[Federal Register: May 20, 2008 (Volume 73, Number 98)]
[Notices]
[Page 29137-29138]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20my08-55]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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 dsmica@fda.hhs.gov 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available
at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html. Guidance documents are also
available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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