6009 Fourth edition 2016-   Withdrawn and replaced
                                                         08-01 Hypodermic needles for    with a newer version.
                                                         single use--Colour coding for
                                                         identification.
6-378.................................           6-382  ISO 11608-7 First edition 2016- Withdrawn and replaced
                                                         08-01 Needle-based injection    with a newer version.
                                                         systems for medical use--
                                                         Requirements and test
                                                         methods--Part 7:
                                                         Accessibility for persons
                                                         with visual impairment.
----------------------------------------------------------------------------------------------------------------
                           D. Obstetrics-Gynecology (OB-GYN)/Gastroenterology/Urology
----------------------------------------------------------------------------------------------------------------
9-61..................................  ..............  IEC 60601-2-18 Edition 3.0      Combined with 4-187.
                                                         2009-08 Medical electrical
                                                         equipment--Part 2-18:
                                                         Particular requirements for
                                                         the basic safety and
                                                         essential performance of
                                                         endoscopic equipment.
----------------------------------------------------------------------------------------------------------------
                                                  E. Ophthalmic
----------------------------------------------------------------------------------------------------------------
10-51.................................  ..............  ISO 15004-2 First edition 2007- Transition period.
                                                         02-15 Ophthalmic Instruments--
                                                         Fundamental requirements and
                                                         test methods--Part 2: Light
                                                         hazard protection.
----------------------------------------------------------------------------------------------------------------
                                                  F. Radiology
----------------------------------------------------------------------------------------------------------------
12-208................................  ..............  IEC 60601-2-22 Third Edition    Withdrawn. See Rec# 12-
                                                         2007-05 Medical electrical      268.
                                                         equipment--Part 2-22:
                                                         Particular requirements for
                                                         basic safety and essential
                                                         performance of surgical,
                                                         cosmetic, therapeutic and
                                                         diagnostic laser equipment.
12-210................................  ..............  IEC 60601-1-3 Edition 2.0 2008- Withdrawn. See Rec# 12-
                                                         01 Medical electrical           269.
                                                         equipment--Part 1-3: General
                                                         requirements for basic safety
                                                         and essential performance--
                                                         Collateral standard:
                                                         Radiation protection in
                                                         diagnostic x-ray equipment.
----------------------------------------------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements of the respective organizations


[[Page 64920]]

III. Listing of New Entries

    In table 2, FDA provides the listing of new entries and consensus 
standards added as modifications to the list of recognized standards 
under Recognition List Number: 045.

        Table 2--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
                                                          Reference No.
        Recognition No.          Title of standard \1\      and date
------------------------------------------------------------------------
         A. General I (Quality Systems/Risk Management) (QS/RM)
------------------------------------------------------------------------
5-110.........................  Packaged-Products for   ISTA 3A 2008.
                                 Parcel Delivery
                                 System Shipment 70 kg
                                 (150 lb) or Less.
5-111.........................  Packaged-Products for   ISTA 3B 2012.
                                 Less-Than-Truckload
                                 (LTL) Shipment.
5-112.........................  Unitized Loads of Same  ISTA 3E 2009.
                                 Product.
------------------------------------------------------------------------
                      B. In Vitro Diagnostics (IVD)
------------------------------------------------------------------------
7-265.........................  Liquid Chromatography-  C62-A: 2014.
                                 Mass Spectrometry
                                 Methods; Approved
                                 Guideline.
7-266.........................  A Framework for Using   EP19 Second
                                 CLSI Documents to       Edition: 2015.
                                 Evaluate Clinical
                                 Laboratory
                                 Measurement
                                 Procedures.
------------------------------------------------------------------------
                              C. Ophthalmic
------------------------------------------------------------------------
10-101........................  Ophthalmic optics--     ISO 18189 First
                                 Contact lenses and      edition 2016-06-
                                 contact lens care       01.
                                 products--Cytotoxicit
                                 y testing of contact
                                 lenses in combination
                                 with lens care
                                 solution to evaluate
                                 lens/solution
                                 interactions.
10-102........................  American National       ANSI Z80.36--
                                 Standard for            2016.
                                 Ophthalmics--Light
                                 Hazard Protection for
                                 Ophthalmic
                                 Instruments.
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
  of the respective organizations.

IV. List of Recognized Standards

    FDA maintains the Agency's current list of FDA Recognized Consensus 
Standards in a searchable database that may be accessed directly at 
FDA's Internet site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. FDA will incorporate the modifications 
and revisions described in this notice into the database and, upon 
publication in the Federal Register, this recognition of consensus 
standards will be effective. FDA will announce additional modifications 
and revisions to the list of recognized consensus standards, as needed, 
in the Federal Register once a year, or more often if necessary. 
Beginning with Recognition List 033, FDA no longer announces minor 
revisions to the list of recognized consensus standards such as 
technical contact person, devices affected, processes affected, Code of 
Federal Regulations citations, and product codes.

V. Recommendation of Standards for Recognition by FDA

    Any person may recommend consensus standards as candidates for 
recognition under section 514 of the FD&C Act by submitting such 
recommendations, with reasons for the recommendation, to 
[email protected]. To be properly considered, such recommendations 
should contain, at a minimum, the following information: (1) Title of 
the standard, (2) any reference number and date, (3) name and address 
of the national or international standards development organization, 
(4) a proposed list of devices for which a declaration of conformity to 
this standard should routinely apply, and (5) a brief identification of 
the testing or performance or other characteristics of the device(s) 
that would be addressed by a declaration of conformity.

VI. Electronic Access

    You may obtain a copy of ``Guidance on the Recognition and Use of 
Consensus Standards'' by using the Internet. The Center for Devices and 
Radiological Health (CDRH) maintains a site on the Internet for easy 
access to information including text, graphics, and files that you may 
download to a personal computer with access to the Internet. Updated on 
a regular basis, the CDRH home page, http://www.fda.gov/MedicalDevices, 
includes a link to standards-related documents including the guidance 
and the current list of recognized standards. After publication in the 
Federal Register, this notice announcing ``Modification to the List of 
Recognized Standards, Recognition List Number: 045'' will be available 
at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. You may access ``Guidance on the Recognition 
and Use of Consensus Standards,'' and the searchable database for ``FDA 
Recognized Consensus Standards'' at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards.

    Dated: September 15, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-22710 Filed 9-20-16; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 81, No. 183 / Wednesday, September 21, 2016 / Notices 64917 the claimed confidential information, in Submissions.’’ This guidance is H have been approved under OMB its consideration of comments. The intended to provide recommendations control number 0910–0332. second copy, which will have the to industry on the formatting, Dated: September 15, 2016. claimed confidential information organization, and content of reports for Leslie Kux, redacted/blacked out, will be available CM&S studies that are used as valid Associate Commissioner for Policy. for public viewing and posted on http:// scientific evidence to support medical device submissions. [FR Doc. 2016–22708 Filed 9–20–16; 8:45 am] www.regulations.gov. Submit both copies to the Division of Dockets In the Federal Register on January 17, BILLING CODE 4164–01–P Management. If you do not wish your 2014 (79 FR 3211), FDA announced the name and contact information to be availability of the draft guidance document. Interested persons were DEPARTMENT OF HEALTH AND made publicly available, you can invited to comment by April 17, 2014. HUMAN SERVICES provide this information on the cover sheet and not in the body of your II. Significance of Guidance Food and Drug Administration comments and you must identify this information as ‘‘confidential.’’ Any This guidance is being issued [Docket No. FDA–2004–N–0451] information marked as ‘‘confidential’’ consistent with FDA’s good guidance will not be disclosed except in practices regulation (21 CFR 10.115). Food and Drug Administration accordance with 21 CFR 10.20 and other The guidance represents the current Modernization Act of 1997: applicable disclosure law. For more thinking of FDA on ‘‘Reporting of Modifications to the List of Recognized information about FDA’s posting of Computational Modeling Studies in Standards, Recognition List Number: comments to public dockets, see 80 FR Medical Device Submissions’’. It does 045 56469, September 18, 2015, or access not establish any rights for any person AGENCY: Food and Drug Administration, the information at: http://www.fda.gov/ and is not binding on FDA or the public. HHS. regulatoryinformation/dockets/ You can use an alternative approach if it satisfies the requirements of the ACTION: Notice. default.htm. Docket: For access to the docket to applicable statutes and regulations. SUMMARY: The Food and Drug read background documents or the III. Electronic Access Administration (FDA or Agency) is electronic and written/paper comments announcing a publication containing Persons interested in obtaining a copy received, go to http:// modifications the Agency is making to of the guidance may do so by www.regulations.gov and insert the the list of standards FDA recognizes for downloading an electronic copy from docket number, found in brackets in the use in premarket reviews (FDA the Internet. A search capability for all heading of this document, into the Recognized Consensus Standards). This Center for Devices and Radiological ‘‘Search’’ box and follow the prompts publication, entitled ‘‘Modifications to Health guidance documents is available and/or go to the Division of Dockets the List of Recognized Standards, at http://www.fda.gov/MedicalDevices/ Management, 5630 Fishers Lane, Rm. Recognition List Number: 045’’ DeviceRegulationandGuidance/ 1061, Rockville, MD 20852. (Recognition List Number: 045), will GuidanceDocuments/default.htm. An electronic copy of the guidance assist manufacturers who elect to Guidance documents are also available document is available for download declare conformity with consensus at http://www.regulations.gov. Persons from the Internet. See the standards to meet certain requirements unable to download an electronic copy SUPPLEMENTARY INFORMATION section for for medical devices. of ‘‘Reporting of Computational information on electronic access to the DATES: Submit electronic or written Modeling Studies in Medical Device guidance. Submit written requests for a comments concerning this document at Submissions’’ may send an email single hard copy of the guidance any time. These modifications to the list request to CDRH-Guidance@fda.hhs.gov document entitled ‘‘Reporting of of recognized standards are effective to receive an electronic copy of the Computational Modeling Studies in September 21, 2016. document. Please use the document Medical Device Submissions’’ to the number 1807 to identify the guidance ADDRESSES: You may submit comments Office of the Center Director, Guidance you are requesting. as follows: and Policy Development, Center for Devices and Radiological Health, Food IV. Paperwork Reduction Act of 1995 Electronic Submissions and Drug Administration, 10903 New This guidance refers to previously Submit electronic comments in the Hampshire Ave., Bldg. 66, Rm. 5431, approved collections of information following way: Silver Spring, MD 20993–0002. Send found in FDA regulations. These • Federal eRulemaking Portal: http:// one self-addressed adhesive label to collections of information are subject to www.regulations.gov. Follow the assist that office in processing your review by the Office of Management and instructions for submitting comments. request. Budget (OMB) under the Paperwork Comments submitted electronically, FOR FURTHER INFORMATION CONTACT: Tina Reduction Act of 1995 (44 U.S.C. 3501– including attachments, to http:// Morrison, Center for Devices and 3520). The collections of information in www.regulations.gov will be posted to Radiological Health, Food and Drug 21 CFR part 807, subpart E have been the docket unchanged. Because your Administration, 10903 New Hampshire approved under OMB control number comment will be made public, you are Ave., Bldg. 62, Rm. 2204, Silver Spring, 0910–0120; the collections of solely responsible for ensuring that your MD 20993–0002, 301–796–6310. information in 21 CFR part 812 have comment does not include any mstockstill on DSK3G9T082PROD with NOTICES SUPPLEMENTARY INFORMATION: been approved under OMB control confidential information that you or a number 0910–0078; the collections of third party may not wish to be posted, I. Background information in 21 CFR part 814, such as medical information, your or FDA is announcing the availability of subparts A through E have been anyone else’s Social Security number, or a guidance for industry and FDA staff approved under OMB control number confidential business information, such entitled ‘‘Reporting of Computational 0910–0231; and the collections of as a manufacturing process. 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64918 Federal Register / Vol. 81, No. 183 / Wednesday, September 21, 2016 / Notices information, or other information that name and contact information to be FDA to recognize consensus standards identifies you in the body of your made publicly available, you can developed by international and national comments, that information will be provide this information on the cover organizations for use in satisfying posted on http://www.regulations.gov. sheet and not in the body of your portions of device premarket review • If you want to submit a comment comments and you must identify this submissions or other requirements. with confidential information that you information as ‘‘confidential.’’ Any In a document published in the do not wish to be made available to the information marked as ‘‘confidential’’ Federal Register of February 25, 1998 public, submit the comment as a will not be disclosed except in (63 FR 9561), FDA announced the written/paper submission and in the accordance with 21 CFR 10.20 and other availability of a guidance entitled manner detailed (see ‘‘Written/Paper applicable disclosure law. For more ‘‘Recognition and Use of Consensus Submissions’’ and ‘‘Instructions’’). information about FDA’s posting of Standards.’’ The document described Written/Paper Submissions comments to public dockets, see 80 FR how FDA would implement its standard 56469, September 18, 2015, or access recognition program and provided the Submit written/paper submissions as the information at: http://www.fda.gov/ follows: initial list of recognized standards. regulatoryinformation/dockets/ • Mail/Hand delivery/Courier (for Modifications to the initial list of default.htm. recognized standards, as published in written/paper submissions): Division of Docket: For access to the docket to Dockets Management (HFA–305), Food the Federal Register, can be accessed at read background documents or the and Drug Administration, 5630 Fishers http://www.fda.gov/MedicalDevices/ electronic and written/paper comments Lane, Rm. 1061, Rockville, MD 20852. DeviceRegulationandGuidance/ received, go to http:// • For written/paper comments Standards/ucm123792.htm. www.regulations.gov and insert the submitted to the Division of Dockets These documents describe the docket number, found in brackets in the Management, FDA will post your addition, withdrawal, and revision of heading of this document, into the comment, as well as any attachments, certain standards recognized by FDA. ‘‘Search’’ box and follow the prompts except for information submitted, The Agency maintains hypertext and/or go to the Division of Dockets marked and identified, as confidential, markup language (HTML) and portable if submitted as detailed in Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. document format (PDF) versions of the ‘‘Instructions.’’ list of FDA Recognized Consensus Instructions: All submissions received An electronic copy of Recognition List Number: 045 is available on the Internet Standards. Both versions are publicly must include the Docket No. FDA– accessible at the Agency’s Internet site. 2004–N–0451 for ‘‘Food and Drug at http://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ See section VI of this document for Administration Modernization Act of electronic access information. Interested 1997: Modifications to the List of Standards/ucm123792.htm. See section VI of this document for electronic access persons should review the Recognized Standards, Recognition List supplementary information sheet for the Number: 045.’’ Received comments will to the searchable database for the current list of FDA recognized standard to understand fully the extent be placed in the docket and, except for to which FDA recognizes the standard. those submitted as ‘‘Confidential consensus standards, including Submissions,’’ publicly viewable at Recognition List Number: 045 II. Modifications to the List of http://www.regulations.gov or at the modifications and other standards Recognized Standards, Recognition List Division of Dockets Management related information. Submit written Number: 045 between 9 a.m. and 4 p.m., Monday requests for a single hard copy of the document entitled ‘‘Modifications to the FDA is announcing the addition, through Friday. FDA will consider any List of Recognized Standards, withdrawal, correction, and revision of comments received in determining Recognition List Number: 045’’ to Scott certain consensus standards the Agency whether to amend the current listing of A. Colburn, Center for Devices and will recognize for use in premarket modifications to the list of recognized Radiological Health, Food and Drug submissions and other requirements for standards, Recognition List Number: Administration, 10903 New Hampshire devices. FDA will incorporate these 045. • Confidential Submissions—To Ave., Bldg. 66, Rm. 5514, Silver Spring, modifications in the list of FDA submit a comment with confidential MD 20993–0002. Send one self- Recognized Consensus Standards in the information that you do not wish to be addressed adhesive label to assist that Agency’s searchable database. FDA will made publicly available, submit your office in processing your request, or fax use the term ‘‘Recognition List Number: comments only as a written/paper your request to 301–847–8149. 045’’ to identify these current submission. You should submit two FOR FURTHER INFORMATION CONTACT: modifications. copies total. One copy will include the Scott A. Colburn, Center for Devices and In table 1, FDA describes the information you claim to be confidential Radiological Health, Food and Drug following modifications: (1) The with a heading or cover note that states Administration, 10903 New Hampshire withdrawal of standards and their ‘‘THIS DOCUMENT CONTAINS Ave., Bldg. 66, Rm. 5514, Silver Spring, replacement by others, if applicable; (2) CONFIDENTIAL INFORMATION.’’ The MD 20993, 301–796–6287, standards@ the correction of errors made by FDA in Agency will review this copy, including cdrh.fda.gov. listing previously recognized standards; the claimed confidential information, in SUPPLEMENTARY INFORMATION: and (3) the changes to the its consideration of comments. The supplementary information sheets of second copy, which will have the I. Background recognized standards that describe mstockstill on DSK3G9T082PROD with NOTICES claimed confidential information Section 204 of the Food and Drug revisions to the applicability of the redacted/blacked out, will be available Administration Modernization Act of standards. for public viewing and posted on http:// 1997 (Pub. L. 105–115) amended section In section III, FDA lists modifications www.regulations.gov. Submit both 514 of the Federal Food, Drug, and the Agency is making that involve the copies to the Division of Dockets Cosmetic Act (the FD&C Act) (21 U.S.C. initial addition of standards not Management. If you do not wish your 360d). Amended section 514 allows previously recognized by FDA. VerDate Sep<11>2014 18:19 Sep 20, 2016 Jkt 238001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\21SEN1.SGM 21SEN1

Federal Register / Vol. 81, No. 183 / Wednesday, September 21, 2016 / Notices 64919 TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS Replacement Old recognition No. recognition Title of standard 1 Change No. A. General I (Quality Systems/Risk Management) (QS/RM) 5–85 ......................................... ........................ IEC 60601–1–6 Edition 3.0 2010–01 Medical electrical equip- Withdrawn. See Rec# 5–89. ment—Part 1–6: General requirements for basic safety and essential performance—Collateral standard: Usability. 5–86 ......................................... ........................ IEC 60601–1–8 Edition 2.0 2006–10 Medical electrical equip- Withdrawn. See Rec# 5–76. ment—Part 1–8: General requirements for basic safety and essential performance—Collateral standard: General re- quirements, tests and guidance for alarm systems in med- ical electrical equipment and medical electrical systems. 5–106 ....................................... 5–109 ISO 80369–3 First edition 2016–07–01 Small-bore connec- Withdrawn and replaced with tors for liquids and gases in healthcare applications—Part newer version. 3: Connectors for enteral applications. B. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC) 19–3 ......................................... ........................ IEC 60601–1–10 Edition 1.0 2007–11 Medical electrical Withdrawn. See Rec# 19–9. equipment—Part 1–10: General requirements for basic safety and essential performance—Collateral standard: Re- quirements for the development of physiologic closed-loop controllers. 19–5 ......................................... ........................ AAMI/ANSI ES60601–1:2005/(R) 2012 and C1:2009/(R) Withdrawn. See Rec# 19–4. 2012 and A2:2010/(R) 2012 (Consolidated text) Medical electrical equipment—Part 1: General requirements for basic safety and essential performance (IEC 60601– 1:2005, MOD). C. General Hospital/General Plastic Surgery (GH/GPS) 6–362 ....................................... 6–379 ISO 7864 Fourth edition 2016–08–01 Sterile hypodermic Withdrawn and replaced with needles for single use—Requirements and test methods. newer version. 6–366 ....................................... 6–380 ISO 9626 Second edition 2016–08–01 Stainless steel needle Withdrawn and replaced with tubing for the manufacture of medical devices—Require- newer version. ments and test methods. 6–376 ....................................... 6–381 ISO 6009 Fourth edition 2016–08–01 Hypodermic needles Withdrawn and replaced with for single use—Colour coding for identification. a newer version. 6–378 ....................................... 6–382 ISO 11608–7 First edition 2016–08–01 Needle-based injec- Withdrawn and replaced with tion systems for medical use—Requirements and test a newer version. methods—Part 7: Accessibility for persons with visual im- pairment. D. Obstetrics-Gynecology (OB–GYN)/Gastroenterology/Urology 9–61 ......................................... ........................ IEC 60601–2–18 Edition 3.0 2009–08 Medical electrical Combined with 4–187. equipment—Part 2–18: Particular requirements for the basic safety and essential performance of endoscopic equipment. E. Ophthalmic 10–51 ....................................... ........................ ISO 15004–2 First edition 2007–02–15 Ophthalmic Instru- Transition period. ments—Fundamental requirements and test methods— Part 2: Light hazard protection. F. Radiology 12–208 ..................................... ........................ IEC 60601–2–22 Third Edition 2007–05 Medical electrical Withdrawn. See Rec# 12–268. equipment—Part 2–22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment. 12–210 ..................................... ........................ IEC 60601–1–3 Edition 2.0 2008–01 Medical electrical equip- Withdrawn. See Rec# 12–269. ment—Part 1–3: General requirements for basic safety and mstockstill on DSK3G9T082PROD with NOTICES essential performance—Collateral standard: Radiation pro- tection in diagnostic x-ray equipment. 1 All standard titles in this table conform to the style requirements of the respective organizations VerDate Sep<11>2014 18:19 Sep 20, 2016 Jkt 238001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\21SEN1.SGM 21SEN1

64920 Federal Register / Vol. 81, No. 183 / Wednesday, September 21, 2016 / Notices III. Listing of New Entries added as modifications to the list of In table 2, FDA provides the listing of recognized standards under Recognition new entries and consensus standards List Number: 045. TABLE 2—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS Recognition No. Title of standard 1 Reference No. and date A. General I (Quality Systems/Risk Management) (QS/RM) 5–110 .............................................. Packaged-Products for Parcel Delivery System Shipment 70 kg (150 ISTA 3A 2008. lb) or Less. 5–111 .............................................. Packaged-Products for Less-Than-Truckload (LTL) Shipment ............. ISTA 3B 2012. 5–112 .............................................. Unitized Loads of Same Product ........................................................... ISTA 3E 2009. B. In Vitro Diagnostics (IVD) 7–265 .............................................. Liquid Chromatography-Mass Spectrometry Methods; Approved C62–A: 2014. Guideline. 7–266 .............................................. A Framework for Using CLSI Documents to Evaluate Clinical Labora- EP19 Second Edition: 2015. tory Measurement Procedures. C. Ophthalmic 10–101 ............................................ Ophthalmic optics—Contact lenses and contact lens care products— ISO 18189 First edition 2016–06– Cytotoxicity testing of contact lenses in combination with lens care 01. solution to evaluate lens/solution interactions. 10–102 ............................................ American National Standard for Ophthalmics—Light Hazard Protec- ANSI Z80.36—2016. tion for Ophthalmic Instruments. 1 All standard titles in this table conform to the style requirements of the respective organizations. IV. List of Recognized Standards information: (1) Title of the standard, (2) the searchable database for ‘‘FDA any reference number and date, (3) Recognized Consensus Standards’’ at FDA maintains the Agency’s current name and address of the national or http://www.fda.gov/MedicalDevices/ list of FDA Recognized Consensus Standards in a searchable database that international standards development DeviceRegulationandGuidance/ may be accessed directly at FDA’s organization, (4) a proposed list of Standards. Internet site at http:// devices for which a declaration of Dated: September 15, 2016. www.accessdata.fda.gov/scripts/cdrh/ conformity to this standard should routinely apply, and (5) a brief Leslie Kux, cfdocs/cfStandards/search.cfm. FDA Associate Commissioner for Policy. will incorporate the modifications and identification of the testing or revisions described in this notice into performance or other characteristics of [FR Doc. 2016–22710 Filed 9–20–16; 8:45 am] the database and, upon publication in the device(s) that would be addressed BILLING CODE 4164–01–P the Federal Register, this recognition of by a declaration of conformity. consensus standards will be effective. VI. Electronic Access FDA will announce additional DEPARTMENT OF HEALTH AND modifications and revisions to the list of You may obtain a copy of ‘‘Guidance HUMAN SERVICES recognized consensus standards, as on the Recognition and Use of National Institutes of Health needed, in the Federal Register once a Consensus Standards’’ by using the year, or more often if necessary. Internet. The Center for Devices and Center For Scientific Review; Notice of Beginning with Recognition List 033, Radiological Health (CDRH) maintains a Closed Meetings FDA no longer announces minor site on the Internet for easy access to revisions to the list of recognized information including text, graphics, Pursuant to section 10(d) of the consensus standards such as technical and files that you may download to a Federal Advisory Committee Act, as contact person, devices affected, personal computer with access to the amended (5 U.S.C. App.), notice is processes affected, Code of Federal Internet. Updated on a regular basis, the hereby given of the following meetings. Regulations citations, and product CDRH home page, http://www.fda.gov/ codes. MedicalDevices, includes a link to The meetings will be closed to the standards-related documents including public in accordance with the V. Recommendation of Standards for provisions set forth in sections the guidance and the current list of Recognition by FDA 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., recognized standards. After publication Any person may recommend in the Federal Register, this notice as amended. The grant applications and consensus standards as candidates for announcing ‘‘Modification to the List of the discussions could disclose mstockstill on DSK3G9T082PROD with NOTICES recognition under section 514 of the Recognized Standards, Recognition List confidential trade secrets or commercial FD&C Act by submitting such Number: 045’’ will be available at http:// property such as patentable material, recommendations, with reasons for the www.fda.gov/MedicalDevices/ and personal information concerning recommendation, to standards@ DeviceRegulationandGuidance/ individuals associated with the grant cdrh.fda.gov. To be properly considered, Standards/ucm123792.htm. You may applications, the disclosure of which such recommendations should contain, access ‘‘Guidance on the Recognition would constitute a clearly unwarranted at a minimum, the following and Use of Consensus Standards,’’ and invasion of personal privacy. VerDate Sep<11>2014 18:19 Sep 20, 2016 Jkt 238001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\21SEN1.SGM 21SEN1


Document Created: 2016-09-21 01:31:03
Document Modified: 2016-09-21 01:31:03
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 electronic or written comments concerning this document at any time. These modifications to the list of recognized standards are effective September 21, 2016.
ContactScott A. Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993, 301-796- 6287, [email protected]
FR Citation81 FR 64917 
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