[Federal Register Volume 65, Number 68 (Friday, April 7, 2000)]
[Rules and Regulations]
[Pages 18234-18236]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-8597]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 872

[Docket No. 00P-1209]


Medical Devices; Laser Fluorescence Caries Detection Device

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the 
laser fluorescence caries detection device into class II (special 
controls). The special controls that will apply to this device are set 
forth below. The

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agency is taking this action in response to a petition submitted under 
the Federal Food, Drug, and Cosmetic Act (the act) as amended by the 
Medical Device Amendments of 1976 (the amendments), the Safe Medical 
Devices Act of 1990, and the Food and Drug Administration Modernization 
Act of 1997. The agency is classifying this device into class II 
(special controls) in order to provide a reasonable assurance of safety 
and effectiveness of the device.

DATES: This rule is effective May 8, 2000.

FOR FURTHER INFORMATION CONTACT: Robert S. Betz, Center for Devices and 
Radiological Health (HFZ-480), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-827-5283.

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 513(f)(1) of 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 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 part 807 (21 CFR part 807) of the FDA 
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 FDA to classify the device under the 
criteria set forth in section 513(a)(1) of the act. FDA shall classify 
the device by written order within 60 days of receiving such a request. 
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.
    On December 23, 1999, after review of KaVo America Corp.'s appeal, 
FDA reopened their petition under section 513(f)(2) of the act 
requesting classification of its DIAGNOdent Laser Fluorescence Caries 
Detection Device intended for aiding in the diagnosis of dental caries. 
After review of the information submitted in the petition, its 
amendments, and the original 510(k) notification (K983658), FDA issued 
an order on February 22, 2000, classifying the DIAGNOdent Laser 
Fluorescence Caries Detection Device and substantially equivalent 
devices of this generic type into class II under the generic name 
``laser fluorescence caries detection device.'' FDA has determined that 
the laser fluorescence caries detection device can be classified in 
class II with the establishment of the following special controls:
    1. That sale, distribution, and use of this device are restricted 
to prescription use in accordance with 21 CFR 801.109;
    2. That premarket notifications include clinical studies, or other 
relevant information, that demonstrates that the device aids in the 
detection of tooth decay by measuring increased laser induced 
fluorescence; and
    3. That the labeling must include detailed use instructions with 
precautions that urge users to: (a) Read and understand all directions 
before using the device, (b) store probe tips under proper conditions, 
(c) properly sterilize the emitter-detector handpiece before each use, 
and (d) properly maintain and handle the instrument in the specified 
manner and condition.
    FDA believes that these class II special controls, in addition to 
the general controls, provide reasonable assurance of the safety and 
effectiveness of the device.

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 and the Regulatory Flexibility Act (5 U.S.C. 601-612) (as 
amended by subtitle D of the Small Business Regulatory Fairness Act of 
1996 (Public Law 104-121)), 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 consistent 
with the regulatory philosophy and principles identified in the 
Executive Order. In addition, the final rule is not a significant 
regulatory action as defined by the Executive Order and so it is not 
subject to review 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. 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. FDA knows of only one manufacturer 
of this type of device. Therefore, the agency certifies that this final 
rule will not have a significant impact on a substantial number of 
small entities. In addition, this final rule will not impose costs of 
$100 million or more on either the private sector or State, local, and 
tribal governments in the aggregate, and, therefore, a summary 
statement of analysis under section 202(a) of the Unfunded Mandates 
Reform Act is not required.

IV. 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.

List of Subjects in 21 CFR Part 872

    Medical devices.

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

PART 872--DENTAL DEVICES

    1. The authority citation for 21 CFR part 872 continues to read as 
follows:

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

    2. Section 872.1745 is added to subpart B to read as follows:


Sec. 872.1745  Laser fluorescence caries detection device.

    (a) Identification. A laser fluorescence caries detection device is 
a laser, a fluorescence detector housed in a dental handpiece, and a 
control console that performs device calibration, as well as

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variable tone emitting and fluorescence measurement functions. The 
intended use of the device is to aid in the detection of tooth decay by 
measuring increased laser induced fluorescence.
    (b) Classification. Class II, subject to the following special 
controls:
    (1) Sale, distribution, and use of this device are restricted to 
prescription use in accordance with Sec. 801.109 of this chapter;
    (2) Premarket notifications must include clinical studies, or other 
relevant information, that demonstrates that the device aids in the 
detection of tooth decay by measuring increased laser induced 
fluorescence; and
    (3) The labeling must include detailed use instructions with 
precautions that urge users to:
    (i) Read and understand all directions before using the device,
    (ii) Store probe tips under proper conditions,
    (iii) Properly sterilize the emitter-detector handpick before each 
use, and
    (iv) Properly maintain and handle the instrument in the specified 
manner and condition.

    Dated: March 29, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-8597 Filed 4-6-00; 8:45 am]
BILLING CODE 4160-01-F