[Federal Register Volume 73, Number 98 (Tuesday, May 20, 2008)]
[Notices]
[Pages 29137-29138]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-11261]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0230]


Guidance for Industry and Food and Drug Administration Staff; 
Class II Special Controls Guidance Document: Plasmodium Species Antigen 
Detection Assays; 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 ``Class II Special Controls 
Guidance Document: Plasmodium Species Antigen Detection Assays.'' This 
guidance document describes a means by which antigen detection assays 
for Plasmodium species may comply with the requirement of special 
controls for class II devices. It includes recommendations for 
validation of performance characteristics and recommendations for 
product labeling. 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 guidance document is immediately in effect as 
the special control for antigen detection assays for Plasmodium 
species, but it remains subject to comment in accordance with the 
agency's good guidance practices.

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: 
Plasmodium Species Antigen Detection Assays'' 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 
to http://www.regulations.gov. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Freddie Poole, Center for Devices and 
Radiological Health (HFZ-440), Food and Drug Administration,2098 
Gaither Rd., Rockville, MD 20850, 240-276-0712.

SUPPLEMENTARY INFORMATION:

I. Background

    Elsewhere in this issue of the Federal Register, FDA is publishing 
a final rule classifying Plasmodium species antigen detection assays 
into class II (special controls) under section 513(f)(2) of the Federal 
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360(c)(f)(2)). This

[[Page 29138]]

guidance document will serve as the special control for Plasmodium 
species antigen detection assays. 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 timeframes 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. 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 (Sec.  10.115). The guidance represents the 
agency's current thinking on ``Plasmodium species antigen detection 
assays.'' 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 ``Class II Special Controls Guidance 
Document: Plasmodium Species Antigen Detection Assays'' you may either 
send an e-mail request to [email protected] 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 1646 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 at http://www.regulations.gov.

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; and the collections of 
information in 21 CFR parts 801 and 809 have been approved under OMB 
control number 0910-0485.

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 submit 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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

    Dated: April 30, 3008.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E8-11261 Filed 5-19-08; 8:45 am]
BILLING CODE 4160-01-S