[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