
[Federal Register Volume 76, Number 96 (Wednesday, May 18, 2011)]
[Proposed Rules]
[Pages 28688-28689]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-12081]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2011-D-0102]


Draft Guidance for Industry and Food and Drug Administration 
Staff; Class II Special Controls Guidance Document: In Vitro Diagnostic 
Devices for Bacillus Species Detection

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Class II Special Controls 
Guidance Document: In Vitro Diagnostic Devices for Bacillus spp. 
Detection.'' This draft guidance document describes means by which in 
vitro diagnostic devices for Bacillus species (spp.) detection may 
comply with the requirement of special controls for class II devices. 
Elsewhere in this issue of the Federal Register, FDA is publishing a 
proposed rule to classify in vitro diagnostic devices for Bacillus spp. 
detection into class II, subject to special controls. This draft 
guidance is not final nor is it in effect at this time.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 comments on 
this draft guidance before it begins work on the

[[Page 28689]]

final version of the guidance, submit either electronic or written 
comments on the draft guidance by August 16, 2011.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Class II Special Controls Guidance 
Document: In Vitro Diagnostic Devices for Bacillus 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    Submit electronic comments on the draft guidance to http://www.regulations.gov.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

    This draft special controls guidance document was developed to 
support the proposed classification of in vitro diagnostic devices for 
Bacillus spp. detection, a previously unclassified preamendments 
device, into class II (special controls). On March 7, 2002, the 
Microbiology Devices Panel (the Panel) recommended that in vitro 
diagnostic devices for Bacillus 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 three additional in vitro 
diagnostic devices for Bacillus 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 NAAT detection devices 
exhibit technological differences from the preamendments Bacillus 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 and product code and issues of safety and effectiveness that 
require special controls. Elsewhere in this Federal Register, in its 
publication of the proposed classification regulation, FDA is including 
proposed distribution limitations as another special control. FDA 
believes that the special controls described in the draft guidance and 
the proposed regulation when combined with general controls will be 
sufficient to provide reasonable assurance of the safety and 
effectiveness of these devices.

II. Significance of Special Controls Guidance Document

    FDA believes that adherence to the recommendations described in 
this guidance document, if finalized, in addition to general controls, 
and the special control in the proposed rule, if finalized, will 
provide reasonable assurance of the safety and effectiveness of in 
vitro diagnostic devices for Bacillus spp. detection classified under 
Sec.  866.3045 (21 CFR 866.3045). If classified as a class II device 
under Sec.  866.3045, an in vitro diagnostic device for Bacillus spp. 
detection will need to comply with the requirement for special 
controls; manufacturers will need to address the issues requiring 
special controls as identified in the guidance document or by some 
other means that provides equivalent assurances of safety and 
effectiveness as well as comply with any additional controls specified 
in the classification regulation itself.

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 Bacillus spp. Detection,'' 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 1667 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 Section 8A, ``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.

    Dated: May 12, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-12081 Filed 5-17-11; 8:45 am]
BILLING CODE 4160-01-P


