Document ID: FDA-2010-N-0198-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Premarket Notification
Posted Date: 2010-05-05T04:00Z

[Federal Register: May 5, 2010 (Volume 75, Number 86)]
[Notices]               
[Page 24708-24710]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05my10-99]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0198]

 
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 premarket notification.

DATES:  Submit written or electronic comments on the collection of 
information by July 6, 2010.

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 Piccad 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,

[[Page 24709]]

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 
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). 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:
     Introducing a device to the market for the first time;
     Introducing a device into commercial distribution for the 
first time by a person who is required to register; and
     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.
    Section 807.87 specifies information required in a premarket 
notification submission.
    Section 204 of the Food and Drug Administration Modernization Act 
(FDAMA) amended section 514 of the 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. (The 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) submitters.
    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.
    According to Sec.  807.90, submitters may request information on 
their 510(k) review status 90 days after the initial log-in 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:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                                                     Annual
              21 CFR  Section                 Form  Number         No. of        Frequency  per     Total Annual         Hours per         Total Hours
                                                                 Respondents        Response          Responses          Response
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807 subpart E                               ................             3,700                 1             3,700               79              292,300
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807.87                                         FDA Form 3514             1,956                 1             1,956                0.5                978
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807.90(a)(3)                                   FDA Form 3541               218                 1               218                0.25                55
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807.87(d) and (f)                              FDA Form 3654             1,500                 1             1,500               10               15,000
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[[Page 24710]]

807.93                                      ................             2,000                 1             2,000                0.5              1,000
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Totals                                                                                                                                           309,333
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA has based these estimates on conversations with industry and 
trade association representatives, and from internal review of the 
documents listed in table 1 of this document.

    Dated: April 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-10576 Filed 5-4-10; 8:45 am]
BILLING CODE 4160-01-S