[Federal Register Volume 64, Number 44 (Monday, March 8, 1999)]
[Rules and Regulations]
[Pages 10947-10949]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-5516]
-----------------------------------------------------------------------
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.
[[Page 10948]]
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is classifying the
nasal dilator, intranasal splint, and the bone particle collector into
class I (general controls). FDA is also exempting the devices from the
requirements of premarket notification. This action is taken under the
Federal Food, Drug, and Cosmetic Act (the act), as amended by the
Medical Device Amendments of 1976 (the amendments), the Safe Medical
Devices Act of 1990 (SMDA), and the Food and Drug Administration
Modernization Act of 1997 (FDAMA).
EFFECTIVE DATE: April 7, 1999.
FOR FURTHER INFORMATION CONTACT: Harry R. Sauberman, Center for Devices
and Radiological Health (HFZ-470), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-2080.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of May 11, 1998 (63 FR 25794), FDA issued a
proposed rule to classify the nasal dilator, the intranasal splint, and
the bone particle collector into class I (general controls) and to
exempt them from premarket notification procedures based on new
information regarding these devices.
Interested persons were given until August 10, 1998, to comment on
the proposed rule. During the comment period, FDA received one comment
that raised the following three issues about the nasal dilator:
(1) The comment suggested that the intended use of the external
nasal dilator be expanded to also include transient causes for
breathing difficulties in addition to structural abnormalities, such as
nasal congestion due to colds, allergies or vasomotor rhinitis.
FDA agrees that the intended use should be expanded to include
transient causes for breathing difficulties and has revised the final
rule accordingly. FDA does not believe that it is necessary, for
purposes of this rule, to include in the identification of the device
specific disease states or conditions for transient causes for
breathing difficulties.
(2) The comment also proposed the description of the external nasal
dilator be changed to ``The external nasal dilator is constructed from
one or more layers of material upon which a spring material is
attached, with a skin adhesive applied to adhere to the skin of the
nose.''
FDA agrees that this is an appropriate description of the external
nasal dilator and has revised the final rule accordingly.
(3) The comment also proposed that the risks to health for the
external nasal dilator be amended to state that ``the use of the
external nasal dilator presents no plausible risk of ulceration and
subsequent infection of the mucous membranes and such risk would be
more accurately associated only with internal nasal dilators.''
FDA agrees that the risk of possible ulceration and subsequent
infection of the mucous membrane would only apply to the internal nasal
dilator. This does not affect the classification of the device or the
final rule in any way.
II. Conclusion
FDA has concluded that the nasal dilator, the intranasal splint,
and the bone particle collector do not present unreasonable risks to
the public health and that general controls would provide reasonable
assurance of the safety and effectiveness of the devices. FDA also
concludes that in the final rule the identification of the nasal
dilator be revised to ``A nasal dilator is a device intended to provide
temporary relief from transient causes of breathing difficulties
resulting from structural abnormalities and/or transient causes of
nasal congestion associated with reduced nasal airflow.'' FDA notes
that the external nasal dilator is constructed from one or more layers
of material upon which a spring material is attached, with a skin
adhesive applied to adhere to the skin of the nose and that the
potential risk to health of ulceration and subsequent infection apply
only to use of the internal nasal dilator and to use of the internal
dilator.
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) of the act 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 referred to as ``reserved criteria'').
FDA has determined that the devices do not meet the reserved criteria,
and therefore, they are exempt from the premarket notification
requirements. FDA is finalizing the classification of these devices and
the exemption from premarket notification for these devices.
FDA also notes that Sec. 874.9 Limitations of exemptions from
section 510(k) of the act (21 CFR 874.9) requires manufacturers to
submit a premarket notification of any nasal dilator, intranasal
splint, or bone particle collector whose intended use is different from
the intended use of any legally marketed nasal dilator, intranasal
splint, or bone particle collector.
III. Environmental Impact
The agency has determined under 21 CFR 25.34(b) that this
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.
IV. 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).
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 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 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. FDA
is classifying these three devices into class I, the lowest level of
control allowed. As unclassified devices, the devices have already been
subject to the general controls of the act. Under the final rule, they
will now be exempt from premarket notification. Therefore, the agency
certifies that this final rule will not have a significant economic
impact on a substantial number of small entities. Therefore, under the
Regulatory Flexibility Act, no further analysis is required.
[[Page 10949]]
V. 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 under the Paperwork Reduction Act of 1995 is not required.
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, 21 CFR part
874 is 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 transient causes of breathing difficulties
resulting from structural abnormalities and/or transient causes of
nasal congestion associated with reduced nasal airflow. The device
decreases airway resistance and increases nasal airflow. The external
nasal dilator is constructed from one or more layers of material upon
which a spring material is attached, with a skin adhesive applied to
adhere to the skin of the nose; it 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). 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.
3. Section 874.4780 is added to subpart E to read as follows:
Sec. 874.4780 Intranasal splint.
(a) Identification. An intranasal splint is intended to minimize
bleeding and edema and to prevent adhesions between the septum and the
nasal cavity. It is placed in the nasal cavity after surgery or trauma.
The intranasal splint is constructed from plastic, silicone, or
absorbent material.
(b) Classification. Class I (general controls). 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.
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 a 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 premarket notification procedures in subpart E of part 807
of this chapter subject to the limitations in Sec. 874.9.
Dated: March 1, 1999.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-5516 Filed 3-5-99; 8:45 am]
BILLING CODE 4160-01-F