82 FR 57281 - Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 048
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 231 (December 4, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 231 (December 4, 2017)
| Page Range | 57281-57282 | |
| FR Document | 2017-26043 |
[Federal Register Volume 82, Number 231 (Monday, December 4, 2017)] [Notices] [Pages 57281-57282] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-26043] [[Page 57281]] ----------------------------------------------------------------------- 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: 048 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: 048'' (Recognition List Number: 048), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. DATES: These modifications to the list of recognized standards are applicable December 4, 2017. ADDRESSES: You may submit electronic or written comments concerning this document at any time 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 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): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, 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: 048.'' 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 Dockets Management Staff 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: 048. 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 Dockets Management Staff. 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.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf. 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. An electronic copy of Recognition List Number: 048 is available on the internet at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. See section IV for electronic access to the searchable database for the current list of FDA recognized consensus standards, including Recognition List Number: 048 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: 048'' to Scott 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. Send one self- addressed adhesive label to assist that office in processing your request, or fax your request to 301-847-8144. FOR FURTHER INFORMATION CONTACT: Scott 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 (FDAMA) (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 the Federal Register notice 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. The guidance was updated in September 2007 and is available at [[Page 57282]] https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm077295.pdf. 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 (HTML) and portable document format (PDF) versions of the list of FDA Recognized Consensus Standards. Additional information on the Agency's standards program is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/default.htm. II. Listing of New Entries, Recognition List Number: 048 In table 1, FDA provides the listing of new entries and consensus standards added as modifications to the list of recognized standards under Recognition List Number: 048. FDA lists modifications the Agency is making that involve the initial addition of standards not previously recognized by FDA. Table 1--New Entries to the List of Recognized Standards ------------------------------------------------------------------------ Reference No. Recognition No. Title of standard \1\ and date ------------------------------------------------------------------------ A. Radiology ------------------------------------------------------------------------ 12-307........................ Radiation therapy AAMI RT2:2017. readiness check. ------------------------------------------------------------------------ B. Software/Informatics ------------------------------------------------------------------------ 13-98......................... Information ISO/IEC 646 technology--IS0 7-bit Third edition coded character set 1991-12-15. for information interchange. 13-99......................... Information ISO/IEC 15459-2 technology--Automatic Third edition identification and 2015-03-01. data capture techniques--Unique identification--Part 2: Registration procedures. 13-100........................ Information ISO/IEC 15459-4 technology--Automatic Third edition identification and 2014-11-15 data capture Corrected techniques--Unique version 2016-09- identification--Part 01. 4: Individual products and product packages. 13-101........................ Information ISO/IEC 15459-6 technology--Automatic Second edition identification and 2014-11-15 data capture Corrected techniques--Unique version 2016-09- identification--Part 01. 6: Groupings. 13-102........................ Application of risk IEC TR 80001-2-8 management for IT- Edition 1.0 networks 2016-05. incorporating medical devices--Part 2-8: Application guidance-- Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2. 13-103........................ Application of risk IEC TR 80001-2-9 management for IT- Edition 1.0 networks 2017-01. incorporating medical devices--Part 2-9: Application guidance-- Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities. ------------------------------------------------------------------------ \1\ All standard titles in this table conform to the style requirements of the respective organizations. III. List of Recognized Standards FDA maintains the current list of FDA Recognized Consensus Standards in a searchable database that may be accessed at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm. FDA will be incorporating the modifications described in this notice into the database and, upon publication in the Federal Register, this recognition of consensus standards will be effective. FDA will be announcing 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. 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 [email protected]. To be 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 electronic or mailing address of the requestor, (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. Dated: November 29, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-26043 Filed 12-1-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Notices 57281
DEPARTMENT OF HEALTH AND Written/Paper Submissions fdsys/pkg/FR-2015-09-18/pdf/2015-
HUMAN SERVICES Submit written/paper submissions as 23389.pdf.
follows: Docket: For access to the docket to
Food and Drug Administration • Mail/Hand delivery/Courier (for read background documents or the
[Docket No. FDA–2004–N–0451] written/paper submissions): Dockets electronic and written/paper comments
Management Staff (HFA–305), Food and received, go to https://
Food and Drug Administration Drug Administration, 5630 Fishers www.regulations.gov and insert the
Modernization Act of 1997: Lane, Rm. 1061, Rockville, MD 20852. docket number, found in brackets in the
Modifications to the List of Recognized • For written/paper comments heading of this document, into the
Standards, Recognition List Number: submitted to the Dockets Management ‘‘Search’’ box and follow the prompts
048 Staff, FDA will post your comment, as and/or go to the Dockets Management
well as any attachments, except for Staff, 5630 Fishers Lane, Rm. 1061,
AGENCY: Food and Drug Administration, Rockville, MD 20852.
HHS. information submitted, marked and
identified, as confidential, if submitted An electronic copy of Recognition List
ACTION: Notice. Number: 048 is available on the internet
as detailed in ‘‘Instructions.’’
SUMMARY: The Food and Drug Instructions: All submissions received at https://www.fda.gov/MedicalDevices/
Administration (FDA or Agency) is must include the Docket No. FDA– DeviceRegulationandGuidance/
announcing a publication containing 2004–N–0451 for ‘‘Food and Drug Standards/ucm123792.htm. See section
modifications the Agency is making to Administration Modernization Act of IV for electronic access to the searchable
the list of standards FDA recognizes for 1997: Modifications to the List of database for the current list of FDA
use in premarket reviews (FDA Recognized Standards, Recognition List recognized consensus standards,
Recognized Consensus Standards). This Number: 048.’’ Received comments will including Recognition List Number: 048
publication, entitled ‘‘Modifications to be placed in the docket and, except for modifications and other standards
the List of Recognized Standards, those submitted as ‘‘Confidential related information. Submit written
Recognition List Number: 048’’ Submissions,’’ publicly viewable at requests for a single hard copy of the
(Recognition List Number: 048), will https://www.regulations.gov or at the document entitled ‘‘Modifications to the
assist manufacturers who elect to Dockets Management Staff between 9 List of Recognized Standards,
declare conformity with consensus a.m. and 4 p.m., Monday through Recognition List Number: 048’’ to Scott
standards to meet certain requirements Friday. FDA will consider any Colburn, Center for Devices and
for medical devices. comments received in determining Radiological Health, Food and Drug
whether to amend the current listing of Administration, 10903 New Hampshire
DATES: These modifications to the list of
modifications to the list of recognized Ave., Bldg. 66, Rm. 5514, Silver Spring,
recognized standards are applicable
standards, Recognition List Number: MD 20993, 301–796–6287. Send one
December 4, 2017.
048. self-addressed adhesive label to assist
ADDRESSES: You may submit electronic
• Confidential Submissions—To that office in processing your request, or
or written comments concerning this fax your request to 301–847–8144.
document at any time as follows: submit a comment with confidential
information that you do not wish to be FOR FURTHER INFORMATION CONTACT:
Electronic Submissions made publicly available, submit your Scott Colburn, Center for Devices and
Submit electronic comments in the comments only as a written/paper Radiological Health, Food and Drug
following way: submission. You should submit two Administration, 10903 New Hampshire
• Federal eRulemaking Portal: copies total. One copy will include the Ave., Bldg. 66, Rm. 5514, Silver Spring,
https://www.regulations.gov. Follow the information you claim to be confidential MD 20993, 301–796–6287,
instructions for submitting comments. with a heading or cover note that states CDRHStandardsStaff@fda.hhs.gov.
Comments submitted electronically, ‘‘THIS DOCUMENT CONTAINS SUPPLEMENTARY INFORMATION:
including attachments, to https:// CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including I. Background
www.regulations.gov will be posted to
the docket unchanged. Because your the claimed confidential information, in Section 204 of the Food and Drug
comment will be made public, you are its consideration of comments. The Administration Modernization Act of
solely responsible for ensuring that your second copy, which will have the 1997 (FDAMA) (Pub. L. 105–115)
comment does not include any claimed confidential information amended section 514 of the Federal
confidential information that you or a redacted/blacked out, will be available Food, Drug, and Cosmetic Act (the
third party may not wish to be posted, for public viewing and posted on FD&C Act) (21 U.S.C. 360d). Amended
such as medical information, your or https://www.regulations.gov. Submit section 514 allows FDA to recognize
anyone else’s Social Security number, or both copies to the Dockets Management consensus standards developed by
confidential business information, such Staff. If you do not wish your name and international and national organizations
as a manufacturing process. Please note contact information to be made publicly for use in satisfying portions of device
that if you include your name, contact available, you can provide this premarket review submissions or other
information, or other information that information on the cover sheet and not requirements.
identifies you in the body of your in the body of your comments and you In the Federal Register notice of
comments, that information will be must identify this information as February 25, 1998 (63 FR 9561), FDA
‘‘confidential.’’ Any information marked announced the availability of a guidance
sradovich on DSK3GMQ082PROD with NOTICES
posted on https://www.regulations.gov.
• If you want to submit a comment as ‘‘confidential’’ will not be disclosed entitled ‘‘Recognition and Use of
with confidential information that you except in accordance with 21 CFR 10.20 Consensus Standards.’’ The notice
do not wish to be made available to the and other applicable disclosure law. For described how FDA would implement
public, submit the comment as a more information about FDA’s posting its standard recognition program and
written/paper submission and in the of comments to public dockets, see 80 provided the initial list of recognized
manner detailed (see ‘‘Written/Paper FR 56469, September 18, 2015, or access standards. The guidance was updated in
Submissions’’ and ‘‘Instructions’’). the information at: https://www.gpo.gov/ September 2007 and is available at
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![57282 Federal Register / Vol. 82, No. 231 / Monday, December 4, 2017 / Notices
https://www.fda.gov/downloads/ standards recognized by FDA. The II. Listing of New Entries, Recognition
MedicalDevices/DeviceRegulation Agency maintains hypertext markup List Number: 048
andGuidance/GuidanceDocuments/ language (HTML) and portable
ucm077295.pdf. document format (PDF) versions of the In table 1, FDA provides the listing of
Modifications to the initial list of list of FDA Recognized Consensus new entries and consensus standards
recognized standards, as published in Standards. Additional information on added as modifications to the list of
the Federal Register, can be accessed at the Agency’s standards program is recognized standards under Recognition
https://www.fda.gov/MedicalDevices/ available at https://www.fda.gov/ List Number: 048. FDA lists
DeviceRegulationandGuidance/ MedicalDevices/DeviceRegulation modifications the Agency is making that
Standards/ucm123792.htm. involve the initial addition of standards
andGuidance/Standards/default.htm.
These notices describe the addition, not previously recognized by FDA.
withdrawal, and revision of certain
TABLE 1—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS
Recognition No. Title of standard 1 Reference No. and date
A. Radiology
12–307 ................. Radiation therapy readiness check ................................................................. AAMI RT2:2017.
B. Software/Informatics
13–98 ................... Information technology—IS0 7-bit coded character set for information inter- ISO/IEC 646 Third edition 1991–12–15.
change.
13–99 ................... Information technology—Automatic identification and data capture tech- ISO/IEC 15459–2 Third edition 2015–03–01.
niques—Unique identification—Part 2: Registration procedures.
13–100 ................. Information technology—Automatic identification and data capture tech- ISO/IEC 15459–4 Third edition 2014–11–15
niques—Unique identification—Part 4: Individual products and product Corrected version 2016–09–01.
packages.
13–101 ................. Information technology—Automatic identification and data capture tech- ISO/IEC 15459–6 Second edition 2014–11–
niques—Unique identification—Part 6: Groupings. 15 Corrected version 2016–09–01.
13–102 ................. Application of risk management for IT-networks incorporating medical de- IEC TR 80001–2–8 Edition 1.0 2016–05.
vices—Part 2–8: Application guidance—Guidance on standards for estab-
lishing the security capabilities identified in IEC TR 80001–2–2.
13–103 ................. Application of risk management for IT-networks incorporating medical de- IEC TR 80001–2–9 Edition 1.0 2017–01.
vices—Part 2–9: Application guidance—Guidance for use of security as-
surance cases to demonstrate confidence in IEC TR 80001–2–2 security
capabilities.
1 All standard titles in this table conform to the style requirements of the respective organizations.
III. List of Recognized Standards following information: (1) Title of the DEPARTMENT OF HEALTH AND
FDA maintains the current list of FDA standard, (2) any reference number and HUMAN SERVICES
Recognized Consensus Standards in a date, (3) name and electronic or mailing
searchable database that may be address of the requestor, (4) a proposed Food and Drug Administration
accessed at https:// list of devices for which a declaration of
www.accessdata.fda.gov/scripts/cdrh/ conformity to this standard should [Docket No. FDA–2014–N–0192]
cfdocs/cfStandards/search.cfm. FDA routinely apply, and (5) a brief
will be incorporating the modifications identification of the testing or Agency Information Collection
described in this notice into the performance or other characteristics of Activities; Submission for Office of
database and, upon publication in the the device(s) that would be addressed Management and Budget Review;
Federal Register, this recognition of by a declaration of conformity. Comment Request; Establishing and
consensus standards will be effective. Maintaining Lists of United States
Dated: November 29, 2017.
FDA will be announcing additional Manufacturers/Processors With
modifications and revisions to the list of Leslie Kux, Interest in Exporting Center for Food
recognized consensus standards, as Associate Commissioner for Policy. Safety and Applied Nutrition-Regulated
needed, in the Federal Register once a [FR Doc. 2017–26043 Filed 12–1–17; 8:45 am] Products to China
year, or more often if necessary. BILLING CODE 4164–01–P
AGENCY: Food and Drug Administration,
IV. Recommendation of Standards for
Recognition by FDA HHS.
Any person may recommend ACTION: Notice.
consensus standards as candidates for
sradovich on DSK3GMQ082PROD with NOTICES
recognition under section 514 of the SUMMARY: The Food and Drug
FD&C Act by submitting such Administration (FDA) is announcing
recommendations, with reasons for the that a proposed collection of
recommendation, to information has been submitted to the
CDRHStandardsStaff@fda.hhs.gov. To Office of Management and Budget
be considered, such recommendations (OMB) for review and clearance under
should contain, at a minimum, the the Paperwork Reduction Act of 1995.
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Document Created: 2017-12-02 00:40:00
Document Modified: 2017-12-02 00:40:00
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | These modifications to the list of recognized standards are applicable December 4, 2017. | |
| Contact | Scott Colburn, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993, 301-796-6287, [email protected] | |
| FR Citation | 82 FR 57281 |
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