[Federal Register: October 26, 2005 (Volume 70, Number 206)]
[Notices]
[Page 61829-61830]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26oc05-107]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005D-0392]
Guidance for Industry and Food and Drug Administration Staff;
Class II Special Controls Guidance Document: Cystic Fibrosis
Transmembrane Conductance Regulator Gene Mutation Detection Systems;
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 document entitled ``Class II Special
Controls Guidance Document: CFTR Gene Mutation Detection Systems.''
This guidance document describes a means by which cystic fibrosis
transmembrane conductance regulator (CFTR) gene mutation detection
systems may comply with the requirements 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 CFTR gene mutation detection systems into class II (special
controls). This guidance document is immediately in effect as the
special control for CFTR gene mutation detection systems, 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.
ADDRESSES: Submit written requests for single copies on a 3.5''
diskette of the guidance document entitled ``Class II Special Controls
Guidance Document: CFTR Gene Mutation Detection Systems'' 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 301-443-8818. 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.fda.gov/dockets/ecomments. Identify comments with the
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Zivana Tezak, Center for Devices and
Radiological Health (HFZ-440), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 240-276-0597.
SUPPLEMENTARY INFORMATION:
I. Background
Elsewhere in this issue of the Federal Register, FDA is publishing
a final rule classifying CFTR gene mutation detection systems into
class II (special controls) under section 513(f)(2) of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360c(f)(2)). This
guidance document will serve as the special control for CFTR gene
mutation detection systems. 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 GGPs regulation
(Sec. 10.115). The guidance represents the agency's current thinking
on CFTR gene mutation detection systems. 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
To receive ``Class II Special Controls Guidance Document: CFTR Gene
Mutation Detection Systems'' by fax machine, call the CDRH Facts-On-
Demand system at 800-899-0381 or 301-827-0111 from a touch-tone
telephone. Press 1 to enter the system. At the second voice prompt,
press 1 to order a document. Enter the document number (1564) followed
by the pound sign (). Follow the remaining voice prompts to
complete your request.
Persons interested in obtaining a copy of the guidance may also do
so by using the Internet. The Center for Devices and Radiological
Health (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 on the Division of Dockets Management Internet site at http://www.fda.gov/ohrms/dockets
.
IV. Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork
[[Page 61830]]
Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). The collections
of information addressed in the guidance document have been approved by
OMB in accordance with the PRA under the regulations governing
premarket notification submissions (21 CFR part 807, subpart E, OMB
control number 0910-0120). The labeling provisions addressed in the
guidance have been approved by OMB 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 two paper
copies of any mailed comments, except that individuals may submit one
copy. Comments are to be identified with the docket number found in
brackets in the heading of this document. Comments received may be seen
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: October 17, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 05-21349 Filed 10-25-05; 8:45 am]
BILLING CODE 4160-01-S