[Federal Register Volume 63, Number 214 (Thursday, November 5, 1998)]
[Rules and Regulations]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 98-29569]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 872
[Docket No. 98P-0731]
Dental Devices; Classification of Sulfide Detection Device
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
SUMMARY: The Food and Drug Administration (FDA) is classifying the
sulfide detection device into class II (special controls). The special
controls that will apply to the sulfide detection device are
restriction to prescription use, conformance with recognized standards
relating to biocompatibility, electrical safety and sterility,
submission of performance data from analytical and clinical studies
demonstrating device effectiveness and adherence to specific labeling
requirements. The 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 Safe
Medical Devices Act of 1990, and the Food and Drug Modernization Act of
1997. The agency is classifying sulfide detection devices into class II
(special controls) in order to provide a reasonable assurance of safety
and effectiveness of the device.
EFFECTIVE DATE: December 7, 1998.
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.
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 the enactment of the Medical Device
Amendments 1976, generally referred to as postamendments devices are
classified automatically by statute into class III without any
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 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). FDA shall, within 60 days of
receiving such as 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 notice in the Federal Register announcing such
In accordance with section 513(f)(1) of the act, FDA issued an
order on May 15, 1998, classifying sulfide detection devices in class
III. On May 18, 1998, Diamond General Development Corp. submitted a
petition requesting classification into class II of the Diamond
Probe/Perio 2000 System that is intended to measure
periodontal pocket probing depths, evaluate the presence or absence of
bleeding on probing, and to detect the presence of sulfides in
periodontal pockets of adult patients. After reviewing the information
submitted in the petition, its amendments, K980749, and medical
literature, FDA concludes that this device, and substantially
equivalent devices of this generic type, can be classified into class
II with the establishment of special controls. 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 the safety and effectiveness of the device and there is
sufficient information to develop special controls to provide such
assurance. After reviewing the information submitted in the petition,
FDA determined that sulfide detection devices can be classified into
class II with the establishment of special controls. FDA believes that
general controls and special controls will provide reasonable assurance
of safety and effectiveness of the device.
FDA has identified the following risks to health associated with
this type of device: (1) Risks associated with the inability to develop
adequate directions for use; (2) risks associated with
biocompatibility, electrical safety, and sterility; (3) risks related
to inaccurate device performance; and (4) risks associated with
improper device use.
FDA determined that the special controls described below address
these risks and provide reasonable assurance of the safety and
effectiveness of the device. Therefore on July 17, 1998, FDA issued an
order to the petitioner classifying the sulfide detection device as
described previously into class II subject to the special controls
Additionally, FDA is codifying the classification of this device by
adding Sec. 872.1870 Sulfide detection device.
In addition to the general controls of the act, the sulfide
detection device is subject to the following special controls which,
combined with general controls, provide reasonable assurance of the
safety and effectiveness of the device: (1) Restriction of the sale,
distribution, and use of this device to prescription use in accordance
with 21 CFR 801.109; (2) conformance with recognized standards for
biocompatibility, electrical safety, and sterility; (3) clinical and
analytical testing sufficient to demonstrate that the device accurately
measures probing depths, detects the presence or absence of bleeding on
probing, and accurately detects the presence of sulfides in periodontal
pockets in adult patients; (4) labeling that includes proper
instructions for device storage, use, and maintenance.
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 efficacy of
the device. FDA has determined premarket notification is necessary to
provide reasonable assurance of the safety and effectiveness of the
device, and therefore, the device is not exempt from the premarket
notification requirements. Thus persons who intend to market this
device must submit to FDA a premarket notification prior to marketing
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 this 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 Flexibility Act
(Pub. L. 104-121), and the Unfunded Mandates Reform Act of 1995 (Pub.
L. 104-4). Executive Order 12866 directs agencies to assess all costs
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 in 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 therefore, certifies
that the 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 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.
The following references have been placed on display in the Dockets
Management Branch (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 Diamond General Development Corp., dated May
2. Solis-Gaffar, M. C., T. Fischer, and A. Gaffar,
``Instrumental Evaluation of Odor Produced by Specific Oral
Microorganisms,'' Journal of Cosmetic Chemistry, vol. 30, pp. 241 to
3. Solis-Gaffar, M. C., K. N. Rustogi, and A. Gaffar, ``Hydrogen
Sulfide Production from Gingival Crevicular Fluid,'' Journal of
Periodontology, vol. 5 (10), pp. 603 to 606, 1980.
List of Subjects in 21 CFR Part 872
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
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
2. Section 872.1870 is added to subpart B to read as follows:
Sec. 872.1870 Sulfide detection device.
(a) Identification. A sulfide detection device is a device
consisting of an AC-powered control unit, probe handle, probe tips,
cables, and accessories. This device is intended to be used in vivo, to
manually measure periodontal pocket probing depths, detect the presence
or absence of bleeding on probing, and detect the presence of sulfides
in periodontal pockets, as an adjunct in the diagnosis of periodontal
diseases in adult patients.
(b) Classification. Class II (special controls) prescription use in
accordance with Sec. 801.109 of this chapter; conformance with
recognized standards of biocompatibility, electrical safety, and
sterility; clinical and analytical performance testing, and proper
Dated: August 25, 1998.
Director, Center for Devices and Radiological Health.
[FR Doc. 98-29569 Filed 11-4-98; 8:45 am]
BILLING CODE 4160-01-F