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[Federal Register Volume 63, Number 90 (Monday, May 11, 1998)]
[Proposed Rules]
[Pages 25794-25796]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-12312]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 874

[Docket No. 98N-0249]

Ear, Nose, and Throat Devices; Classification of the Nasal 
Dilator, the Intranasal Splint, and the Bone Particle Collector

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to 
classify the nasal dilator, intranasal splint, and the bone particle 
collector into class I and exempt these devices from premarket 
notification procedures. FDA is also publishing the recommendations of 
the Ear, Nose, and Throat Devices Panel (the panel) regarding the 
classification of the devices. After considering public comments on the 
proposed classifications, FDA will publish a final regulation 
classifying the devices. This action is being taken under the Federal 
Food, Drug, and Cosmetic Act (the act), as amended by the Medical 
Device Amendments of 1976 (the 1976 amendments), the Safe Medical 
Devices Act of 1990 (the SMDA), and the Food and Drug Administration 
Modernization Act of 1997 (FDAMA).

DATES: Written comments by August 10, 1998.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Harry R. Sauberman, Center for Devices 
and Radiological Health (HFZ-420), Food and Drug Administration, 9200 
Corporate Blvd, Rockville, MD 20850, 301- 594-2080.

SUPPLEMENTARY INFORMATION:

I. Background

    The act, as amended by the 1976 amendments (Pub. L. 94-295), the 
SMDA (Pub. L. 101-629), and FDAMA (Pub. L. 105-115), established a 
comprehensive system for the regulation of medical devices intended for 
human use. Section 513 of the act (21 U.S.C. 360c) established three 
categories (classes) of devices, depending on the regulatory controls 
needed to provide reasonable assurance of their safety and 
effectiveness. The three categories of devices are class I (general 
controls), class II (special controls), and class III (premarket 
approval). Under section 513 of the act, devices that were in 
commercial distribution before May 28, 1976 (the date of enactment of 
the amendments) are classified after FDA has: (1) Received a 
recommendation from a device classification panel (an FDA advisory 
committee), (2) published the panel's recommendations for comment, 
along with a proposed regulation classifying the device, and (3) 
published a final regulation classifying the device. A device that is 
first offered in commercial distribution after May 28, 1976, and which 
FDA determines to be substantially equivalent to a device classified 
under this scheme, is classified into the same class as the device to 
which it is substantially equivalent. The agency determines whether new 
devices are substantially equivalent to previously offered 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 regulations.
    A device that was not in commercial distribution prior to May 28, 
1976, and that has not been found by FDA to be substantially equivalent 
to a legally marketed predicate device, is classified automatically by 
statute (section 513(f) of the act) into class III without any FDA 
rulemaking process.
    In the Federal Register of November 6, 1986 (51 FR 40378), FDA 
published a final rule classifying ear, nose and throat devices. At 
that time, FDA was not aware that the nasal dilator, the intranasal 
splint, and the bone particle collector were preamendments devices and 
inadvertently omitted classifying them.

II. Device Descriptions

    FDA is proposing the following device descriptions based on the 
panel's recommendations (Ref. 1) and the agency's review:
    (1) The nasal dilator is a device intended to provide temporary 
relief from breathing difficulties resulting from structural 
abnormalities in the nose. The external nasal dilator is described as a 
device constructed from layers of fabric material with a flat plastic 
spring inserted between the layers, with a skin adhesive applied to 
adhere to the skin of the nose. The device is placed externally on the 
lower third of the nose. The external nasal dilator acts with a pulling 
force to open the nares and the nasal valves thereby decreasing nasal 
airway resistance and increasing nasal air flow. The internal nasal 
dilator is constructed from metal or plastic and is placed inside the 
nostrils. It acts by pushing the nostrils open or by gently pressing on 
the columella, thereby decreasing nasal airway resistance and 
increasing nasal airflow;
    (2) The intranasal splint is a device intended to minimize bleeding 
and edema and to prevent adhesions between the septum and the nasal 
cavity. The intranasal splint is constructed from plastic, silicone, or 
absorbent material and is placed in the nasal cavity after surgery or 
trauma; and
    (3) The bone particle collector is a filtering device intended to 
be inserted into the suction tube line during the early stages of 
otologic surgery to collect bone particles for future use.

III. Recommendations of the Panel

    In a public meeting held on October 25, 1990, the panel made 
classification recommendations for the nasal dilator, the intranasal 
splint, and the bone particle collector. The panel recommended that the 
devices be classified in class I (general controls). No recommendation 
was made to exempt these devices.

IV. Summary of the Reasons for the Recommendations

    The panel concluded that the safety and effectiveness of the nasal 
dilator, intranasal splint, and bone particle collector can be 
reasonably assured by general controls. Specifically, the panel 
believed that the safety and effectiveness of the nasal dilator,

[[Page 25795]]

intranasal splint, and the bone particle collector can be reasonably 
assured by: (1) Registration and listing (section 510 of the act), and 
(2) the general requirements concerning reports (21 CFR 820.180), 
complaint files (21 CFR 820.198), and good manufacturing practices 
requirements (section 520(f) of the act (21 U.S.C. 360j(f)).

V. Risks to Health

    The panel identified no specific risks associated with the use of 
the intranasal splint or the bone particle collector. The panel 
identified two potential risks to health associated with use of the 
nasal dilator: (1) The device could be lost inside a wide nose 
(internal dilator), and (2) the device can cause ulceration of skin or 
mucous membrane which could lead to infection. The panel further 
concluded that the risk of injury resulting from a dislodged dilator or 
from skin ulceration is low.

VI. Summary of the Data Upon Which the Proposed Recommendation Is 
Based

    The panel based its recommendations on expert testimony presented 
to the panel and on the panel members' personal knowledge of and 
clinical experience with the nasal dilator, the intranasal splint, and 
the bone particle collector.

VII. FDA's Tentative Finding

    FDA tentatively concurs with the recommendations of the panel that 
the nasal dilator, the intranasal splint, and the bone particle 
collector should be classified into class I (general controls) because 
the agency believes that sufficient information exists to determine 
that general controls will provide reasonable assurance of the safety 
and effectiveness of the devices. Consistent with the purpose of the 
act, class I (general controls) as defined by section 513(a)(1)(A) of 
the act would provide the least amount of regulation necessary to 
reasonably assure that current and future nasal dilators, intranasal 
splints, and bone particle collectors are safe and effective.
    On November 21, 1997, the President signed FDAMA into law. Section 
206 of FDAMA, in part, added a new section 510(l) to the act (21 U.S.C. 
360(l)). Under section 501 of FDAMA, new section 510(l) became 
effective on February 19, 1998. New section 510(l) provides that a 
class I device is exempt from the premarket notification requirements 
under section 510(k) of the act, unless the device is intended for a 
use which is of substantial importance in preventing impairment of 
human health or it presents a potential unreasonable risk of illness or 
injury (hereafter ``reserved criteria''). FDA has determined that these 
devices do not meet the reserved criteria and, therefore, they are 
exempt from the premarket notification requirements.
    The agency, therefore, proposes to classify the nasal dilator, the 
intranasal splint, and the bone particle collector into class I, and to 
exempt them from the premarket notification requirements .

VIII. Reference

    The following reference has been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. Ear, Nose, and Throat Devices Panel, 35th meeting, transcript 
and meeting minutes, October 25-26, 1990.

IX. Environmental Impact

    The agency has determined under 21 CFR 25.34(b) that this proposed 
classification 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.

X. Analysis of Impacts

    FDA has examined the impacts of the proposed 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 (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 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 proposed rule is consistent with 
the regulatory philosophy and principles identified in the Executive 
Order. In addition, the proposed 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. As noted previously, FDA may classify devices into 
one of three regulatory classes according to the degree of control 
needed to provide reasonable assurance of safety and effectiveness. For 
these three devices, FDA is proposing that they be classified into 
class I, the lowest level of control allowed. In addition, FDA is 
proposing to exempt them from premarket notification requirements. 
These devices would be subject to a minimal level of control. The 
agency, therefore, certifies that the proposed rule will not have a 
significant economic impact on a substantial number of small entities. 
In addition, this proposed 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.

XI. Paperwork Reductions Act of 1995

    FDA tentatively concludes that this proposed 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.

XII. Comments

    Interested persons may, on or before August 10, 1998, submit to the 
Dockets Management Branch (address above) written comments regarding 
this proposal. Two copies of any comments are to be submitted except 
that individuals may submit one copy. Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. Received comments may be seen in the office above between 9 
a.m. and 4 p.m., Monday through Friday.

List of Subjects in 21 CFR Part 874

    Medical devices.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR part 874 be amended as follows:

PART 874--EAR, NOSE, AND THROAT DEVICES

    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.

    2. Section 874.3900 is added to subpart D to read as follows:

Sec. 874.3900   Nasal dilator.

    (a) Identification. A nasal dilator is a device intended to provide 
temporary relief from breathing difficulties resulting from structural 
abnormalities in the nose. These devices decrease airway resistance and 
increase nasal airflow. The external nasal dilator is

[[Page 25796]]

constructed from layers of fabric material with a flat plastic string 
inserted between the layers, with a skin adhesive applied to adhere to 
the skin of the nose. The external dilator acts with a pulling action 
to open the nares. The internal nasal dilator is constructed from metal 
or plastic and is placed inside the nostrils. It acts by pushing the 
nostrils open or by gently pressing on the columella.
    (b) Classification. Class I (general controls). This device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter.
    3. Section 874.4780 is added to subpart E to read as follows:

Sec. 874.4780  Intranasal splint.

    (a) Identification. An intranasal splint is a device intended to 
minimize bleeding and edema to prevent adhesions between the septum and 
the nasal cavity. The intranasal splint is constructed between the 
septum and the nasal cavity. The intranasal splint is constructed from 
plastic, silicone, or absorbent material and is placed in the nasal 
cavity after surgery or trauma.
    (b) Classification. Class I (general controls). The device is 
exempted from the premarket notification procedures in subpart E of 
part 807 of this chapter.
    4. Section 874.4800 is added to subpart E to read as follows:

Sec. 874.4800  Bone particle collector.

    (a) Identification. A bone particle collector is a filtering device 
intended to be inserted into the suction tube during the early stages 
of otologic surgery to collect bone particles for future use.
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter.

    Dated: May 1, 1998.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 98-12312 Filed 5-8-98; 8:45 am]
BILLING CODE 4160-01-F
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