[Federal Register: December 10, 2004 (Volume 69, Number 237)]
[Notices]
[Page 71821-71822]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10de04-75]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D-0478]
Guidance for Industry and Food and Drug Administration Staff;
Class II Special Controls Guidance Document: Implantable Radiofrequency
Transponder System for Patient Identification and Health Information;
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: Implantable Radiofrequency Transponder
System for Patient Identification and Health Information.'' This
guidance document describes a means by which an implantable
radiofrequency transponder system for patient identification and health
information may comply with the requirement of special controls for
class II devices. Elsewhere in this issue of the Federal Register, FDA
is publishing a final rule to classify the implantable radiofrequency
transponder system for patient identification and health information
into class II (special controls). This guidance document is immediately
in effect as the special control for the device, 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. General comments on agency guidance documents are welcome 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: Implantable Radiofrequency
Transponder System for Patient Identification and Health Information''
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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: Gail Gantt, Center for Devices and
Radiological Health (HFZ-480), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-1287.
SUPPLEMENTARY INFORMATION:
I. Background
Elsewhere in this issue of the Federal Register, FDA is publishing
a final rule classifying the implantable radiofrequency transponder
system for patient identification and health information 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 the Implantable
Radiofrequency Transponder System for Patient Identification and Health
Information device.
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.
[[Page 71822]]
II. Significance of Guidance
This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on special controls for the implantable
radiofrequency transponder system for patient identification and health
information. 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:
Implantable Radiofrequency Transponder System for Patient
Identification and Health Information'' by FAX, 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 (1541) 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. 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 on the Division of Dockets
Management Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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 Reduction Act of 1995 (the PRA) (44 USC 3501-3520). The
quality system regulation provisions addressed in the guidance have
been approved by OMB under OMB control number 0910-0073. 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
paper 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: November 30, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-27078 Filed 12-9-04; 8:45 am]
BILLING CODE 4160-01-S