[Federal Register Volume 79, Number 144 (Monday, July 28, 2014)]
[Notices]
[Pages 43753-43754]
[FR Doc No: 2014-17666]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0652]

The 510(k) Program: Evaluating Substantial Equivalence in
Premarket Notifications; Guidance for Industry and Food and Drug
Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of the guidance entitled ``The 510(k) Program: Evaluating
Substantial Equivalence in Premarket Notifications [510(k)].'' This
guidance document describes FDA's current review practices for
premarket notification (510(k)) submissions by describing in greater
detail the regulatory framework, policies, and practices underlying
FDA's review of traditional 510(k) submissions. This guidance document
does not address the special and abbreviated 510(k) programs. FDA
intends to finalize those sections separately.

DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.

ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``The 510(k) Program: Evaluating Substantial
Equivalence in Premarket Notifications [510(k)]'' 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 or the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your request. See the SUPPLEMENTARY INFORMATION section for information
on electronic access to the guidance.
    Submit electronic comments on the guidance to http://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. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Marjorie Shulman, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1536, Silver Spring, MD 20993-0002, 301-
796-6572; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    This guidance serves to identify, explain, and clarify each of the
critical decision points in the decision-making process FDA uses to
determine substantial equivalence under the 510(k) program. Since the
program's inception in 1976, FDA has periodically published documents,
including guidance

documents, which describe FDA's approach and any changes therein to the
510(k) program. On June 30, 1986, FDA published a Blue Book Memorandum
entitled ``Guidance on the CDRH Premarket Notification Review Program,
510(k) Memorandum K86-3'' (the ``K86-3 Memorandum'').
This document discussed general points regarding the process of
determining substantial equivalence between a new device and a
predicate device. On March 20, 1998, FDA published a guidance document
entitled ``The New 510(k) Paradigm--Alternate Approaches to
Demonstrating Substantial Equivalence in Premarket Notifications''
(``the New 510(k) Paradigm''). This guidance introduced two new 510(k)
programs--the Special 510(k) and the Abbreviated 510(k)--as optional
approaches available to device manufacturers and renames the original
510(k) program that had been in place since 1976 to the ``Traditional
510(k).'' Traditional, Special, and Abbreviated 510(k)s differ with
respect to the scope and content of information that are included
within the submission. It is noted that the K86-3 Memorandum
was issued as a final guidance prior to the February 27, 1997,
implementation of FDA's Good Guidance Practices, 21 CFR 10.115. Neither
the K86-3 Memorandum nor the New 510(k) Paradigm has been
updated since its initial publication. As further explained later in
this section, this new guidance document will replace only the
K86-3 Memorandum.
    On December 28, 2011, FDA announced the availability of ``Draft
Guidance for Industry and Food and Drug Administration Staff: The
510(k) Program: Evaluating Substantial Equivalence in Premarket
Notifications [510(k)]'' (76 FR 81510) (the ``Draft Guidance'').
Interested persons were invited to comment by April 26, 2012. FDA
received 26 sets of comments, totaling over 400 comments. While the
sections on Special 510(k), technological characteristics, and
predicate devices received the most comments, there were also requests
for inclusion of examples to assist in defining the gray areas of how
FDA interprets what would be considered substantially equivalent under
the 510(k) program.
    In response to these comments, the guidance was revised to provide
a broader overview of the use of predicate devices and to explain more
clearly the intent and value of defining a ``primary predicate'' device
in the submission. Examples were added to several sections to clarify
the boundaries and FDA's decision-making process for finding devices
equivalent to a predicate that may have different indications for use,
technological characteristics, or performance characteristics. There
were requests for the addition of a ``fillable form'' to ensure
consistency in the amount and type of detail expected in a 510(k)
summary. In response, an appendix was added with a sample 510(k)
summary, including clinical data, to demonstrate the level of detail
that is expected in each regulatory mandated section upon finalization
of the guidance to increase transparency.
    Lastly, industry expressed concern relating to the inclusion of the
Special 510(k) Program within this guidance, given the connection of
this topic and determining when it is necessary to submit a new 510(k)
for a device modification. In response, FDA elected to remove the
sections addressing the alternatives to Traditional 510(k)s,
specifically the Special and Abbreviated 510(k) programs that were
included in the draft guidance. FDA intends to finalize these sections
separately. Until FDA issues a new final guidance document on the
Special and Abbreviated 510(k) Programs, the recommendations for
Special and Abbreviated 510(k)s contained in the New 510(k) Paradigm
remain in effect for these alternate submission types.
    In response to other minor substantive and editorial comments, FDA
revised the guidance document to clarify the processes and policies as
appropriate.

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
Agency's current thinking on ``The 510(k) Program: Evaluating
Substantial Equivalence in Premarket Notifications [510(k)].'' It does
not create or confer any rights for or on any person and does not
operate to bind FDA or the public. An alternative approach may be used
if such approach satisfies the requirements of the applicable statute
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 http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov or http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Persons unable to
download an electronic copy of ``The 510(k) Program: Evaluating
Substantial Equivalence in Premarket Notifications [510(k)]'' may send
an email request to<EMAIL_ADDRESS>to receive an electronic
copy of the document. Please use the document number 1766 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 820 have been approved under
OMB control number 0910-0073; 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 807 subpart E have been approved
under OMB control number 0910-0120; the collections of information in
21 CFR 56.115 have been approved under OMB control number 0910-0130;
the collections of information found in 21 CFR part 814 have been
approved under OMB control number 0910-0231; the collections of
information in 21 CFR part 803 have been approved under OMB control
number 0910-0437; and the collections of information in 21 CFR part 801
have been approved under OMB control number 0910-0485.

V. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

    Dated: July 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-17666 Filed 7-25-14; 8:45 am]
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[Federal Register: March 19, 2009 (Volume 74, Number 52)]
[Notices]
[Page 11734-11735]
[DOCID:fr19mr09-56]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2008-M-0535, FDA-2008-M-0547, FDA-2008-M-0536, FDA-
2008-M-0563, FDA-2008-M-0593, FDA-2008-M-0601, FDA-2008-M-0562, FDA-
2008-M-0596, FDA-2008-M-0579, FDA-2008-M-0594, FDA-2008-M-0608, FDA-
2008-M-0645, FDA-2008-M-0646]

Medical Devices; Availability of Safety and Effectiveness
Summaries for Premarket Approval Applications

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY: The Food and Drug Administration (FDA) is publishing a list of
premarket approval applications (PMAs) that have been approved. This
list is intended to inform the public of the availability of safety and
effectiveness summaries of approved PMAs through the Internet and the
agency's Division of Dockets Management.

ADDRESSES: Submit written requests for copies of summaries of safety
and effectiveness data to the Division of Dockets Management (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852. Please cite the appropriate docket number as listed in Table
1 of this document when submitting a written request. See the
SUPPLEMENTARY INFORMATION section for electronic access to the
summaries of safety and effectiveness.

FOR FURTHER INFORMATION CONTACT: Nicole Wolanski, Center for Devices
and Radiological Health (HFZ-402), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of January 30, 1998 (63 FR 4571), FDA
published a final rule that revised 21 CFR 814.44(d) and 814.45(d) to
discontinue individual publication of PMA approvals and denials in the
Federal Register. Instead, the agency now posts this information on the
Internet on FDA's home page at http://www.fda.gov. FDA believes that
this procedure expedites public notification of these actions because
announcements can be placed on the Internet more quickly than they can
be published in the Federal Register, and FDA believes that the
Internet is accessible to more people than the Federal Register.
    In accordance with section 515(d)(4) and (e)(2) of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360e(d)(4) and
(e)(2)), notification of an order approving, denying, or withdrawing
approval of a PMA will continue to include a notice of opportunity to
request review of the order under section 515(g) of the act. The 30 day
period for requesting reconsideration of an FDA action under Sec.
10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a PMA
begins on the day the notice is placed on the Internet. Section
10.33(b) provides that FDA may, for good cause, extend this 30 day
period. Reconsideration of a denial or withdrawal of approval of a PMA
may be sought only by the applicant; in these cases, the 30 day period
will begin when the applicant is notified by FDA in writing of its
decision.
    The regulations provide that FDA publish a quarterly list of
available safety and effectiveness summaries of PMA approvals and
denials that were announced during that quarter. The following is a
list of approved PMAs for which summaries of safety and effectiveness
were placed on the Internet from October 1, 2008, through December 31,
2008. There were no denial actions during this period. The list
provides the manufacturer's name, the product's generic name or the
trade name, and the approval date.

  Table 1--List of Safety and Effectiveness Summaries for Approved PMAs
     Made Available From October 1, 2008, through December 31, 2008.
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PMA No./Docket                                                 Approval
      No.          Applicant             TRADE NAME              Date
------------------------------------------------------------------------
P070015         Abbott          XIENCE V EVEROLIMUS ELUTING  July 2,
FDA-2008-M-053   Vascular Inc.   CORONARY STENT SYSTEM &      2008
 5                               PROMUS ELUTING CORONARY
                                 STENT SYSTEM
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P030025 (S28)    Boston         TAXUS EXPRESS2 PACLITAXEL    September
FDA-2008-M-054   Scientific      ELUTING CORONARY STENT       24, 2008
 7               Corp.           SYSTEM
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P080004         Hoya Surgical   HOYA ISPHERIC MODEL YA-60BB  September
FDA-2008-M-053   Optics, Inc.    INTRAOCULAR LENS             26, 2008
 6
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H070004         Levitronix,     LEVITRONIX CENTRIMAG RIGHT   October 7,
FDA-2008-M-056   LLC             VENTRICULAR ASSIST SYSTEM    2008
 3                               (RVAS)
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P060008         Boston          TAXUS LIBERTE' PACLITAXEL    October 10,
FDA-2008-M-059   Scientific      ELUTING CORONARY STENT       2008
 3               Corp.           SYSTEM
------------------------------------------------------------------------
P050029         Stereotaxis,    HELIOS II ABLATION CATHETER  October 10,
FDA-2008-M-060   Inc.                                         2008
 1
------------------------------------------------------------------------
H040004         Medtronic        INFUSE/MASTERGRAFT          October 10,
FDA-2008-M-056   Sofamor Danek   POSTEROLATERAL REVISION      2008
 2               USA, Inc.       DEVICE
------------------------------------------------------------------------
P050019         Boston          CAROTID WALLSTENT MONORAIL   October 23,
FDA-2008-M-059   Scientific      ENDOPROSTHESIS               2008
 6               Corp.
------------------------------------------------------------------------
H060002         Spiration,      IBV VALVE SYSTEM             October 24,
FDA-2008-M-057   Inc.                                         2008
 9
------------------------------------------------------------------------
P060025         ATS Medical,    ATS 3F AORTIC BIOPROSTHESIS  October 30,
FDA-2008-M-059   Inc.                                         2008
 4
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P080011         Coopervision     BIOFINITY COMFILCON A       November
FDA-2008-M-060   Manufacturing   (EXTENDED WEAR SOFT          19, 2008
 8               , Ltd.          CONTACT LENSES)
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P080007         Bard             BARD E-LUMINEXX VASCULAR    December 4,
FDA-2008-M-064   Peripheral      STENT                        2008
 5               Vascular Inc.
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P060006          Boston         BOSTON SCIENTIFIC EXPRESS     December
FDA-2008-M-064   Scientific      SD RENAL MONORAIL            11, 2008
 6               Corp.           PREMOUNTED STENT SYSTEM
------------------------------------------------------------------------

II. Electronic Access

    Persons with access to the Internet may obtain the documents at
http://www.fda.gov/cdrh/pmapage.html.

    Dated: March 10, 2009.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E9-6026 Filed 3-18-09; 8:45 am]

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[Federal Register Volume 87, Number 217 (Thursday, November 10, 2022)]
[Notices]
[Pages 67923-67924]
[FR Doc No: 2022-24527]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2022-0029; OMB No. 1660-NW152]

Agency Information Collection Activities: Proposed Collection;
Comment Request; Logistics Supply Chain Management System Cloud (LSCMS-
C) Access Control Form

AGENCY: Federal Emergency Management Agency, Department of Homeland
Security.

ACTION: 60-Day notice of new collection and request for comments.

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SUMMARY: The Federal Emergency Management Agency, as part of its
continuing effort to reduce paperwork and respondent burden, invites
the public to take this opportunity to comment on an existing
information collection in use without an Office of Management and
Budget (OMB) control number. In accordance with the Paperwork Reduction
Act of 1995, this notice seeks comments concerning the Logistics Supply
Chain Management System Cloud (LSCMS-C) Access Control Form, which is
required for internal and external personnel who need access to the
LSCMS-C operational system to process supply chain management
transactions.

DATES: Comments must be submitted on or before January 9, 2023.

ADDRESSES: Submit comments at www.regulations.gov under Docket ID FEMA-
2022-0029. Follow the instructions for submitting comments.
    All submissions received must include the agency name and Docket
ID, and will be posted, without change, to the Federal eRulemaking
Portal at http://www.regulations.gov, and will include any personal
information you provide. Therefore, submitting this information makes
it public. You may wish to read the Privacy and Security Notice that is
available via a link on the homepage of www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Natasha Hinkson, Logistics Management
Directorate, Logistics System Division IT Support Branch Chief, 202-
658-9394, [email protected]. You may contact the Information
Management Division for copies of the proposed collection of
information at email address: FEM[email protected].

SUPPLEMENTARY INFORMATION: The LSCMS-C system requires role-based
access, which is based on an individual's position, to complete day to
day supply chain management transactions for the Office of Response and
Recovery's Logistics Management Directorate (LMD). Transactions include
the ordering, tracking, monitoring, reporting, and shipping of FEMA
assets and critical commodities both domestically and Outside the
Continental United States (OCONUS) in support of disaster operations.
    Authorized users of the LSCMS-C operational system will have access
to minimal personally identifiable information, primarily point of
contact information associated with the disaster commodities and assets
order entry request for other end users to complete the fulfillment of
FEMA orders for ordering, receiving, and delivery of the commodities
and assets for FEMA Disaster Response and Recovery activities, as well
as non-disaster activities for Mission Support.
    The Transportation Service Providers (TSP) Registration Form is
additionally required for Transportation Service Providers who would
like to apply to be a part of the FEMA Standard Tender of Service (FEMA
STOS) program for FEMA STOS specific information that will be included
in their LSCMS-C profiles.
    The authorities to collect and use this information are applicable
to all Federal agencies under the Interstate Commerce Act, Federal
Acquisition Regulation (FAR), and General Services Administration's
Federal Management Regulation. The authorities include:
     Interstate Commerce Act, 49 U.S.C. 10721, 13712;
     Federal Acquisition Regulation, Subpart A-General; part
47, ``Transportation'';
     Federal Management Regulation, 41 CFR parts 102-117, 102-
118;
     The Robert T. Stafford Disaster Relief and Emergency
Assistance Act, 42 U.S.C. 5121-5207;
     Homeland Security Act of 2002, 6 U.S.C. 311 et seq.

Collection of Information

    Title: Logistics Supply Chain Management System Cloud (LSCMS-C)
Access Control Form.
    Type of Information Collection: Existing collection in use without
an OMB control number.
    OMB Number: 1660-NW152.
    FEMA Forms: FEMA Form FF-145-FY-22-102 (formerly 119-0-0-20),
Logistics Supply Chain Management System Cloud (LSCMS-C) Access Control
Form; FEMA Form FF-145-FY-22-103, Transportation Service Providers
(TSP) Registration Form.
    Abstract: The Logistics Supply Chain Management System Cloud
(LSCMS-C) Access Control Form is required for FEMA or Non-FEMA
personnel who require access to the LSCMS-C operational system,
enabling end users to process supply chain management transactions. The
LSCMS-C Access Control Form is completed by internal and external users
who require access. The Transportation Service Providers (TSP)
Registration Form is additionally required for Transportation Service
Providers who would like to apply to be a part of the FEMA Standard
Tender of Service (FEMA STOS) program for FEMA STOS specific
information that will be included in their LSCMS-C profiles.
    Affected Public: Business or other for-profit.
    Estimated Number of Respondents: 984.
    Estimated Number of Responses: 2,952.
    Estimated Total Annual Burden Hours: 885.6.
    Estimated Total Annual Respondent Cost: $25,531.
    Estimated Respondents' Operation and Maintenance Costs: $0.
    Estimated Respondents' Capital and Start-Up Costs: $0.
    Estimated Total Annual Cost to the Federal Government: $3,775,509.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to (a) evaluate whether the proposed data
collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) enhance the quality, utility, and
clarity of the information to be collected; and (d) minimize the burden
of the collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses.

Millicent Brown Wilson,
Records Management Branch Chief, Office of the Chief Administrative
Officer, Mission Support, Federal Emergency Management Agency,
Department of Homeland Security.
[FR Doc. 2022-24527 Filed 11-9-22; 8:45 am]
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