[Federal Register: September 20, 2005 (Volume 70, Number 181)]
[Rules and Regulations]
[Page 55026-55028]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20se05-2]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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