
[Federal Register Volume 78, Number 141 (Tuesday, July 23, 2013)]
[Notices]
[Pages 44130-44132]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-17554]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0804]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Premarket Notification

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on medical device premarket 
notification.

DATES: Submit either electronic or written comments on the collection 
of information by September 23, 2013.

[[Page 44131]]


ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
daniel.gittleson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Premarket Notification--21 CFR Part 807, Subpart E (OMB Control Number 
0910-0120)--Extension

    Section 510(k) of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 360(k)) and the implementing regulation under part 
807 (21 CFR part 807, subpart E) requires a person who intends to 
market a medical device to submit a premarket notification submission 
to FDA at least 90 days before proposing to begin the introduction, or 
delivery for introduction into interstate commerce, for commercial 
distribution of a device intended for human use. Based on the 
information provided in the notification, FDA must determine whether 
the new device is substantially equivalent to a legally marketed 
device, as defined in Sec.  807.92(a)(3). If the device is determined 
to be not substantially equivalent to a legally marketed device, it 
must have an approved premarket approval application (PMA), Product 
Development Protocol, Humanitarian Device Exemption (HDE), Petition for 
Evaluation of Automatic Class III Designation (de novo), or be 
reclassified into class I or class II before being marketed. FDA makes 
the final decision of whether a device is substantially equivalent or 
not equivalent.
    Section 807.81 states when a premarket notification is required. A 
premarket notification is required to be submitted by a person who is: 
(1) Introducing a device to the market for the first time; (2) 
introducing a device into commercial distribution for the first time by 
a person who is required to register; and (3) introducing or 
reintroducing a device which is significantly changed or modified in 
design, components, method of manufacturer, or the intended use that 
could affect the safety and effectiveness of the device.
    Form FDA 3514, a summary cover sheet form, assists respondents in 
categorizing administrative 510(k) information for submission to FDA. 
This form also assists respondents in categorizing information for 
other FDA medical device programs such as PMAs, investigational device 
exemptions, and HDEs. Under Sec.  807.87(h), each 510(k) submitter must 
include in the 510(k) either a summary of the information in the 510(k) 
as required by Sec.  807.92 (510(k) summary) or a statement certifying 
that the submitter will make available upon request the information in 
the 510(k) with certain exceptions as per Sec.  807.93 (510(k) 
statement). If the 510(k) submitter includes a 510(k) statement in the 
510(k) submission, Sec.  807.93 requires that the official 
correspondent of the firm make available within 30 days of a request 
all information included in the submitted premarket notification on 
safety and effectiveness. This information will be provided to any 
person within 30 days of a request if the device described in the 
510(k) submission is determined to be substantially equivalent. The 
information provided will be a duplicate of the 510(k) submission 
including any safety and effectiveness information, but excluding all 
patient identifiers and trade secret and commercial confidential 
information.
    Section 204 of the Food and Drug Administration Modernization Act 
(FDAMA) (Pub. L. 105-115) amended section 514 of 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 including 
premarket notifications or other requirements. FDA has published and 
updated the list of recognized standards regularly since enactment of 
FDAMA and has allowed 510(k) submitters to certify conformance to 
recognized standards to meet the requirements of Sec.  807.87. Form FDA 
3654, the 510(k) Standards Data Form, standardizes the format for 
submitting information on consensus standards that a 510(k) submitter 
chooses to use as a portion of their premarket notification submission 
(Form FDA 3654 is not for declarations of conformance to a recognized 
standard). FDA believes that use of this form will simplify the 510(k) 
preparation and review process for 510(k).
    Under Sec.  807.90, submitters may request information on their 
510(k) review status 90 days after the initial login date of the 
510(k). Thereafter, the submitter may request status reports every 30 
days following the initial status request. To obtain a 510(k) status 
report, the submitter should complete the status request form, Form FDA 
3541, and fax it to the Center for Devices and Radiological Health 
office identified on the form.
    The most likely respondents to this information collection will be 
specification developers and medical device manufacturers.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 44132]]



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                                                                                      Number of
             Activity/21 CFR part/section/form No.                  Number of       responses per     Total annual     Average burden      Total hours
                                                                   respondents       respondent         responses       per response
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510(k) submission (807 subpart E).............................             3,900                 1             3,900                79           308,100
Summary cover sheet (807.87) and FDA 3514.....................             1,956                 1             1,956               0.5               978
                                                                                                                          (30 minutes)
Status request (807.90(a)(3)) and FDA 3541....................               218                 1               218              0.25                55
                                                                                                                          (15 minutes)
Standards (807.87(d) and (f)); FDA 3654.......................             2,700                 1             2,700                10            27,000
510(k) summary and statement (807.92 and 807.93)..............               225                10             2,250                10            22,500
                                                               -----------------------------------------------------------------------------------------
    Total.....................................................  ................  ................  ................  ................           358,633
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: July 16, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-17554 Filed 7-22-13; 8:45 am]
BILLING CODE 4160-01-P


