
[Federal Register Volume 78, Number 208 (Monday, October 28, 2013)]
[Notices]
[Pages 64220-64221]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-25298]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
November 27, 2013.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0120. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Premarket Notification--(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)

[[Page 64221]]

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.
    In the Federal Register of July 23, 2013 (78 FR 44130), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                   Number of
 Activity/21 CFR part/Section/     Number of     responses per   Total annual    Average burden     Total hours
           Form No.               respondents     respondent       responses      per response
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510(k) submission (807 subpart           3,900               1           3,900  79..............         308,100
 E).
Summary cover sheet (807.87)             1,956               1           1,956  0.5 (30 minutes)             978
 and FDA 3514.
Status request (807.90(a)(3))              218               1             218  0.25 (15                      55
 and FDA 3541.                                                                   minutes).
Standards (807.87(d) and (f));           2,700               1           2,700  10..............          27,000
 FDA 3654.
510(k) summary and statement               225              10           2,250  10..............          22,500
 (807.92 and 807.93).
                               ---------------------------------------------------------------------------------
    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: October 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-25298 Filed 10-25-13; 8:45 am]
BILLING CODE 4160-01-P


