[Federal Register Volume 72, Number 127 (Tuesday, July 3, 2007)]
[Rules and Regulations]
[Pages 36360-36363]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-12789]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 880

[Docket No. 2007N-0198 ]


Medical Devices; General Hospital and Personal Use Devices; 
Classification of the Filtering Facepiece Respirator for Use by the 
General Public in Public Health Medical Emergencies

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the 
filtering facepiece respirator for use by the general public in public 
health medical emergencies into class II (special controls). The agency 
is classifying these devices into class II (special controls) in order 
to provide a reasonable assurance of the safety and effectiveness of 
these devices and is specifying what those special controls are.
    Elsewhere in this issue of the Federal Register, FDA is announcing 
the availability of a guidance document entitled, ``Guidance for 
Industry and Food and Drug Administration Staff; Class II Special 
Controls Guidance Document: Filtering Facepiece Respirator for Use by 
the General Public in Public Health Medical Emergencies.'' This 
guidance document will serve as one of the special controls, along with 
certification of the respirator by the National Institute for 
Occupational Safety and Health (NIOSH) in accordance with its 
regulations for non-powered air-purifying particulate respirators, 
found in 42 CFR part 84, as specified in the classification regulation.

DATES: This rule is effective August 2, 2007. The classification was 
effective May 8, 2007.

FOR FURTHER INFORMATION CONTACT: Sheila A. Murphey, Center for Devices 
and Radiological Health (HFZ-480), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 240-276-3700.

SUPPLEMENTARY INFORMATION:

I. What is the Background of this Rulemaking?

    In accordance with section 513(f)(1) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360c(f)(1)), devices that were not in 
commercial distribution before May 28, 1976, the date of enactment of 
the Medical Device Amendments of 1976 (the amendments), generally 
referred to as postamendments devices, are classified automatically by 
statute into class III without any FDA rulemaking process. These 
devices remain in class III and require premarket approval, unless the 
device is classified or reclassified into class I or class II, or FDA 
issues an order finding the device to be substantially equivalent, in 
accordance with section 513(i) of the act, to a predicate device that 
does not require premarket approval. The agency determines whether new 
devices are substantially equivalent to predicate devices by means of 
premarket notification procedures in section 510(k) of the act (21 
U.S.C. 360(k)) and part 807 (21 CFR part 807) of FDA's regulations.
    Section 513(f)(2) of the act provides that any person who submits a 
premarket notification under section 510(k) of the act for a device 
that has not previously been classified may, within 30 days after 
receiving an order classifying the device in class III under section 
513(f)(1) of the act, request FDA to classify the device under the 
criteria set forth in section 513(a)(1) of the act. FDA shall, within 
60 days of receiving such a request, classify the device by written 
order. This classification shall be the initial classification of the 
device type. Within 30 days after the issuance of an order classifying 
the device, FDA must publish a notice in the Federal Register 
announcing such classification (section 513(f)(2) of the act).
    In accordance with section 513(f)(1) of the act, FDA issued an 
order on August 30, 2006, classifying the two 3M filtering facepiece 
respirators intended for use by the general public in public health 
medical emergencies (designated at that time as the 3M\TM\ N95 Home 
Respirator with Fluid Resistance and 3M\TM\ N95 Home Respirator) in 
class III, because each device was not substantially equivalent to a 
device that was introduced or delivered for introduction into 
interstate commerce for commercial distribution before May 28, 1976, or 
a device that was subsequently reclassified into class I or class II. 
On October 3, 2006, 3M Inc. submitted a petition requesting initial 
classification of these devices under section 513(f) (2) of the act. 
The manufacturer recommended that the

[[Page 36361]]

devices be classified into class II (Ref. 1). In response to FDA 
requests for additional information, 3M supplemented its petition on 
March 22, 2007.
    In accordance with section 513(f) (2) of the act, FDA reviewed the 
petition in order to classify the devices under the criteria for 
classification set forth in 513(a)(1) of the act. Devices are to be 
classified into class II if general controls, by themselves, are 
insufficient to provide reasonable assurance of safety and 
effectiveness, but there is sufficient information to establish special 
controls to provide reasonable assurance of the safety and 
effectiveness of the device for its intended use. After review of the 
information submitted in the petition and its supplements, FDA 
determined that the 3M\TM\ filtering facepiece respirator devices, now 
known as the 3M\TM\ 8612F Respirator for Use by the General Public in 
Public Health Medical Emergencies and 3M\TM\ 8670F Respirator for Use 
by the General Public in Public Health Medical Emergencies can be 
classified into class II with the establishment of special controls. 
FDA believes that special controls, in addition to general controls, 
are adequate to provide reasonable assurance of the safety and 
effectiveness of the device and that there is sufficient information to 
establish special controls to provide such assurance.
    The device is assigned the generic name ``Filtering Facepiece 
Respirator for use by the General Public in Public Health Medical 
Emergencies'' and is identified as a device that is a disposable half-
facepiece non-powered air-purifying particulate respirator intended for 
use to cover the nose and mouth of the wearer to help reduce wearer 
exposure to pathogenic biological airborne particulates during a public 
health medical emergency. The device is made of polymeric materials and 
is intended to fit closely to the face and to function by filtering 
particulate material.
    FDA believes that special controls are needed to help address the 
following issues affecting the safety and effectiveness of the 
filtering facepiece respirator for use by the general public in public 
health medical emergencies.

A. Assuring Filtration and Breathability

    For this type of respirator to reduce wearer exposure to pathogenic 
biological airborne particulates, it must be made of filter material 
that is highly efficient in filtering such particles. At the same time, 
because this type of device depends on the wearer's normal respiration 
to draw ambient air through the respirator materials and into the 
lungs, the respirator material must also permit adequate respiration.

B. Assuring Proper Fit

    The device must fit closely to the wearer's face without any gaps 
that would allow air to reach the wearer's respiratory tract without 
passing through the filter material. Otherwise, improper fit of the 
respirator could result in inhalation of pathogenic biological airborne 
particulates carried in air that passes around the sides of the device.

C. Avoiding Adverse Skin Reaction

    Reducing wearer exposure to pathogenic biological airborne 
particulates requires that the device be properly fitted to the face. 
If the respirator material in contact with the skin is not 
biocompatible, it may cause adverse reactions such as redness, 
pruritus, and skin irritation.

D. Assuring Proper Use

    While a filtering facepiece respirator for use by the general 
public in public health medical emergencies can help to reduce wearer 
exposure to pathogenic biological airborne particulates in a public 
health medical emergency where there is a serious risk from such 
exposure, these devices do not provide complete protection against 
infection. Even when used correctly and consistently, a filtering 
facepiece respirator does not eliminate all respiratory exposure, and 
for many pathogens that may be transmitted through airborne 
particulates, transmission via other routes is also possible. (Because 
filtering facepiece respirators for use by the general public in public 
health medical emergencies have not been tested against specific 
microorganisms, the extent of protection to be expected against 
specific pathogens is not known and would vary with particular 
conditions in any event.)
    The respirator should always be used in conjunction with other 
infection control and respiratory protection measures. In addition, 
because the outside of the respirator may be contaminated with 
infectious materials during normal use, proper handling and disposal is 
important to avoid the respirator itself becoming a vector of 
transmission of infectious agents.
    Further, failure of the user to assure proper fit of the respirator 
could result in exposure to pathogenic biological airborne particles. 
Certain populations such as children will be unlikely to achieve a 
proper fit because respirators are designed and sized for adults.
    For users with certain underlying cardiac, pulmonary or related 
medical conditions, achieving the fit necessary to help reduce their 
exposure to pathogenic biological airborne particulates may exacerbate 
their underlying medical conditions raising a concern about their safe 
use for these populations.
    Finally, these respirators have not been established to be safe or 
effective if reused, and use of a single respirator by multiple users 
may result in the respirator itself becoming a vector of transmission.
    To address these issues, the class II special controls guidance 
document provides recommendations for labeling and for information to 
be provided to meet premarket notification (510(k)) submission 
requirements for the device, including recommendations for fit testing 
and biocompatibility testing. In addition, this classification 
regulation specifies another special control, certification of the 
respirator by NIOSH as a non-powered air-purifying particulate 
respirator with a minimum filtration efficiency classification of N95, 
in accordance with 42 CFR part 84. The respirators that were the 
subject of the initial classification order described in this document 
and that are the initial legal predicate devices for this new device 
classification were certified by NIOSH under these requirements, as 
revised as of October 1, 2006. FDA's determination that NIOSH 
certification is an appropriate special control to help assure the 
safety and effectiveness of the respirator for its intended use under 
this classification rests on the assurance of filtration efficiency and 
breathability provided by NIOSH certification under these requirements, 
as effective on May 8, 2007, the date of FDA's classification order. 
Should NIOSH revise the requirements for certification in the future, 
FDA will evaluate whether certification under such revised NIOSH 
regulations is an appropriate special control for devices within this 
classification and may revise FDA's regulation using appropriate 
procedures.
    FDA believes that these special controls, designated in this rule, 
in addition to general controls, address the issues identified 
previously and provide reasonable assurance of the safety and 
effectiveness of the device type. Thus, on May 8, 2007, FDA issued an 
order to the petitioner classifying the device type into class II. FDA 
is codifying this classification at 21 CFR 880.6260.
    Following the effective date of the final classification rule, 
manufacturers will need to demonstrate NIOSH certification of any 
filtering facepiece respirator for use by the general public in public 
health medical emergencies,

[[Page 36362]]

as set forth in 21 CFR 880.6260(b)(1), and address the issues covered 
in the special controls guidance. With respect to the issues addressed 
only in the special control guidance, however, the manufacturer need 
only show that its device meets the recommendations of the guidance or 
in some other way provides equivalent assurance of safety and 
effectiveness.
    Section 510(m) of the act provides that FDA may exempt a class II 
device from the premarket notification requirements under section 
510(k) of the act, if FDA determines that premarket notification is not 
necessary to provide reasonable assurance of the safety and 
effectiveness of the device. For filtering facepiece respirators for 
use by the general public in public health medical emergencies, 
however, FDA has determined that premarket review of fit performance 
data, labeling, and other requirements as outlined in 21 CFR 807.87, is 
necessary to provide reasonable assurance that acceptable levels of 
performance for both safety and effectiveness will be addressed before 
marketing clearance. Thus, persons who intend to market this type of 
device must submit to FDA a premarket notification, prior to marketing 
the device type.

II. What is the Environmental Impact of This Rule?

    The agency has determined under 21 CFR 25.34(b) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Thus, neither an environmental 
assessment nor an environmental impact statement is required.

III. What is the Economic Impact of This Rule?

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and 
the Unfunded Mandates Reform Act of 1995 (Public Law 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 final rule is not a significant regulatory action as defined by 
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. Because classification of this device into class II 
will relieve manufacturers of the cost of complying with the premarket 
approval requirements of section 515 of the act (21 U.S.C. 360e), and 
may permit small potential competitors to enter the marketplace by 
lowering their costs, the agency certifies that the final rule will not 
have a significant economic impact on a substantial number of small 
entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $122 million, using the most current (2005) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
final rule to result in any 1-year expenditure that would meet or 
exceed this amount.

IV. Does This Final Rule Have Federalism Implications?

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, the agency has concluded 
that the rule does not contain policies that have federalism 
implications as defined in the Executive order and, consequently, a 
federalism summary impact statement is not required.

V. How Does This Rule Comply with the Paperwork Reduction Act of 1995?

    This final rule contains no new information collection provisions 
but refers to NIOSH regulations in 42 CFR part 84 that contain 
information collection provisions that have been reviewed and approved 
by the Office of Management and Budget (OMB) under the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3501-3520), under OMB Control No. 
0920-0109. Based on information from NIOSH regarding submissions for 
respirator certification received in the past 3 years, FDA concludes 
that specification of NIOSH certification as a special control will not 
result in the collection of any additional information by NIOSH not 
already covered by NIOSH's burden estimates. This final rule also 
designates a guidance document as a special control. Elsewhere in this 
issue of the Federal Register, FDA is publishing a notice announcing 
the availability of that guidance document, ``Class II Special Controls 
Guidance Document: Filtering Facepiece Respirators for Use by the 
General Public in Public Health Medical Emergencies,'' which contains a 
Paperwork Reduction Act analysis for that guidance.

VI. What References are on Display?

    The following references have been placed on display in the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. Petition from 3M.
    2. 42 CFR part 84, as revised as of October 1, 2006.

List of Subjects in 21 CFR part 880

    Medical devices.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
880 is amended as follows:

PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES

0
1. The authority citation for 21 CFR part 880 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.


0
2. Section 880.6260 is added to subpart G to read as follows:


Sec.  880.6260  Filtering facepiece respirator for use by the general 
public in public health medical emergencies.

    (a) Identification. A filtering facepiece respirator for use by the 
general public in public health medical emergencies is a device that is 
a disposable half-facepiece non-powered air-purifying particulate 
respirator intended for use to cover the nose and mouth of the wearer 
to help reduce wearer exposure to pathogenic biological airborne 
particulates during a public health medical emergency. The device is 
made of polymeric materials and is intended to fit closely to the face 
and to function by filtering particulate material.
    (b) Classification. Class II (special controls). The special 
controls are:
    (1) Certification by the National Institute for Occupational Safety 
and Health (NIOSH) as a non-powered air-

[[Page 36363]]

purifying particulate respirator with a minimum filtration efficiency 
classification of N95, in accordance with 42 CFR part 84.
    (2) The FDA guidance document entitled: ``Guidance for Industry and 
Food and Drug Administration Staff; Class II Special Controls Guidance 
Document: Filtering Facepiece Respirator for use by the General Public 
in Public Health Medical Emergencies.'' See Sec.  880.1(e) for 
information on obtaining a copy of this guidance document.

    Dated: June 22, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-12789 Filed 7-2-07; 8:45 am]
BILLING CODE 4160-01-S