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)

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.

[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