[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)
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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
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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.
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\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
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Reference No.
Recognition No. Title of standard \1\ and date
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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)
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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.
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C. Ophthalmic
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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.
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\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]
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