Document ID: FDA-2011-D-0028-0001
Agency: fda
Document Type: Notice
Title: Guidance for Industry and Food and Drug Administration Staff; Availability: Class II Special Controls Guidance Document: Ovarian Adnexal Mass Assessment Score Test System
Posted Date: 2011-03-23T04:00Z

[Federal Register Volume 76, Number 56 (Wednesday, March 23, 2011)]
[Notices]
[Pages 16425-16426]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-6622]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0028]

Guidance for Industry and Food and Drug Administration Staff; 
Class II Special Controls Guidance Document: Ovarian Adnexal Mass 
Assessment Score Test System; 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 special controls guidance entitled ``Class II 
Special Controls Guidance Document: Ovarian Adnexal Mass Assessment 
Score Test System.'' This guidance document describes a means by which 
the ovarian adnexal mass assessment score test system 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 these device types into class II (special controls). This

[[Page 16426]]

guidance document is immediately in effect as the special control for 
the ovarian adnexal mass assessment score test system, 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 ``Class II Special Controls Guidance Document: 
Ovarian Adnexal Mass Assessment Score Test System'' to the Division of 
Small Manufacturers, International, and Consumer Assistance, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002. 
Send one self-addressed adhesive label to assist that office in 
processing your request, or fax your request to 301-847-8149. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the guidance.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:
Donna Roscoe, Center for Devices and Radiological Health, Food and Drug 
Administration, Bldg., 66, rm. 5540, 10903 New Hampshire Ave., Silver 
Spring, MD 20993, 301-796-6183; or
Marina Kondratovich, Center for Devices and Radiological Health, Food 
and Drug Administration, Bldg.66, rm. 5666, 10903 New Hampshire Ave., 
Silver Spring, MD 20993, 301-796-6036.

SUPPLEMENTARY INFORMATION: 

I. Background

    Elsewhere in this issue of the Federal Register, FDA is publishing 
a final rule codifying the classification of the ovarian adnexal mass 
assessment score test system into class II (special controls) under 
section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act) (21 U.S.C. 360c(f)(2)). This guidance document will serve as the 
special control for the ovarian adnexal mass assessment score test 
system. Section 513(f)(2) of the FD&C Act provides that any person who 
submits a premarket notification under section 510(k) of the FD&C 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 FD&C Act, request FDA to 
classify the device under the criteria set forth in section 513(a)(1). 
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. Under this authority, on 
September 11, 2009, FDA by order classified into class II, subject to 
this special control guidance document, the ovarian adnexal mass 
assessment score test system. Because of the timeframes established by 
section 513(f)(2) of the FD&C 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. Therefore, FDA is issuing this guidance document as 
a level 1 guidance document that is immediately in effect. 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 good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on the ovarian adnexal mass assessment score 
test system. 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. A search capability for all CDRH guidance documents 
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. To receive 
``Class II Special Controls Guidance Document: Ovarian Adnexal Mass 
Assessment Score Test System,'' you may either send an e-mail request 
to dsmica@fda.hhs.gov to receive an electronic copy of the document or 
send a fax request to 301-847-8149 to receive a hard copy. Please use 
the document number 1707 to identify the guidance you are requesting.

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 801 and 21 CFR 809.10 have been approved 
under OMB control number 0910-0485; 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 812 have been 
approved under OMB control number 0910-0078.
    FDA concludes that labeling provisions for the Black Box 
Restrictions of this guidance are not subject to review by the Office 
of Management and Budget because they do not constitute a ``collection 
of information'' under the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3520). Rather, the black box warning on all labeling, advertising, 
and promotional materials for ovarian adnexal mass assessment score 
test system devices is a ``public disclosure of information originally 
supplied by the Federal Government to the recipient for the purpose of 
disclosure to the public.'' (see 5 CFR 1320.3(c)(2)).

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments 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: March 16, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-6622 Filed 3-22-11; 8:45 am]
BILLING CODE 4160-01-P