[Federal Register: December 10, 2004 (Volume 69, Number 237)]
[Rules and Regulations]               
[Page 71702-71704]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10de04-7]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 880

[Docket No. 2004N-0477]

 
Medical Devices; General Hospital and Personal Use Devices; 
Classification of Implantable Radiofrequency Transponder System for 
Patient Identification and Health Information

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the 
implantable radiofrequency transponder system for patient 
identification and health information into class II (special controls). 
The special control that will apply to the device is the guidance 
document entitled ``Class II Special Controls Guidance Document: 
Implantable Radiofrequency Transponder System for Patient 
Identification and Health Information.'' The agency is classifying the 
device into class II (special controls) in order to provide a 
reasonable assurance of safety and effectiveness of the device. 
Elsewhere in this issue of the Federal Register, FDA is publishing a 
notice of availability of a guidance document that is the special 
control for this device.

DATES: This rule is effective January 10, 2005. The classification was 
effective October 12, 2004.

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

    In accordance with section 513(f)(1) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360c(f)(1)), devices that were not in 
commercial distribution before May 28, 1976, the date of enactment of 
the Medical Device Amendments of 1976 (the amendments), generally 
referred to as postamendments devices, are classified automatically by 
statute into class III without any FDA rulemaking process. These 
devices remain in class III and require premarket approval, unless and 
until the device is classified or reclassified into class I or II or 
FDA issues an order finding the device to be substantially equivalent, 
in accordance with section 513(i) of the act, to a predicate device 
that does not require premarket approval. The agency determines whether 
new devices are substantially equivalent to previously marketed devices 
by means of premarket notification procedures in section 510(k) of the 
act (21 U.S.C. 360(k)) and 21 CFR part 807 of FDA's regulations.
    Section 513(f)(2) of the act provides that any person who submits a 
premarket notification under section 510(k) of the act 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 that FDA 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 document in the Federal Register announcing 
such classification (section 513(f)(2) of the act).

[[Page 71703]]

    In accordance with section 513(f)(1) of the act, FDA issued a 
document on July 22, 2004, classifying the VERICHIP Health Information 
Microtransponder System in class III, because it was not substantially 
equivalent to a device that was introduced or delivered for 
introduction into interstate commerce for commercial distribution 
before May 28, 1976, or a device which was subsequently reclassified 
into class I or class II. On August 4, 2004, Digital Angel Corp. 
submitted a petition requesting classification of the VERICHIP Health 
Information Microtransponder System under section 513(f)(2) of the act. 
The manufacturer recommended that the device be classified into class 
II (Ref. 1).
    In accordance with section 513(f)(2) of the act, FDA reviewed the 
petition in order to classify the device under the criteria for 
classification set forth in section 513(a)(1) of the act. Devices are 
to be classified into class II if general controls, by themselves, are 
insufficient to provide reasonable assurance of safety and 
effectiveness, but there is sufficient information to establish special 
controls to provide reasonable assurance of the safety and 
effectiveness of the device for its intended use. After review of the 
information submitted in the petition, FDA determined that the VERICHIP 
Health Information Microtransponder System can be classified in class 
II with the establishment of special controls. FDA believes these 
special controls, in addition to general controls, will provide 
reasonable assurance of safety and effectiveness of the device.
    The device is assigned the generic name implantable radiofrequency 
transponder system for patient identification and health information 
and is identified as a system intended to enable access to secure 
patient identification and corresponding health information. This 
system may include a passive implanted transponder, inserter, and 
scanner. The implanted transponder is used only to store a unique 
electronic identification code that is read by the scanner. The 
identification code is used to access patient identity and 
corresponding health information stored in a database.
    The potential risks to health associated with the device are 
adverse tissue reaction, migration of implanted transponder, 
compromised information security, failure of implanted transponder, 
failure of inserter, failure of electronic scanner, electromagnetic 
interference, electrical hazards, magnetic resonance imaging 
incompatibility, and needle stick. The special controls document aids 
in mitigating the risks by identifying performance and safety testing, 
and appropriate labeling.
    Therefore, in addition to the general controls of the act, an 
implantable radiofrequency transponder system for patient 
identification and health information is subject to special controls 
identified as the guidance document entitled ``Class II Special 
Controls Guidance Document: Implantable Radiofrequency Transponder 
System for Patient Identification and Health Information.''
    FDA believes that following the class II special controls guidance 
document generally addresses the risks to health identified in the 
previous paragraph. Therefore, on October 12, 2004, FDA issued an order 
to the petitioner classifying the device into class II. FDA is 
codifying this classification by adding 21 CFR 880.6300.
    Section 510(m) of the act provides that FDA may exempt a class II 
device from the premarket notification requirements under section 
510(k) of the act, if FDA determines that premarket notification is not 
necessary to provide reasonable assurance of the safety and 
effectiveness of the device. FDA has determined that premarket 
notification is not necessary to provide reasonable assurance of the 
safety and effectiveness of the implantable radiofrequency transponder 
system for patient identification and health information because the 
manufacturing controls, software validation science, and electrical 
safety standards in the special control guidance are well known. The 
measures needed to keep patient data secure are commonly in use. Thus, 
persons who intend to market this device type need not submit to FDA a 
premarket notification submission containing information on an 
implantable radiofrequency transponder system for patient 
identification and health information, unless they exceed the 
limitations on exemptions in 21 CFR 880.9 (e.g., different intended use 
or fundamental scientific technology).
    For the convenience of the reader, FDA is also adding new 21 CFR 
880.1 to inform readers of the availability of guidance documents 
referenced in 21 CFR part 880.

II. Environmental Impact

    The agency has determined under 21 CFR 25.34(b) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

III. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the 
Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive 
Order 12866 directs agencies to assess all costs and benefits of 
available regulatory alternatives and, when regulation is necessary, to 
select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this final rule is not a significant regulatory action under the 
Executive order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because classification of these devices into class 
II will relieve manufacturers of the device of the cost of complying 
with the premarket approval requirements of section 515 of the act (21 
U.S.C. 360e), and may permit small potential competitors to enter the 
marketplace by lowering their costs, the agency certifies that the 
final rule will not have a significant impact on a substantial number 
of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $110 million. FDA does not expect this final rule to 
result in any 1-year expenditure that would meet or exceed this amount.

IV. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, the agency has concluded 
that the rule does not contain policies that have federalism 
implications as defined in the Executive order and, consequently, a 
federalism summary impact statement is not required.

[[Page 71704]]

V. Paperwork Reduction Act of 1995

    This final rule contains no collections of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

VI. Reference

    The following reference has been placed on display in the Division 
of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. Petition from Digital Angel Corp., dated August 4, 2004.

List of Subjects in 21 CFR Part 880

    Medical devices.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
880 is amended as follows:

PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES

0
1. The authority citation for 21 CFR part 880 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Section 880.1 is amended by adding new paragraph (e) to read as 
follows:


Sec.  880.1  Scope.

* * * * *
    (e) Guidance documents referenced in this part are available on the 
Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html.


0
3. Section 880.6300 is added to subpart G to read as follows:


Sec.  880.6300  Implantable radiofrequency transponder system for 
patient identification and health information.

    (a) Identification. An implantable radiofrequency transponder 
system for patient identification and health information is a device 
intended to enable access to secure patient identification and 
corresponding health information. This system may include a passive 
implanted transponder, inserter, and scanner. The implanted transponder 
is used only to store a unique electronic identification code that is 
read by the scanner. The identification code is used to access patient 
identity and corresponding health information stored in a database.
    (b) Classification. Class II (special controls). The special 
control is FDA's guidance document entitled ``Class II Special Controls 
Guidance Document: Implantable Radiofrequency Transponder System for 
Patient Identification and Health Information.'' See Sec.  880.1(e) for 
the availability of this guidance document. This device is exempt from 
the premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec.  880.9.

    Dated: November 30, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-27077 Filed 12-9-04; 8:45 am]

BILLING CODE 4160-01-S