FDA implantable chips and HR 3200 health bill care

 

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.

––––––––––––––––––––––––

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.

 

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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

 

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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.

 

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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.

 

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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

 

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