Document ID: FDA-2011-D-0730-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry and FDA Staff; Class II Special Controls Guidance Documents; Availability: In Vitro Diagnostic Devices for Yersinia Species Detection
Posted Date: 2011-11-07T05:00Z

[Federal Register Volume 76, Number 215 (Monday, November 7, 2011)]
[Notices]
[Pages 69040-69041]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-28725]

  Federal Register / Vol. 76, No. 215 / Monday, November 7, 2011 / 
Notices  

[[Page 69040]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0730]

Draft Guidance for Industry and Food and Drug Administration 
Staff; Class II Special Controls Guidance Document: In Vitro Diagnostic 
Devices for Yersinia Species Detection; 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availability of a draft guidance entitled ``Class II Special Controls 
Guidance Document: In Vitro Diagnostic Devices for Yersinia Species 
Detection.'' This draft guidance document describes a means by which in 
vitro diagnostic devices for Yersinia species (spp.) detection may 
comply with the requirement of special controls for class II devices. 
This draft guidance is not final nor is it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115 (g)(5)), to ensure that the Agency considers your comment on 
this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by February 6, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Class II Special Controls Guidance 
Document: In Vitro Diagnostic Devices for Yersinia spp. Detection'' 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 draft 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: Beena Puri, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave. Bldg. 66, Rm. 5553, Silver Spring, MD 20993-0002, (301) 796-6202.

SUPPLEMENTARY INFORMATION:

I. Background

    Elsewhere in this issue of the Federal Register, FDA is publishing 
a proposed rule to classify in vitro diagnostic devices for Yersinia 
spp. detection into class II (special controls). This draft special 
controls guidance document was developed to support the proposed 
classification of in vitro diagnostic devices for Yersinia spp. 
detection, a previously unclassified preamendments device, into class 
II (special controls). On March 7, 2002, the Microbiology Devices 
Advisory Panel (the panel) recommended that in vitro diagnostic devices 
for Yersinia spp. detection be classified into class II. The panel 
believed that class II with the special controls (guidance document and 
limitations on the distribution) would provide reasonable assurance of 
the safety and effectiveness of the device. After the panel meeting, 
FDA found one additional in vitro diagnostic device for Yersinia spp. 
detection to be substantially equivalent to another device within that 
type. This device has the same intended use as its predicate device but 
makes use of newer nucleic acid amplification technology (NAAT). While 
the NAAT detection devices exhibit technological differences from the 
preamendments Yersinia spp. detection devices, FDA has determined that 
they are as safe and effective as, and do not raise different questions 
of safety and effectiveness than, their predicates. (See section 513(i) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c(i)).)
    This draft guidance document identifies the proposed classification 
regulation, the product code, identifies issues of safety and 
effectiveness that require special controls, and proposes distribution 
limitations. FDA believes that the special controls described in the 
draft guidance when combined with the general controls will be 
sufficient to provide reasonable assurance of the safety and 
effectiveness of these devices.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized will represent the Agency's current thinking on in vitro 
diagnostic devices for Yersinia spp. detection. 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 draft 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: In Vitro Diagnostic 
Devices for Yersinia spp. Detection,'' you may either send an email 
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 1714 to identify the guidance you 
are requesting.

IV. Paperwork Reduction Act of 1995

    This draft 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 (the PRA) (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, and the 
collections of information in 21 CFR part 801 and 21 CFR 809.10 have 
been approved under OMB control number 0910-0485.
    The labeling requirement listed in sections 5 and 8; Intended Use, 
is not subject to review under the PRA because it is a public 
disclosure of information originally supplied by the Federal Government 
to the recipient for the purpose of disclosure to the public (5 CFR 
1320.3(c)(2) and 21 CFR 1040.10(g)).

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.

[[Page 69041]]

    Dated: November 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-28725 Filed 11-4-11; 8:45 am]
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