[Federal Register Volume 72, Number 78 (Tuesday, April 24, 2007)]
[Notices]
[Pages 20345-20346]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-7700]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0122]


Guidance for Industry and Food and Drug Administration Staff; 
Class II Special Controls Guidance Document: Computerized Labor 
Monitoring Systems; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Guidance for Industry and FDA 
Staff; Class II Special Controls Guidance Document: Computerized Labor 
Monitoring Systems.'' This guidance document describes a means by which 
computerized labor monitoring systems may comply with the requirement 
of special controls for class II devices. Elsewhere in this issue of 
the Federal Register, FDA is publishing a final rule to classify 
computerized labor monitoring systems into class II (special controls). 
This guidance document is being immediately implemented as the special 
control for computerized labor monitoring systems, but it remains 
subject to comment in accordance with the agency's good guidance 
practices (GGPs).

DATES: Submit written or electronic comments on this guidance at any 
time. General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Submit written requests for single copies of the guidance 
document entitled ``Guidance for Industry and FDA Staff; Class II 
Special Controls Guidance Document: Computerized Labor Monitoring 
Systems'' to the Division of Small Manufacturers, International, and 
Consumer Assistance (HFZ-220), Center for Devices and Radiological 
Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 
20850. Send one self-addressed adhesive label to assist that office in 
processing your request, or fax your request to 240-276-3151. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the guidance.
    Submit written comments concerning this guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
tohttp://www.fda.gov/dockets/ecomments. Identify comments with the 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Glenn Bell, Center for Devices and 
Radiological Health (HFZ-470), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 240-276-4100.

SUPPLEMENTARY INFORMATION: 

I. Background

    Elsewhere in this issue of the Federal Register, FDA is publishing 
a final rule classifying computerized labor monitoring systems into 
class II (special controls) under section 513(f)(2) of the Federal 
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360c(f)(2)). This 
guidance document will serve as the special control for computerized 
labor monitoring systems. Section 513(f)(2) of the act provides that 
any person who submits a premarket notification under section 510(k) of 
the act (21 U.S.C. 360(k)) for a device that has not previously been 
classified may, within 30 days after receiving an order classifying the 
device in class III under section 513(f)(1) of the act, request FDA to 
classify the device under the criteria set forth in section 513(a)(1) 
of the act. FDA shall, within 60 days of receiving such a request, 
classify the device by written order. This classification shall be the 
initial classification of the device. Within 30 days after the issuance 
of an order classifying the device, FDA must publish a notice in the 
Federal Register announcing such classification. Because of the time 
frames established by section 513(f)(2) of the act, FDA has determined, 
under Sec.  10.115(g)(2) (21 CFR 10.115(g)(2)), that it is not feasible 
to allow for public participation before issuing this guidance as a 
final guidance document. Thus, FDA is issuing this guidance document as 
a level 1 guidance document that is immediately implemented. FDA will 
consider any comments that are received in response to this notice to 
determine whether to amend the guidance document.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's GGPs regulation 
(Sec.  10.115). The guidance represents the agency's current thinking 
on computerized labor monitoring systems. It does not create or confer 
any rights for or on any person and does not operate to bind FDA or the 
public. An alternative approach may be used if such approach satisfies 
the requirements of the applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
using the Internet. To receive ``Guidance for Industry and FDA Staff; 
Class II Special Controls Guidance Document: Computerized Labor 
Monitoring Systems,'' you may either send an e-mail request to 
<a href="/cdn-cgi/l/email-protection#a9cddac4c0cac8e9cfcdc887c1c1da87cec6df"><span class="__cf_email__" data-cfemail="284c5b45414b49684e4c490640405b064f475e">[email protected]</span></a> to receive an electronic copy of the document or 
send a fax request to 240-276-3151 to receive a hard copy. Please use 
the document number 1625 to identify the guidance you are requesting.
    CDRH maintains an entry on the Internet for easy access to 
information, including text, graphics, and files that may be downloaded 
to a personal computer with Internet access. Updated on a regular 
basis, the CDRH home page includes device safety alerts, Federal 
Register reprints, information on premarket submissions (including 
lists of approved applications and manufacturers' addresses), small 
manufacturer's assistance, information on video conferencing and 
electronic submissions, Mammography Matters, and other device-oriented 
information. The CDRH Web site may be accessed at http://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available 
at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also 
available on the Division of Dockets Management Internet site at http://www.fda.gov/ohrms/dockets.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 807, subpart E, have been 
approved under OMB control number 0910-0120; the collections of 
information in 21 CFR part 820 have been approved under OMB control 
number 0910-0073; and the collections of information in 21 CFR part 801 
have been approved under OMB control number 0910-0485.

[[Page 20346]]

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: April 13, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-7700 Filed 4-23-07; 8:45 am]
BILLING CODE 4160-01-S


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