[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