[Federal Register Volume 81, Number 183 (Wednesday, September 21, 2016)]
[Notices]
[Pages 64917-64920]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22710]


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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.

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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
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                                          Replacement
          Old recognition No.             recognition        Title of standard \1\               Change
                                              No.
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                             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.
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                    B. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
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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).
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                              C. General Hospital/General Plastic Surgery (GH/GPS)
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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.
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                           D. Obstetrics-Gynecology (OB-GYN)/Gastroenterology/Urology
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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.
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                                                  E. Ophthalmic
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10-51.................................  ..............  ISO 15004-2 First edition 2007- Transition period.
                                                         02-15 Ophthalmic Instruments--
                                                         Fundamental requirements and
                                                         test methods--Part 2: Light
                                                         hazard protection.
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                                                  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)
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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.
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                      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