Document ID: FDA-2010-N-0198-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Premarket Notification
Posted Date: 2010-08-11T04:00Z

[Federal Register: August 11, 2010 (Volume 75, Number 154)]
[Notices]               
[Page 48696-48697]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11au10-70]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
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 
September 10, 2010.

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 e-mailed 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: 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: 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 
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

[[Page 48697]]

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. FDA 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).
    Form FDA 3514, a summary coversheet 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.
    In the Federal Register of May 5, 2010 (75 FR 24708), 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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                                                            No. of         Annual Frequency      Total Annual          Hours per
         21 CFR  Section             Form  Number         Respondents        per Response          Responses           Response           Total Hours
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807 subpart E                     ..................               3,800                   1               3,800               79                300,200
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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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807.92 and 807.93                 ..................               2,000                  10               2,000               10                 20,000
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Total                                                                                                                                            336,233
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: August 5, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-19746 Filed 8-10-10; 8:45 am]
BILLING CODE 4160-01-S