[Federal Register Volume 70, Number 181 (Tuesday, September 20, 2005)]
[Rules and Regulations]
[Pages 55026-55028]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-18656]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 872

[Docket No. 2005N-0338]


Medical Devices; Dental Devices; Classification of Oral Rinse to 
Reduce the Adhesion of Dental Plaque

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the oral 
rinse to reduce the adhesion of dental plaque device 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: Oral Rinse to Reduce the Adhesion of Dental Plaque.'' 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 October 20, 2005. The reclassification 
was effective March 28, 2005.

FOR FURTHER INFORMATION CONTACT: Robert Betz, Center for Devices and 
Radiological Health (HFZ-410), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-827-5283, ext. 125.

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

[[Page 55027]]

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 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 document in the Federal Register announcing 
such classification (section 513(f)(2) of the act).
    In accordance with section 513(f)(1) of the act, FDA issued an 
order on January 14, 2005, classifying the Decapinol Oral Rinse into 
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 January 24, 
2005, Sinclair Pharmaceuticals submitted a petition requesting 
classification of the Decapinol Oral Rinse under section 513(f)(2) of 
the act. The manufacturer recommended that the device be classified 
into class II (Ref. 1).
    In accordance with 513(f)(2) of the act, FDA reviewed the petition 
in order to classify the device under the criteria for classification 
set forth in 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 Decapinol Oral Rinse can be classified 
into class II with the establishment of special controls. FDA believes 
these special controls, in addition to general controls, will provide 
reasonable assurance of the safety and effectiveness of the device.
    The device is assigned the generic name oral rinse to reduce the 
adhesion of dental plaque and is identified as a device intended to 
reduce the presence of bacterial plaque on teeth and oral mucosal 
surfaces by physical means. The device type includes those devices that 
act by reducing the attachment and inhibiting the growth of bacterial 
plaque.
    FDA has identified the following risks to health associated 
specifically with this type of device: (1) Ineffective plaque 
reduction, (2) alteration of oral flora, (3) adverse tissue reaction, 
(4) toxicity, and (5) improper use. The class II special controls 
guidance document aids in mitigating potential risks by providing 
recommendations on material characterization; validation of performance 
characteristics; testing and control methods; biocompatibility testing; 
and labeling. Therefore, on March 28, 2005, FDA issued an order to the 
petitioner classifying the device into Class II. FDA is codifying this 
device by adding Sec.  872.5580.
    Following the effective date of this final classification rule, any 
firm submitting a 510(k) premarket notification for oral rinse to 
reduce the adhesion of dental plaque will need to address the issues 
covered in the special controls guidance. However, the firm need only 
show that its device meets the recommendations of the guidance, or in 
some other way provides equivalent assurance of safety and 
effectiveness.
    Section 510(m) of the act provides that FDA may exempt a class II 
device from the premarket notification requirements under 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. For this type of device, however, FDA has determined that 
premarket notification is necessary to provide reasonable assurance of 
the safety and effectiveness of this type of device and, therefore, the 
device is not exempt from premarket notification requirements. Thus, 
persons who intend to market this type of device must submit to FDA a 
premarket notification, prior to marketing the device, which contains 
information about the oral rinse to reduce the adhesion of dental 
plaque they intend to market.

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), and 
the Unfunded Mandates Reform Act of 1995 (Pub. L. 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 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. Because classification of this device 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 economic 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 $115 million, using the most current (2003) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
final rule to result in any 1-year expenditure that would meet or 
exceed this amount.

IV. Paperwork Reduction Act of 1995

    FDA concludes that this final rule contains no collections of 
information. Therefore, clearance by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44 
U.S.C. 3501-3520) is not required.

[[Page 55028]]

    FDA also concludes that the special controls guidance document 
contains information collection provisions that are subject to review 
and clearance by OMB under the PRA. Elsewhere in this issue of the 
Federal Register, FDA is publishing a notice announcing the 
availability of the guidance document entitled ``Class II Special 
Controls Guidance Document: Oral Rinse to Reduce the Adhesion of Dental 
Plaque''; the notice contains an analysis of the paperwork burden for 
the guidance.

V. 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 Sinclair Pharmaceuticals, dated January 24, 2005.

List of Subjects in 21 CFR Part 872

    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 
872 is amended as follows:

PART 872--DENTAL DEVICES

0
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.

0
2. Section 872.5580 is added to subpart F to read as follows:


Sec.  872.5580  Oral rinse to reduce the adhesion of dental plaque.

    (a) Identification. The device is assigned the generic name oral 
rinse to reduce the adhesion of dental plaque and is identified as a 
device intended to reduce the presence of bacterial plaque on teeth and 
oral mucosal surfaces by physical means. The device type includes those 
devices that act by reducing the attachment and inhibiting the growth 
of bacterial plaque.
    (b) Classification. Class II (special controls). The special 
control is FDA's guidance document entitled ``Class II Special Controls 
Guidance Document: Oral Rinse to Reduce the Adhesion of Dental 
Plaque.'' See Sec.  872.1(e) for the availability of this guidance 
document.

    Dated: September 9, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 05-18656 Filed 9-19-05; 8:45 am]
BILLING CODE 4160-01-S