[Federal Register Volume 71, Number 109 (Wednesday, June 7, 2006)]
[Rules and Regulations]
[Pages 32834-32835]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-8791]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 874

[Docket No. 2006N-0182]


Medical Devices; Ear, Nose, and Throat Devices; Classification of 
Olfactory Test Device

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the 
olfactory test 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: Olfactory Test Device.'' 
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 
announcing the availability of the guidance document that is the 
special control for the device.

DATES: This final rule becomes effective July 7, 2006. The 
classification was effective March 27, 2006.

FOR FURTHER INFORMATION CONTACT: Eric A. Mann, Center for Devices and 
Radiological Health (HFZ-460), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2080.

SUPPLEMENTARY INFORMATION:

I. What is the Background of This Rulemaking?

    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 the 
device is classified or reclassified into class I or class 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 predicate 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 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 notice 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 May 27, 2004, classifying the HealthCheck\TM\ Home Test for 
Loss of the Sense of Smell into class III, because it was not 
substantially equivalent to a class I or class II 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 July 28, 2004, 
FMG Innovations, Inc., submitted a request for classification of the 
HealthCheck\TM\ Home Test for Loss of the Sense of Smell under section 
513(f)(2) of the act (Ref. 1). The manufacturer recommended that the 
device be classified into class I.
    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. In general, 
devices are to be classified into class I if general controls, by 
themselves are sufficient to provide reasonable assurance of safety and 
effectiveness. 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 HealthCheck\TM\ Home Test for Loss of 
the Sense of Smell should be classified into class II with the 
establishment of special controls. FDA believes that special controls, 
in addition to general controls, are necessary to provide reasonable 
assurance of safety and effectiveness of the device, and there is 
sufficient information to establish special controls to provide such 
assurance.
    The device is assigned the generic name ``olfactory test device,'' 
and it is identified as a device used to determine whether a loss of 
olfactory function is present. The device includes one or more odorants 
that are presented to the patient's nose to subjectively assess 
olfactory function (i.e., the patient's ability to perceive odors). 
This device is not intended for the screening or diagnosis of diseases 
or conditions other than the loss of olfactory function.
    FDA has identified the risks to health associated with this type of 
device as failure to detect olfactory sensory loss and user error. FDA 
believes that the class II special controls guidance document will aid 
in mitigating the potential risks to health by providing 
recommendations for the validation of performance characteristics and 
labeling. FDA believes that the special controls guidance document, in 
addition to general controls, addresses

[[Page 32835]]

the risks to health identified previously and provides reasonable 
assurance of the safety and effectiveness of the device. Therefore, on 
March 27, 2006, FDA issued an order to the petitioner classifying the 
device into class II. FDA is codifying this classification at Sec.  
874.1600.
    Following the effective date of the final classification rule, 
manufacturers will need to address the issues covered in this special 
control guidance. However, the manufacturer need only show that its 
device meets the recommendations of the guidance or in some other way 
provides equivalent assurances 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 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 assure the safety and effectiveness of 
olfactory test devices when intended to determine whether an olfactory 
loss is present.

II. What Is the Environmental Impact of This Rule?

    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. What Is the Economic Impact of This Rule?

    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 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 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. Does This Final Rule Have Federalism Implications?

    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.

V. How Does This Rule Comply with the Paperwork Reduction Act of 1995?

    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 (PRA) is not required. FDA 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 
Olfactory Test Device.'' The notice contains an analysis of the 
paperwork burden for the guidance.

VI. What References are on Display?

    The following references have 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 FMG Innovations, Inc., for classification of 
the HealthCheck\TM\ Home Test for Loss of the Sense of Smell 
submitted July 28, 2004.

List of Subjects in 21 CFR Part 874

    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 
874 is amended as follows:

PART 874--EAR, NOSE, AND THROAT DEVICES

0
1. The authority citation for 21 CFR part 874 continues to read as 
follows:

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

0
2. Add Sec.  874.1600 to subpart B to read as follows:


Sec.  874.1600  Olfactory test device.

    (a) Identification. An olfactory test device is used to determine 
whether an olfactory loss is present. The device includes one or more 
odorants that are presented to the patient's nose to subjectively 
assess the patient's ability to perceive odors.
    (b) Classification. Class II (special controls). The special 
control for these devices is the FDA guidance document entitled ``Class 
II Special Controls Guidance Document: Olfactory Test Device.'' For the 
availability of this guidance document, see Sec.  874.1(e). The device 
is exempt from the premarket notification procedures in subpart E of 
part 807 of this chapter subject to the limitations in Sec.  874.9. 
When indicated for the screening or diagnosis of diseases or conditions 
other than the loss of olfactory function, the device is not exempt 
from premarket notification procedures.

    Dated: May 24, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E6-8791 Filed 6-6-06; 8:45 am]
BILLING CODE 4160-01-S