Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 045, 64917-64920 [2016-22710]

Download as PDF mstockstill on DSK3G9T082PROD with NOTICES Federal Register / Vol. 81, No. 183 / Wednesday, September 21, 2016 / Notices 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 https:// 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: https://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 https:// 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 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 ‘‘Reporting of Computational Modeling Studies in Medical Device Submissions’’ 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. Send one self-addressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: Tina Morrison, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 62, Rm. 2204, Silver Spring, MD 20993–0002, 301–796–6310. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a guidance for industry and FDA staff entitled ‘‘Reporting of Computational Modeling Studies in Medical Device VerDate Sep<11>2014 18:19 Sep 20, 2016 Jkt 238001 Submissions.’’ This guidance is intended to provide recommendations to industry on the formatting, organization, and content of reports for CM&S studies that are used as valid scientific evidence to support medical device submissions. In the Federal Register on January 17, 2014 (79 FR 3211), FDA announced the availability of the draft guidance document. Interested persons were invited to comment by April 17, 2014. 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 current thinking of FDA on ‘‘Reporting of Computational Modeling Studies in Medical Device Submissions’’. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. III. Electronic Access Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the Internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. Guidance documents are also available at https://www.regulations.gov. Persons unable to download an electronic copy of ‘‘Reporting of Computational Modeling Studies in Medical Device Submissions’’ may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1807 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 part 807, subpart E have been approved under OMB control number 0910–0120; the collections of information in 21 CFR part 812 have been approved under OMB control number 0910–0078; the collections of information in 21 CFR part 814, subparts A through E have been approved under OMB control number 0910–0231; and the collections of information in 21 CFR part 814, subpart PO 00000 Frm 00049 Fmt 4703 Sfmt 4703 64917 H have been approved under OMB control number 0910–0332. Dated: September 15, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–22708 Filed 9–20–16; 8:45 am] BILLING CODE 4164–01–P 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. 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: SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// 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 E:\FR\FM\21SEN1.SGM 21SEN1 64918 Federal Register / Vol. 81, No. 183 / Wednesday, September 21, 2016 / Notices mstockstill on DSK3G9T082PROD with NOTICES information, or other information that identifies you in the body of your comments, that information will be posted on https://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 https://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 https:// www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your VerDate Sep<11>2014 18:19 Sep 20, 2016 Jkt 238001 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: https://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 https:// 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 https://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 selfaddressed 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, standards@ cdrh.fda.gov. 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 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 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 https://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. E:\FR\FM\21SEN1.SGM 21SEN1 64919 Federal Register / Vol. 81, No. 183 / Wednesday, September 21, 2016 / Notices TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS Old recognition No. Replacement recognition No. Title of standard 1 Change A. General I (Quality Systems/Risk Management) (QS/RM) 5–85 ......................................... ........................ 5–86 ......................................... ........................ 5–106 ....................................... 5–109 IEC 60601–1–6 Edition 3.0 2010–01 Medical electrical equipment—Part 1–6: General requirements for basic safety and essential performance—Collateral standard: Usability. IEC 60601–1–8 Edition 2.0 2006–10 Medical electrical 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. ISO 80369–3 First edition 2016–07–01 Small-bore connectors for liquids and gases in healthcare applications—Part 3: Connectors for enteral applications. Withdrawn. See Rec# 5–89. Withdrawn. See Rec# 5–76. Withdrawn and replaced with newer version. B. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC) 19–3 ......................................... ........................ 19–5 ......................................... ........................ IEC 60601–1–10 Edition 1.0 2007–11 Medical electrical equipment—Part 1–10: General requirements for basic safety and essential performance—Collateral standard: Requirements for the development of physiologic closed-loop controllers. AAMI/ANSI ES60601–1:2005/(R) 2012 and C1:2009/(R) 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). Withdrawn. See Rec# 19–9. Withdrawn. See Rec# 19–4. C. General Hospital/General Plastic Surgery (GH/GPS) 6–362 ....................................... 6–379 6–366 ....................................... 6–380 6–376 ....................................... 6–381 6–378 ....................................... 6–382 ISO 7864 Fourth edition 2016–08–01 Sterile hypodermic needles for single use—Requirements and test methods. ISO 9626 Second edition 2016–08–01 Stainless steel needle tubing for the manufacture of medical devices—Requirements and test methods. ISO 6009 Fourth edition 2016–08–01 Hypodermic needles for single use—Colour coding for identification. ISO 11608–7 First edition 2016–08–01 Needle-based injection systems for medical use—Requirements and test methods—Part 7: Accessibility for persons with visual impairment. Withdrawn and replaced with newer version. Withdrawn and replaced with newer version. Withdrawn and replaced with a newer version. Withdrawn and replaced with a newer version. D. Obstetrics-Gynecology (OB–GYN)/Gastroenterology/Urology 9–61 ......................................... ........................ IEC 60601–2–18 Edition 3.0 2009–08 Medical electrical equipment—Part 2–18: Particular requirements for the basic safety and essential performance of endoscopic equipment. Combined with 4–187. E. Ophthalmic 10–51 ....................................... ........................ ISO 15004–2 First edition 2007–02–15 Ophthalmic Instruments—Fundamental requirements and test methods— Part 2: Light hazard protection. Transition period. F. Radiology ........................ 12–210 ..................................... mstockstill on DSK3G9T082PROD with NOTICES 12–208 ..................................... ........................ 1 All IEC 60601–2–22 Third Edition 2007–05 Medical electrical equipment—Part 2–22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment. IEC 60601–1–3 Edition 2.0 2008–01 Medical electrical equipment—Part 1–3: General requirements for basic safety and essential performance—Collateral standard: Radiation protection in diagnostic x-ray equipment. 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 Withdrawn. See Rec# 12–268. Withdrawn. See Rec# 12–269. 64920 Federal Register / Vol. 81, No. 183 / Wednesday, September 21, 2016 / Notices 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 Title of standard 1 Recognition No. Reference No. and date A. General I (Quality Systems/Risk Management) (QS/RM) 5–110 .............................................. 5–111 .............................................. 5–112 .............................................. Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less. Packaged-Products for Less-Than-Truckload (LTL) Shipment ............. Unitized Loads of Same Product ........................................................... ISTA 3A 2008. ISTA 3B 2012. ISTA 3E 2009. B. In Vitro Diagnostics (IVD) 7–265 .............................................. 7–266 .............................................. Liquid Chromatography-Mass Spectrometry Methods; Approved Guideline. A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures. C62–A: 2014. EP19 Second Edition: 2015. C. Ophthalmic 10–101 ............................................ 10–102 ............................................ 1 All Ophthalmic optics—Contact lenses and contact lens care products— Cytotoxicity testing of contact lenses in combination with lens care solution to evaluate lens/solution interactions. American National Standard for Ophthalmics—Light Hazard Protection for Ophthalmic Instruments. ANSI Z80.36—2016. 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 https:// 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. mstockstill on DSK3G9T082PROD with NOTICES ISO 18189 First edition 2016–06– 01. 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, https://www.fda.gov/ MedicalDevices, includes a link to standards-related documents including V. Recommendation of Standards for the guidance and the current list of Recognition by FDA recognized standards. After publication in the Federal Register, this notice Any person may recommend announcing ‘‘Modification to the List of consensus standards as candidates for Recognized Standards, Recognition List recognition under section 514 of the Number: 045’’ will be available at https:// FD&C Act by submitting such www.fda.gov/MedicalDevices/ recommendations, with reasons for the DeviceRegulationandGuidance/ recommendation, to standards@ cdrh.fda.gov. To be properly considered, Standards/ucm123792.htm. You may access ‘‘Guidance on the Recognition such recommendations should contain, and Use of Consensus Standards,’’ and at a minimum, the following VerDate Sep<11>2014 18:19 Sep 20, 2016 Jkt 238001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 the searchable database for ‘‘FDA Recognized Consensus Standards’’ at https://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 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center For Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. E:\FR\FM\21SEN1.SGM 21SEN1

Agencies

[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]

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

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: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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 https://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 https://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: https://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 https://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 https://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, standards@cdrh.fda.gov.

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 https://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 https://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
standards@cdrh.fda.gov. 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, https://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 https://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 https://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

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