[Federal Register Volume 82, Number 51 (Friday, March 17, 2017)]
[Pages 14223-14224]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05300]



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 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


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 April 
17, 2017.

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 [email protected]. 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.

Food and Drug Administration, Three White Flint North 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, [email protected].

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--21 CFR Part 807, Subpart E

OMB Control Number 0910-0120--Reinstatement

    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) require 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) (21 CFR 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 
    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

[[Page 14224]]

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 
    In the Federal Register of November 18, 2016 (81 FR 81772), 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 

                                                     Table 1--Estimated Annual Reporting Burden \1\
                                                                            Number of
    Activity and 21 CFR part/section      Form FDA No.      Number of     responses per   Total annual     Average burden per  response     Total hours
                                                           respondents     respondent       responses
510(k) submission (807 subpart E)......  ..............           3,900               1           3,900  79.............................         308,100
Summary cover sheet (807.87)...........            3514           1,956               1           1,956  .5 (30 minutes)................             978
Status request (807.90(a)(3))..........            3541             218               1             218  .25 (15 minutes)...............              55
Standards (807.87(d) and (f))..........            3654           2,700               1           2,700  10.............................          27,000
510(k) statement (807.93)..............  ..............             225              10           2,250  10.............................          22,500
    Total..............................  ..............  ..............  ..............  ..............  ...............................         358,633
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: March 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05300 Filed 3-16-17; 8:45 am]