[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
