[Federal Register: July 3, 2007 (Volume 72, Number 127)]
[Rules and Regulations]
[Page 36360-36363]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03jy07-8]
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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