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

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.

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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.

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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]

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