Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 035, 27873-27874 [2014-11171]
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Federal Register / Vol. 79, No. 94 / Thursday, May 15, 2014 / Notices
ElectronicSubmissions/ucm253101.htm,
https://www.regulations.gov, or https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm.
Dated: May 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–11178 Filed 5–14–14; 8:45 am]
BILLING CODE 4160–01–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:
035
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) 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: 035’’
(‘‘Recognition List Number: 035’’), will
assist manufacturers who elect to
declare conformity with consensus
standards to meet certain requirements
for medical devices.
DATES: Submit either electronic or
written comments concerning this
document at any time. See section VI for
the effective date of the recognition of
standards announced in this document.
ADDRESSES: Submit written requests for
single copies of the document entitled
‘‘Modifications to the List of Recognized
SUMMARY:
Standards, Recognition List Number:
035’’ to the Division of Industry and
Consumer Education, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 4613, Silver Spring,
MD 20993–0002. Send two selfaddressed adhesive labels to assist that
office in processing your requests, or fax
your request to 301–847–8149.
Submit electronic or written
comments concerning this document or
concerning recommendations for
additional standards for recognition to
the contact person (see FOR FURTHER
INFORMATION CONTACT). This document
may also be accessed on FDA’s Internet
site at https://www.fda.gov/Medical
Devices/DeviceRegulationandGuidance/
Standards/ucm123792.htm. See section
V of this document for electronic access
to the searchable database for the
current list of FDA recognized
consensus standards, including
Recognition List Number: 035
modifications and other standards
related information.
FOR FURTHER INFORMATION CONTACT:
Scott A. Colburn, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 3632, Silver Spring,
MD 20993–0002, 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 notice 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
notice 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 notices describe the addition,
withdrawal, and revision of certain
standards recognized by FDA. The
Agency maintains hypertext markup
language and portable document format
versions of the list of FDA Recognized
Consensus Standards. Both versions are
publicly accessible at the Agency’s
Internet site. See section V 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: 035
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. We will incorporate these
modifications in the list of FDA
Recognized Consensus Standards in the
Agency’s searchable database, using the
term ‘‘Recognition List Number: 035’’ to
identify these current modifications.
In table 1 of this document, 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.
TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS
Old recognition No.
Replacement
recognition No.
Title of standard 1
Change
A. Radiology
TKELLEY on DSK3SPTVN1PROD with NOTICES
12–207 .....................................
........................
12–208 .....................................
........................
VerDate Mar<15>2010
18:18 May 14, 2014
Jkt 232001
IEC 60601–2–33 Edition 3.0 2010–03, Medical electrical
equipment—Part 2–33: Particular requirements for the
basic safety and essential performance of magnetic resonance equipment for medical diagnosis.
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.
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
E:\FR\FM\15MYN1.SGM
15MYN1
Recognition restored with
transition period.
Recognition restored with
transition period.
27874
Federal Register / Vol. 79, No. 94 / Thursday, May 15, 2014 / Notices
TABLE 1—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued
Old recognition No.
Replacement
recognition No.
Title of standard 1
12–210 .....................................
........................
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.
1 All
Recognition restored with
transition period.
standard titles in this table conform to the style requirements of the respective organizations.
III. 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 our Internet
site at https://www.accessdata.fda.gov/
scripts/cdrh/cfdocs/cfStandards/
search.cfm. We 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. We 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 Number: 033, we will
no longer announce minor revisions to
the list of recognized consensus
standards such as technical contact
person, relevant guidance, processes
affected, Code of Federal Regulations
citations, and product codes.
TKELLEY on DSK3SPTVN1PROD with NOTICES
Change
IV. 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 the contact person
(see FOR FURTHER INFORMATION CONTACT).
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.
V. 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
VerDate Mar<15>2010
18:18 May 14, 2014
Jkt 232001
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 includes the guidance
as well as the current list of recognized
standards and other standards-related
documents. After publication in the
Federal Register, this notice
announcing ‘‘Modification to the List of
Recognized Standards, Recognition List
Number: 035’’ will be available on the
CDRH home page. You may access the
CDRH home page at https://www.fda.gov/
MedicalDevices.
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/DeviceRegulationand
Guidance/Standards.
This Federal Register document on
modifications in FDA’s recognition of
consensus standards is available at
https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
Standards/ucm123792.htm.
VI. Submission of Comments and
Effective Date
Interested persons may submit either
electronic or written comments
concerning this document or concerning
recommendations for additional
standards for recognition to the contact
person (see FOR FURTHER INFORMATION
CONTACT). 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:
035. These modifications to the list of
recognized standards are effective upon
publication of this notice in the Federal
Register.
Dated: May 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–11171 Filed 5–14–14; 8:45 am]
BILLING CODE 4160–01–P
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Frm 00038
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–0547]
Guidance for Industry on Abbreviated
New Drug Applications: Stability
Testing of Drug Substances and
Products, Questions and Answers;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘ANDAs: Stability Testing of
Drug Substances and Products,
Questions and Answers.’’ It replaces the
draft guidance with the same name that
published on August 27, 2013 (78 FR
52931). This guidance clarifies stability
testing recommendations discussed in
International Conference on
Harmonisation (ICH) stability guidances
Q1A(R2) through Q1E for abbreviated
new drug applications (ANDAs) and
provides responses to public comments
in a questions-and-answers format.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Radhika Rajagopalan, Center for Drug
Evaluation and Research (HFD–640),
SUMMARY:
E:\FR\FM\15MYN1.SGM
15MYN1
]]>Agencies
[Federal Register Volume 79, Number 94 (Thursday, May 15, 2014)]
[Notices]
[Pages 27873-27874]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-11171]
-----------------------------------------------------------------------
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: 035
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) 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: 035'' (``Recognition List Number: 035''), will assist
manufacturers who elect to declare conformity with consensus standards
to meet certain requirements for medical devices.
DATES: Submit either electronic or written comments concerning this
document at any time. See section VI for the effective date of the
recognition of standards announced in this document.
ADDRESSES: Submit written requests for single copies of the document
entitled ``Modifications to the List of Recognized Standards,
Recognition List Number: 035'' to the Division of Industry and Consumer
Education, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver
Spring, MD 20993-0002. Send two self-addressed adhesive labels to
assist that office in processing your requests, or fax your request to
301-847-8149.
Submit electronic or written comments concerning this document or
concerning recommendations for additional standards for recognition to
the contact person (see FOR FURTHER INFORMATION CONTACT). This document
may also be accessed on FDA's Internet site at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See
section V of this document for electronic access to the searchable
database for the current list of FDA recognized consensus standards,
including Recognition List Number: 035 modifications and other
standards related information.
FOR FURTHER INFORMATION CONTACT: Scott A. Colburn, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 3632, Silver Spring, MD 20993-0002, 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 notice 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 notice 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 notices describe the addition, withdrawal, and revision of
certain standards recognized by FDA. The Agency maintains hypertext
markup language and portable document format versions of the list of
FDA Recognized Consensus Standards. Both versions are publicly
accessible at the Agency's Internet site. See section V 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: 035
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. We
will incorporate these modifications in the list of FDA Recognized
Consensus Standards in the Agency's searchable database, using the term
``Recognition List Number: 035'' to identify these current
modifications.
In table 1 of this document, 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.
Table 1--Modifications to the List of Recognized Standards
----------------------------------------------------------------------------------------------------------------
Replacement
Old recognition No. recognition No. Title of standard \1\ Change
----------------------------------------------------------------------------------------------------------------
A. Radiology
----------------------------------------------------------------------------------------------------------------
12-207............................. ...................... IEC 60601-2-33 Edition 3.0 Recognition restored
2010-03, Medical with transition
electrical equipment--Part period.
2-33: Particular
requirements for the basic
safety and essential
performance of magnetic
resonance equipment for
medical diagnosis.
12-208............................. ...................... IEC 60601-2-22 Third Recognition restored
edition 2007-05 Medical with transition
electrical equipment--Part period.
2-22: Particular
requirements for basic
safety and essential
performance of surgical,
cosmetic, therapeutic, and
diagnostic laser equipment.
[[Page 27874]]
12-210............................. ...................... IEC 60601-1-3 Edition 2.0 Recognition restored
2008-01 Medical electrical with transition
equipment--Part 1-3: period.
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.
III. 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 our
Internet site at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. We 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. We 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 Number: 033, we will no longer announce
minor revisions to the list of recognized consensus standards such as
technical contact person, relevant guidance, processes affected, Code
of Federal Regulations citations, and product codes.
IV. 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 the contact
person (see FOR FURTHER INFORMATION CONTACT). 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.
V. 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 includes the guidance as well as
the current list of recognized standards and other standards-related
documents. After publication in the Federal Register, this notice
announcing ``Modification to the List of Recognized Standards,
Recognition List Number: 035'' will be available on the CDRH home page.
You may access the CDRH home page at https://www.fda.gov/MedicalDevices.
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.
This Federal Register document on modifications in FDA's
recognition of consensus standards is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.
VI. Submission of Comments and Effective Date
Interested persons may submit either electronic or written comments
concerning this document or concerning recommendations for additional
standards for recognition to the contact person (see FOR FURTHER
INFORMATION CONTACT). 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: 035. These
modifications to the list of recognized standards are effective upon
publication of this notice in the Federal Register.
Dated: May 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-11171 Filed 5-14-14; 8:45 am]
BILLING CODE 4160-01-P
