[Federal Register Volume 72, Number 38 (Tuesday, February 27, 2007)]
[Proposed Rules]
[Pages 8643-8652]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-3253]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 868
[Docket No. 2007N-0019]
Medical Devices; Anesthesiology Devices; Oxygen Pressure
Regulators and Oxygen Conserving Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is publishing a
proposed rule to reclassify pressure regulators for use with medical
oxygen, currently class I devices included in the generic type of
device called pressure regulator, into class II, subject to special
controls in the form of a guidance document. Pressure regulators for
use with all other medical gases will remain in class I, subject only
to general controls. FDA is also proposing to establish a separate
classification regulation for oxygen conserving devices (or oxygen
conservers), now included in the generic type of device called
noncontinuous ventilator. Oxygen conserving devices will continue to be
classified in class II, but those that incorporate a built-in oxygen
pressure regulator will become subject to the special controls guidance
if the rule is finalized. Elsewhere in this issue of the Federal
Register, FDA is announcing the availability of a class II special
controls draft guidance for industry and FDA staff entitled ``Class II
Special Controls Guidance Document: Oxygen Pressure Regulators and
Oxygen Conserving Devices.'' The agency is proposing this action
because it believes that special controls are necessary to provide a
reasonable assurance of safety and effectiveness for these devices.
DATES: Submit comments by May 29, 2007. FDA is proposing that any final
rule based on this proposed rule be effective 2 years after the date of
its publication in the Federal Register.
ADDRESSES: You may submit comments, identified by Docket No. 2007N-
0019, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following ways:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Agency Web site: http://www.fda.gov/dockets/ecomments.
Follow the instructions for submitting comments on the agency Web site.
Written Submissions
Submit written submissions in the following ways:
FAX: 301-827-6870.
Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal or the agency Web site, as described in the
ADDRESSES portion of this document under Electronic Submissions.
Instructions: All submissions must include the agency name and
Docket No. for this rulemaking. All comments received may be posted
without change to http://www.fda.gov/ohrms/dockets/default.htm,
including any personal information provided. For additional information
on submitting comments, see section XII ``What if I Have Comments to
the Proposed Rule'' heading in the SUPPLEMENTARY INFORMATION section of
this document.
Docket: For access to the docket to read background documents or
comments received, go to http://www.fda.gov/ohrms/dockets/default.htm
and insert the docket number, found in brackets in the heading of this
document, into the ``Search'' box and follow the prompts and/or go to
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Christy Foreman, Center for Devices
and Radiological Health (HFZ-340), Food and Drug Administration, 2094
Gaither Rd., Rockville, MD 20850, 240-276-0120.
SUPPLEMENTARY INFORMATION:
I. What Are the Highlights of the Proposed Rule?
The highlights of the proposed rule are as follows:
FDA is dividing the classification of pressure regulators
into two classification regulations.
Pressure regulators for use with medical gases other than
oxygen will remain in class I.
Pressure regulators for use with medical oxygen will be
identified as ``oxygen pressure regulators'' and will be reclassified
into class II (special controls).
FDA is establishing a separate classification regulation
for oxygen conserving devices, which are now included in the generic
type of device called noncontinuous ventilators.
Both noncontinuous ventilators and oxygen conserving
devices will remain in class II.
Oxygen conservers will be classified within their own
class according to whether or not the device incorporates a built-in
oxygen pressure regulator.
FDA is establishing a special controls guidance document
for oxygen pressure regulators and oxygen conservers that have built-in
oxygen pressure regulators entitled ``Class II Special Controls
Guidance Document: Oxygen Pressure Regulators and Oxygen
[[Page 8644]]
Conserving Devices.'' The main component of the special control
guidance will be the American Society of Standards and Materials (ASTM
International) Standard G175-03, ``Standard Test Method for Evaluating
the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used
for Medical and Emergency Applications,'' published May 2003.
Manufacturers of oxygen pressure regulators that meet the
ASTM standard must label the device ``[c]onforms with ASTM G175-03.''
Manufacturers of oxygen conservers with a built-in oxygen
pressure regulator that meet the ASTM standard must label the oxygen
conserver ``[b]uilt-in oxygen pressure regulator conforms with ASTM
G175-03.''
Manufacturers of oxygen pressure regulators that meet ASTM
G175-03 will be exempt from the premarket notification (510(k))
(section 510(k) of the act (21 U.S.C. 360(k))) requirements, subject to
the limitations of exemption in Sec. 868.9 (21 CFR 868.9).
Manufacturers of oxygen pressure regulators that do not
conform with ASTM G175-03 will be required to submit 510(k)s for their
devices and demonstrate that the alternate measures they follow to
address the risks identified in the guidance document provide
equivalent assurances of safety and effectiveness.
Although all oxygen conservers will continue to require
510(k) clearance, manufacturers of oxygen conservers with a built-in
oxygen pressure regulator may choose to submit an Abbreviated 510(k).
This will allow them to address the risks to health associated with use
of oxygen pressure regulators by certifying conformance with ASTM G175-
03.
II. Which Devices Does the Proposed Rule Affect?
The proposed rule would reclassify pressure regulators that are
intended to be used with medical oxygen, currently classified under 21
CFR 868.2700 (Pressure regulator). In addition, the proposed rule would
create a separate classification regulation for oxygen conserving
devices, currently classified under 21 CFR 868.5905 (Noncontinuous
ventilator).
A pressure regulator, sometimes called a pressure-reducing valve,
is a medical device used to convert medical gas pressure from a high
variable pressure to a lower, more constant working pressure. To
illustrate, medical gas is packaged in high pressure cylinders. The gas
is released through a part of the cylinder called the post-valve, which
functions as an on/off mechanism. When the valve is opened, the
cylinder begins to depressurize and medical gas is released at a very
high rate of speed. To reduce the pressure and control the gas flow, a
pressure regulator is affixed to the post-valve, enabling the user to
safely deliver medical gas from the cylinder. This group of devices
currently includes pressure regulators for use with medical oxygen.
A noncontinuous ventilator is a device intended to deliver
intermittently an aerosol to a patient's lungs or to assist a patient's
breathing. Because these devices deliver medical gas to a patient only
when needed, they function to conserve the medical gas as well. This
group of devices currently includes oxygen conserving devices.
III. What Is the Legal Authority for This Proposed Rule?
The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321
et seq.), as amended by the Medical Devices Amendments of 1976 (the
amendments) (Public Law 94-295), the Safe Medical Devices Act of 1990
(SMDA) (Public Law 101-629), the Food and Drug Administration
Modernization Act of 1997 (FDAMA) (Public Law 105-115), the Medical
Device User Fee and Modernization Act of 2002 (MDUFMA) (Public Law 107-
250), and the Medical Devices Technical Corrections Act (MDTCA) (Public
Law 108-214), establishes a comprehensive system for the regulation of
medical devices intended for human use. Section 513 of the act (21
U.S.C. 360c) establishes three classes of devices, class I (general
controls), class II (special controls), and class III (premarket
approval). Device classifications depend on the regulatory controls
needed to provide reasonable assurance of safety and effectiveness.
Class I devices are devices for which general controls are
sufficient to provide reasonable assurance of safety and effectiveness
(section 513(a)(1)(A) of the act). Class II devices cannot be
classified in class I because 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 such assurance. Special controls may include
performance standards, postmarket surveillance, patient registries, the
development and dissemination of guidelines, and other measures the
agency deems necessary (section 513(a)(1)(B) of the act). Class III
devices require each manufacturer of the device to submit to FDA a
premarket approval application that includes information concerning the
safety and effectiveness of the device (section 513(a)(1)(C) of the
act).
Under section 513(e)(1) of the act, based on new information
respecting a device, the agency may, on its own initiative, by
regulation change a device's classification. The new information needs
to demonstrate that either more regulatory control is needed to provide
reasonable assurance of the device's safety and effectiveness or that
less regulatory control is sufficient to provide such assurance. Based
on the new information discussed in section V of this document, FDA
believes that reclassifying pressure regulators for use with medical
oxygen from class I to class II, and designating a special control for
these devices and for oxygen conserving devices that incorporate a
built-in oxygen pressure regulator, is necessary to provide reasonable
assurance of the safety and effectiveness of these generic device
types.
FDAMA added a new section 510(m) to the act. 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 the
agency determines that premarket notification is not necessary to
assure the safety and effectiveness of the device. FDA has determined
that premarket notification is not necessary to provide reasonable
assurance of the safety and effectiveness of oxygen pressure regulators
when the manufacturer meets the ASTM standard G175-03 identified in the
special controls guidance.
IV. What Is the Regulatory History of These Devices?
In the Federal Register of July 16, 1982 (47 FR 31130), FDA issued
a final rule classifying oxygen pressure regulators into class II as
part of a generic group of devices known as pressure regulators (21 CFR
868.2700) (the 1982 final rule). The 1982 final rule also classified
noncontinuous ventilators, which includes oxygen conservers, into class
II (21 CFR 868.5905). At that time, under the existing classification
scheme set forth in section 513 of the act, the agency determined that
the establishment of a performance standard was appropriate to provide
reasonable assurance of the safety and effectiveness of these device
types.
Because of a lack of reported adverse events or threats to the
public health associated with the use of oxygen pressure regulators,
however, the agency later determined that general controls by
themselves would provide such assurance. Accordingly, when FDA
published a proposed rule on July 28,
[[Page 8645]]
1995 (60 FR 38902), which proposed to reclassify 112 generic types of
devices from class II to class I, FDA included pressure regulators. FDA
received no comments regarding the proposed reclassification of
pressure regulators and they were reclassified into class I by final
rule on January 16, 1996 (61 FR 1117).
V. What Is the Public Health Concern FDA Is Addressing With This Rule?
Since the January 16, 1996, final rule, FDA has received over 50
adverse event reports associated with the use of pressure regulators
when used with oxygen. The majority of the adverse event reports
involved oxygen pressure regulators that were made from aluminum.
Although the number of events suggests that these occurrences are
infrequent, the severity of each event has been significant, including
at least one reported death attributable to this problem. In one case,
a firefighter suffered third degree burns to the left hand and arm. In
a separate incident, another firefighter suffered severe burns to the
arms, chest, neck, and face. Overall, these reported incidents show
that users of oxygen pressure regulators, including firefighters,
emergency medical staff, healthcare workers, and patients, have
experienced severe and even fatal bodily trauma. A comprehensive list
of reported adverse events may be found by accessing the agency's
Manufacturer and User Facility Device Experience Database (MAUDE) at
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm.
As previously discussed in section II of this document, medical
oxygen is packaged in high pressure cylinders. The oxygen is released
through a part of the cylinder called the post-valve at approximately
2,200 pounds per square inch. The pressure must be reduced, however, to
50 pounds per square inch so that medical oxygen can safely be
delivered to a patient. To reduce the pressure, a regulator is affixed
to the pressurized container of gas and is used to control the gas
flow. Oxygen regulator fires take place when there is a combustible
contaminant (e.g., motor oil, gasoline, hand lotion, cleaning agent) in
the flow channel of the oxygen regulator and when the post valve is
opened very rapidly. In such situations, the oxygen, on being released
from the tank through the post valve, undergoes a rapid expansion and
drop in pressure. Upon entering the constricted channels of the oxygen
regulator, the gas is recompressed, causing a rapid rise in
temperature. If there are combustible contaminants in the flow channels
of the oxygen regulator during this rapid rise in temperature, they can
catch fire in an environment of relatively high pressure oxygen at high
flow rates. The oxygen markedly increases the likelihood and severity
of the fire, resulting in serious risk to patients and healthcare
workers. Minute shavings of aluminum that collect in aluminum oxygen
tanks can also play a role in this process. The shavings can become
trapped in the released gas and create friction sparks as they hit the
oxygen regulator flow channel walls. Such sparking can cause
contaminants to burn in the presence of pressurized oxygen at high
rates of flow.
To address the adverse events described previously in this section
of the document, FDA and the National Institute for Occupational Safety
and Health (NIOSH) issued a public health advisory in February 1999 to
fire departments, safety directors, biomedical engineers, nursing
homes, emergency transportation services, rescue squads, state
emergency medical squad systems, hospital administrators, risk
managers, and home health care agencies (Ref. 1). The advisory warned
of the potential for explosion or fire associated with pressure
regulators when used with medical oxygen. In response to the FDA and
NIOSH advisory, many manufacturers stopped producing aluminum
regulators, others conducted additional testing, and one voluntarily
recalled its products.
VI. How Will More Regulatory Control Reduce the Risks Associated With
Pressure Regulators Used With Medical Oxygen?
While the public health advisory served to make manufacturers and
users aware of the hazards associated with use of oxygen pressure
regulators, it does not address the underlying concerns of safety and
effectiveness. To address these concerns, FDA is proposing to
reclassify these devices into class II, subject to special controls.
Pressure regulators for use with all other medical gases would remain
in class I. The proposed special control is a draft guidance document
entitled ``Class II Special Controls Guidance Document: Oxygen Pressure
Regulators and Oxygen Conserving Devices.'' The guidance contains
labeling recommendations and explains that FDA recognizes ASTM G175-03,
``Standard Test Method for Evaluating the Ignition Sensitivity and
Fault Tolerance of Oxygen Regulators Used for Medical and Emergency
Applications.'' Manufacturers who follow the labeling recommendations
and the testing protocols in the guidance would satisfy the special
control requirements for oxygen pressure regulators. The draft guidance
would also serve as a special control for oxygen conservers that
incorporate a built-in oxygen pressure regulator, devices already
classified into class II. Interested persons can obtain the standard
from ASTM International, 100 Barr Harbor Dr., West Conshohocken, PA
19428-2959. Further information about ASTM is found at http://www.astm.org. (FDA has verified the Web site address, but we are not
responsible for subsequent changes to the Web site after this document
published in the Federal Register.) Elsewhere in this issue of the
Federal Register, FDA is publishing a notice of availability of the
draft special controls guidance document.
Preventing fires associated with the use of oxygen pressure
regulators requires manufacturers to eliminate active ignition
mechanisms in the system or to compensate for their presence.
Eliminating the ignition mechanisms is unrealistic, given the
conditions of use of medical oxygen pressure regulators, especially in
emergency medical service applications where fire and explosion cause
the most catastrophic results. Therefore, to mitigate the risks
associated with the various potential ignition sources, careful
attention to materials selection and established design practice is
critical to ensure the fire safety of oxygen regulators.
FDA believes that manufacturers can best validate fire safety
design through the use of standard test methods. The consensus standard
identified in the special controls guidance describes a two-tier test
method for evaluating the ignition sensitivity and fault tolerance of
oxygen regulators used for medical and emergency applications. The
first test identified by ASTM G175-03 is a rapid pressurization test.
It is equivalent to standard 10524, ``Pressure Regulators and Pressure
Regulators with Flow-Metering Devices for Medical Gas Systems,''
originally developed by the International Organization for
Standardization (ISO) in 1995. The second test is a promoted ignition
test and was developed by ASTM in cooperation with industry, oxygen
safety experts, and FDA.
Overall, the standard is intended to account for all potential
types of ignition mechanisms present under normal conditions and
reasonably foreseeable atypical conditions, including use error.
Adherence to the standard can control the risk of fire and explosion by
ensuring that manufacturers design regulators to have a low probability
of ignition (i.e., greater
[[Page 8646]]
ignition resistance) and a low consequence of ignition. In this way,
the special control can be used as an aid in designing and evaluating
the safety of pressure regulators used with medical oxygen. Designation
of this guidance document as a special control means that these devices
must meet either the specific recommendations of the guidance or some
alternate measure that provides equivalent assurance of safety and
effectiveness.
FDA is proposing that oxygen pressure regulators that meet the ASTM
testing standard identified in the special controls guidance be exempt
from premarket notification requirements, subject to the limitations of
exemption in Sec. 868.9. If the device did not meet the ASTM testing
standard, then the manufacturer would be required to submit a premarket
notification that includes information demonstrating that the alternate
measure used provides equivalent assurance of safety and effectiveness.
Under the proposed rule, manufacturers of oxygen pressure
regulators that meet the ASTM standard would be required to permanently
affix to the body of the regulator a statement indicating that the
device conforms with ASTM G175-03, ``Standard Test Method for
Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen
Regulators Used for Medical and Emergency Applications.'' Similarly,
manufacturers of oxygen conserving devices with a built-in oxygen
pressure regulator that meet the ASTM standard would also be required
to provide labeling that states the oxygen pressure regulator's
conformity with ASTM G175-03. In the case of these devices, however,
manufacturers would be required to affix the statement to the body of
the oxygen conserving device, not the built-in oxygen pressure
regulator.
Unlike oxygen pressure regulators, oxygen conserving devices with a
built-in oxygen pressure regulator that meets the ASTM standard would
not be exempt from premarket notification requirements. This is because
the oxygen pressure regulator is just one component of this device and
FDA has previously determined that the submission of a 510(k) is
necessary to provide reasonable assurance of the safety and
effectiveness of oxygen conserving devices. However, manufacturers of
oxygen conserving devices with a built-in oxygen pressure regulator who
can certify conformance with ASTM G175-03 may be able to submit an
abbreviated 510(k) rather than a traditional one.
VII. What Other Alternatives Were Considered by FDA?
FDA considered other alternatives to address the risks associated
with use of oxygen pressure regulators, but concluded that
reclassifying pressure regulators for use with medical oxygen from
class I to class II and designating a special control for these
devices, and for oxygen conserving devices that incorporate a built-in
oxygen pressure regulator, best addresses the public health and safety
concerns associated with these devices in the most efficient and timely
manner.
A. Public Outreach
One approach FDA considered was a public outreach campaign. Safety
alerts and educational materials, however, would serve only to further
identify the risks to health associated with the use of these devices,
but would not serve as a sufficient mitigation measure against them. As
discussed previously in this document, FDA, in conjunction with NIOSH,
issued a safety advisory alerting industry and consumers of the adverse
event reports received by the agency as well as the risks associated
with the use of oxygen pressure regulators. The safety alert increased
public awareness of the risks to health associated with use of these
devices and prompted some manufacturers to modify their materials
selection. At the same time, FDA continued to receive reports of
adverse events associated with combustion after the safety advisory was
issued and concluded, therefore, that public advisories cannot be a
substitute for safety controls necessary to ensure the public health.
B. A Mandatory Performance Standard
Another approach FDA considered was to establish a mandatory
performance standard. However, a mandatory performance standard may be
less flexible than a special controls guidance document in the face of
changing market conditions and/or technological circumstances. The
proposed rule and special controls guidance document allow for more
flexibility. For example, the manufacturer may choose to meet the
recommendations of the special controls guidance document or choose to
follow some other approach that provides equivalent assurances of
safety and effectiveness.
C. Labeling
FDA also considered both mandatory and voluntary labeling as the
sole means of addressing the risks associated with these devices.
Specifically, FDA considered requiring or suggesting that manufacturers
state whether the device conforms with ASTM G175-03. Neither labeling
alternative, however, would require that the devices meet a standard or
alternate measure providing equivalent assurances of safety and
effectiveness. Thus, FDA concluded that labeling by itself fails to
address the underlying potential risks associated with use of these
devices.
VIII. How Will FDA Implement a Final Rule?
FDA proposes that any final rule that may issue based on this
proposal would become effective 2 years after the date of its
publication in the Federal Register. Such final rule would apply to all
models of oxygen regulators and oxygen conservers with a built-in
oxygen pressure regulator. Thus, beginning 2 years after publication of
a final rule in the Federal Register, all oxygen pressure regulators
would become class II devices and would be required to comply with the
special controls guidance or an alternative measure that provides
equivalent assurances of safety and effectiveness before they could be
legally marketed. Once the final rule takes effect, any oxygen pressure
regulator that does not meet either the special control or an
alternative measure that provides equivalent assurances of safety and
effectiveness will be rendered violative under the act and cannot be
introduced into interstate commerce. FDA is proposing that a final rule
based on this proposal be effective 2 years after the date of its
publication in the Federal Register in order to safeguard against
potential device shortages. Because oxygen pressure regulators are
short-lived devices, this 2-year period will allow manufacturers ample
time to test and introduce compliant oxygen pressure regulator models,
while any existing, non-compliant models are phased-out of the
marketplace.
A. Exemption From Premarket Notification (510(k)) Requirements
Upon the effective date of any final rule that issues from this
proposal, oxygen pressure regulators would generally be exempt from the
premarket notification (510(k)) requirements of the act if they meet
the ASTM standard specified in the special controls guidance and follow
the labeling recommendations set forth in the guidance. However,
manufacturers of oxygen pressure regulators who use measures other than
the ASTM standard identified in the special controls guidance would be
required to submit a premarket notification establishing that the
alternate measures provide
[[Page 8647]]
equivalent assurances of safety and effectiveness.
B. Oxygen Conservers
Oxygen conserving devices will remain class II devices, however,
those oxygen conservers that have a built-in oxygen pressure regulator
will also become subject to the special controls established for the
oxygen pressure regulator. As such, beginning on the 2-year effective
date, oxygen conservers with a built-in oxygen pressure regulator would
become subject to the special controls guidance. Although manufacturers
of oxygen conservers with a built-in oxygen pressure regulator that
meet the special controls guidance would still need to meet premarket
notification requirements, these manufacturers could submit an
abbreviated 510(k).
Again, to safeguard against potential device shortages, FDA is
proposing that any final rule that issues based on this proposal be
effective 2 years after the date of its publication in the Federal
Register. The 510(k) provides reasonable assurances of safety and
effectiveness for these devices.
IX. What Is the Environmental Impact of the Proposed Rule?
The agency has determined under 21 CFR 25.34(b) that this
reclassification 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.
X. What Are the Economic Impacts of This Rule?
FDA has examined the impacts of the proposed 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 proposed 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. The agency certifies that the proposed rule will not
have a significant economic impact on a substantial number of small
entities. Nevertheless, because our projections regarding the number of
small entities affected and the economic impact of the proposed rule on
small entities are uncertain, the analysis presented in this section of
the document, along with this preamble, constitutes the agency's
Initial Regulatory Flexibility Analysis (IRFA).
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, including 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 approximately $122 million, using the most current
(2005) Implicit Price Deflator for the Gross Domestic Product. FDA does
not expect this proposed rule to result in any 1-year expenditure that
would meet or exceed this amount.
FDA has reviewed related Federal rules and has not identified any
rules that duplicate, overlap, or conflict with this proposed rule.
A. Background
FDA is proposing to reclassify pressure regulators for use with
medical oxygen as class II medical devices subject to special controls.
The proposed rule also designates a special control for oxygen
conserving devices that incorporate a built-in oxygen pressure
regulator, which are already in class II. The proposed special control
for both types of devices is an FDA draft guidance document that
contains labeling recommendations and recommends conformance with an
ASTM standard. The agency has received reports of adverse events
associated with these devices that have resulted in serious injuries to
emergency medical services personnel and patients, including second and
third degree burns, and at least one patient death. The majority of
adverse event reports associated with these devices involve oxygen
pressure regulators made from aluminum. As discussed in greater detail
in sections I and II of this document, the agency is proposing these
actions in order to provide reasonable assurance of product safety and
effectiveness.
B. Affected Entities
This proposed rule would affect manufacturers of oxygen pressure
regulators and noncontinuous ventilators (oxygen conservers) that
incorporate a built-in oxygen pressure regulator. FDA is aware of 19
manufacturers and approximately 1.5 million to 2 million affected
devices currently in use in the emergency medical services and home
health care environments. Under this proposed rule, manufacturers of
both new and already marketed devices would be required to demonstrate
that their devices conform with either the labeling recommendations and
the ASTM standard referenced in the guidance document, or some
alternate measure that provides equivalent assurance of safety and
effectiveness. Also, under the proposed rule, if an oxygen pressure
regulator meets the ASTM G175-03 standard, it would be exempt from
premarket notification (or 510(k)) requirements, subject to the
limitations on exemptions described in Sec. 868.9. Oxygen pressure
regulators that do not meet the ASTM G175-03 standard would not be
exempt and manufacturers of these devices would be required to submit a
premarket notification (510(k)) and receive an order of substantial
equivalence from FDA in order to legally market their devices (sections
510(k) and (m) and 513(f) and (i) of the act; see also proposed Sec.
868.2750(b)(1)). Devices that do not meet the ASTM G175-03 standard and
are not found to be substantially equivalent to devices that meet the
standard may be adulterated (section 501(f)(1)(B) of the act (21 U.S.C.
351(f)(1)(b))). Finally, under the proposed rule, devices that meet the
ASTM G175-03 standard would be required to bear a statement that the
device conforms to the standard (proposed Sec. Sec. 868.2750(b)(2) and
868.5910(b)(3)). All elements of any final rule based on this proposed
rule would become effective 2 years after publication in the Federal
Register.
C. Compliance Requirements and Costs
The major compliance burden associated with this proposed rule is
the cost of testing affected devices to demonstrate that they conform
with the ASTM standard or submitting a premarket notification
demonstrating that an alternate measure provides equivalent assurances
of safety and effectiveness. Manufacturers would incur these costs for
existing oxygen pressure regulator models they wish to continue
marketing, as well as for new models of oxygen pressure regulators they
wish to introduce into interstate commerce.
The standard incorporated by reference in Sec. Sec. 868.2750(b)
and 868.5910(b)(3) is ASTM G175-03, ``Standard Test Method for
Evaluating
[[Page 8648]]
the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators used
for Medical and Emergency Applications.'' This two-tier test is
expected to cost between $4,000 and $6,500 for each model of regulator
tested, based on the submission of 5 individual test articles. The
lower figure represents the estimated cost for many predicate devices,
which will not require phase 1 testing because manufacturers have
already met this part of the standard in validating their current
designs.
An internet search for available information indicated that
manufacturers typically produce between 2 and 9 models of these
devices. The average number of models produced by manufacturers for
which data were available was 4.5 devices per manufacturer. Based on
this information, the average one-time cost for testing existing
devices is estimated to range from $18,000 ($4,000 per device x 4.5
devices) to $29,250 ($6,500 per device x 4.5 devices) per manufacturer.
Applying this range of costs to the 19 known manufacturers yields total
one-time testing costs for existing devices that range from $342,000
($18,000 x 19 manufacturers) to $555,750 ($29,250 x 19 manufacturers).
The actual one-time testing burden may be lower than these
estimates suggest because some of these costs have already been
incurred by affected entities. Currently, FDA knows of five
manufacturers that have voluntarily submitted regulators for additional
testing, and three more that plan to do so. However, if either the
number of manufacturers or the number of affected models per
manufacturer is significantly greater than assumed in this analysis,
the one-time testing burden may be greater than FDA's estimates
suggest.
Currently, the agency has no basis for predicting the number or
pattern of introduction of new models of affected devices in the
future. Therefore, FDA is unable to generate an estimate of annual or
recurring testing costs at this time. However, information provided by
manufacturers of affected devices indicates that innovation in this
market is relatively infrequent. Manufacturers typically rely on a few
standard designs that remain on the market for many years with only
occasional, minor design changes. It is also the case that, under this
proposed rule, not all design changes will require manufacturers to
submit devices for additional testing. In particular, additional
testing will not be required when design changes do not affect the high
pressure areas of the regulator, or components in ignition prone areas.
Thus, the agency does not expect that the annual or recurring costs to
test affected devices will be significant.
Based on the information presented previously in this document, the
agency estimates that the total annualized cost (assuming a 7-percent
interest rate over 10 years) to test existing affected devices will
range from about $49,000 to $79,000 per year. A sensitivity analysis
was also performed (assuming a 3-percent interest rate over 10 years)
and suggests a total annualized cost of between $40,000 and $65,000 per
year. These figures should be interpreted as lower-bound estimates of
the true burden because they do not reflect the annual or recurring
costs for manufacturers to test new or redesigned devices. The agency's
cost estimates are summarized in table 1 of this document.
Table 1.--Summary of Cost Estimates\1\
------------------------------------------------------------------------
Total
Total One-Time Cost Total Annual Total Annualized Annualized
Cost Cost\2\ Cost\3\
------------------------------------------------------------------------
$342,000 to Unknown minimal $49,000 to $40,000 to
$556,000 $79,000 $65,000
------------------------------------------------------------------------
\1\ All figures expressed in $US (2005).
\2\ At 7-percent interest over 10 years.
\3\ At 3-percent interest over 10 years.
FDA does not intend to take enforcement action against end users of
devices that fail to meet the special control. Therefore, the proposed
rule is not expected to impose any direct costs on end users of these
devices. However, although not required under this proposed rule, some
manufacturers of affected devices may voluntarily incur costs to recall
or replace marketed devices that do not meet the class II special
control. FDA has been informed that a significant amount of voluntary
recall and replacement has already occurred. Many affected entities,
including the manufacturer of the model most commonly associated with
the adverse events reported to FDA, have ceased production of
regulators made only from aluminum and/or recalled implicated devices.
These voluntary actions on the part of manufacturers were taken in
response to the issuance of the FDA/NIOSH public health advisory in
February 1999, as discussed previously in this document.
Some manufacturers may also incur costs to redesign affected
products in response to the special control. The agency currently has
no basis for predicting the extent of redesign activities in the
future. However, FDA has been informed that 15 affected entities plan
to manufacture at least one model of a ``brass-only'' regulator in the
future, and all 19 manufacturers known to the agency have indicated
that they will no longer produce regulators with aluminum parts in
ignition prone areas. These manufacturers have generally redesigned
existing models to be constructed entirely of brass, or to consist of a
brass core with an aluminum housing. A search for information on the
internet also revealed that only about 10 percent of regulators
available on the market today are made from aluminum. The agency is
also aware that manufacturers and distributors of affected devices are
advertising the availability of brass only regulators designed in
accordance with FDA and NIOSH recommendations. Due to uncertainty
regarding the timing and extent of redesign activity that may occur as
a result of this proposed rule, the agency is not able to quantify this
potential source of compliance costs.
The labeling requirement specified in the proposed rule is not
expected to generate a significant new cost burden for affected
entities because labeling is already required for all medical devices
under 21 CFR part 801. A manufacturer can comply with the requirement
by adding to the body of the device a permanent sticker that states the
device meets ASTM G175-03. Therefore, FDA believes that this
requirement will impose only nominal costs on affected entities.
D. Benefits
The proposed rule is expected to generate benefits due to a
reduction in the number of adverse events associated with oxygen
regulators. Major categories of costs incurred as a result of these
adverse events include: (1) Expenditures for medical treatment of
resulting
[[Page 8649]]
injuries; (2) work, income, and productivity loss; and (3) pain and
suffering.
Pressure regulators for use with medical oxygen were reclassified
as class I medical devices in January 1996, and FDA received 55 reports
of regulators involved with fires and/or explosions between 1993 and
2005. These events resulted in serious injuries to 40 individuals,
consisting mainly of burns, typically second and/or third degree burns
to the hands, arms, chest, neck and/or face, and at least 1 patient
death. These figures imply an average of 4 adverse events (55 adverse
events/13 years = 4.23) and 3 cases of serious injury to individuals
(40 serious injuries/13 years = 3.08) annually.
The U.S. Consumer Product Safety Commission (CPSC) collects
information on various types of consumer product-related injuries and
generates estimates of the associated costs. In a 1998 report (Ref. 2),
the CPSC presents estimates of the: (1) Lifetime medical costs; (2)
total of short-term and long-term victim work-loss; and (3) pain and
suffering cost per survivor of consumer-product related injury, both by
the nature of injury and body part injured. These cost estimates are
further categorized by type of treatment received, e.g., non-hospital
admitted, which typically includes treatment in a physician's office or
emergency department, and hospital admitted, or inpatient care. The
CPSC estimates are based on the Revised Injury Cost Model and are
designed to be representative of the costs of treating consumer product
related injuries on average, adjusting for various demographic and
other factors. The figures in the CPSC report are expressed in 1995
dollars, and were adjusted to 2005 dollars based on inflation
statistics reported by the U.S. Department of Labor. The CPSC cost
estimates used in this analysis are summarized in table 2 of this
document.
Table 2.--Costs of Treating Burn Injuries by the National Electronic
Injury Surveillance System (NEISS) Injury Diagnosis Code and Type of
Treatment (per occurrence)\1\
------------------------------------------------------------------------
NEISS Injury Treatment Pain and
Diagnosis Code Costs Income Loss Suffering Total Costs
------------------------------------------------------------------------
a. Non-Hospitalized--Emergency Department Treatment
------------------------------------------------------------------------
51: Burns, thermal $750 $1,700 $24,700 $27,150
------------------------------------------------------------------------
84: 25% to 50% of $1000 $1,000 $8,300 $10,300
body
------------------------------------------------------------------------
b. Admitted/Inhospital Treatment
------------------------------------------------------------------------
51: Burns, thermal $39,300 $36,800 $177,200 $253,300
------------------------------------------------------------------------
84: 25% to 50% of $49,400 $54,400 $190,600 $294,400
body
------------------------------------------------------------------------
\1\ All figures expressed in $US (2005).
The NEISS diagnosis codes reflected in tables 2a and 2b of this
document were chosen for this analysis because they are the most
relevant given the type of injuries typically cited in the adverse
event reports. The lower figures in table 2a of this document are
indicative of the costs of treating relatively minor burn injuries
associated with the less serious oxygen pressure regulator adverse
events. The higher figures in table 2b of this document reflect the
costs of treating severe injuries associated with the more serious
adverse events. The majority of adverse events reported to the agency
appear to fall into the latter, more serious, category.
Based on the cost estimates obtained from the CPSC report and using
the average number of reported adverse events (4), a range of annual
benefits estimates (reflecting medical treatment costs, work/income
loss and pain and suffering avoided) can be generated. The estimated
annual benefits associated with this proposed rule are presented in
table 3 of this document.
Table 3.--Summary of Total Annual Benefits Estimates\1\
----------------------------------------------------------------------------------------------------------------
NEISS Injury Diagnosis Code Emergency Department Treatment Admitted/Inhospital Treatment
----------------------------------------------------------------------------------------------------------------
51: Burns, thermal $109,000 $1 million
----------------------------------------------------------------------------------------------------------------
84: 25% to 50% of body $41,000 $1.2 million
----------------------------------------------------------------------------------------------------------------
\1\ All figures expressed in $US (2005).
Based on this information, the estimated annual benefits of this
proposed rule are expected to be between $41,000 and $1.2 million.
These figures should be interpreted as conservative, lower bound
estimates of the potential benefits of this proposed rule for a number
of reasons. First, the adverse event reports upon which these estimates
are based were submitted voluntarily, and the agency is aware that many
adverse events are not reported under the current voluntary systems. A
1997 General Accounting Office report (Ref. 3) on FDA's reporting
systems found evidence of significant under-reporting of adverse events
associated with medical devices. Thus, the risks associated with
affected devices, as well as the potential benefits of the proposed
rule, may be significantly greater than the agency's estimates suggest.
Second, because of a lack of data, no attempt was made to estimate the
value of property damage associated with the adverse events reported.
In one case, cited in section V of this document, the interior
compartment of an ambulance was incinerated as a result of an oxygen
pressure regulator fire/explosion, resulting in a loss of valuable
property. Finally, the estimates presented in table 3 of this document
do not reflect the potential benefits of any reduction in mortality
risk resulting from oxygen pressure regulator fires and/or
[[Page 8650]]
explosions. Voluntary reports of adverse events submitted to the agency
indicate that at least one death was associated with oxygen pressure
regulator fires and/or explosions during the period 1993 to 2005. The
agency expects that this proposed rule would significantly reduce the
risk of similar events in the future.
If, however, recent actions on the part of manufacturers (since
issuance of the 1999 public health advisory) have already reduced the
risk of oxygen regulator fires and explosions, FDA's estimates may
overstate the potential benefits of this proposed rule to some extent.
E. Impact on Small Entities
FDA believes that it is unlikely that the proposed rule would have
a significant economic impact on a substantial number of small
entities. The agency knows of 19 firms currently manufacturing the
affected devices. Some of the entities affected by this proposed rule
meet the Small Business Administration's (SBA) criteria characterizing
small entities in the relevant industry category. The North American
Industry Classification System (NAICS) code for manufacturers of oxygen
pressure regulators is 339112--Surgical and Medical Instrument
Manufacturing. According to the SBA criteria, a small firm in this
industry sector has fewer than 500 employees (Ref. 4.) A review of
available data, including the internet sites of Dun and Bradstreet[reg]
(http://www.dnb.com) and ThomasRegister[reg] (http://www.thomasnet.com)
(Refs. 5 and 6), revealed that 12 manufacturers of these devices had
fewer than 500 employees and would therefore be considered small
entities. (FDA has verified the Web site addresses, but we are not
responsible for subsequent changes to the Web sites after this document
publishes in the Federal Register. Thus, a majority, or approximately
63 percent [(12 / 19) x 100], of entities affected by this proposed
rule would qualify as small entities.
An FDA review of available data found that the average annual
revenue of small entities affected by this rule is approximately $123
million (Refs. 5 and 6). The total annualized cost for this proposed
rule (assuming a 7-percent interest rate) ranges from $49,000 to
$79,000, and an average annualized cost per affected entity ranging
from $2,600 ($49,000 / 19 entities) to $4,200 ($79,000 / 19 entities).
A sensitivity analysis was also performed (assuming a 3-percent
interest rate) and suggests a total annualized cost of between $40,000
and $65,000. These estimates correspond to an average annualized cost
of between $2,100 and $3,400 per affected entity. Thus, the average
annualized cost of the proposed rule, expressed as a percentage of
average annual revenues for affected small entities, ranges from 0.002
[ ($2,100 / $123 million) x 100 = 0.0017 ] percent to 0.003 [ ($4,200 /
$123 million) x 100 = 0.0034 ] percent. This information is summarized
in table 4 of this document.
Table 4.--Summary of Small Business Impacts\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average Annualized Cost as a
Interest Rate Total Annualized Cost Average Annualized Cost Percentage of Average Revenue
--------------------------------------------------------------------------------------------------------------------------------------------------------
7% $49,000 to $79,000 $2,600 to $4,200 0.002% to 0.003%
--------------------------------------------------------------------------------------------------------------------------------------------------------
3% $40,000 to $65,000 $2,100 to $3,400 0.002% to 0.003%
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ All figures expressed in $US (2005).
As discussed earlier in this section of the document, the economic
impacts of the proposed rule are not expected to be significant.
Therefore, the agency believes that the rule will not have a
significant economic impact on a substantial number of small entities.
However, due to uncertainty with respect to the size distribution of
manufacturers, the number of affected devices that will be introduced
in the future, and the overall impact of the rule on small entities,
the agency is unable to certify that there would be no significant
economic impact on a substantial number of small entities. Therefore,
FDA specifically requests detailed industry comment on the number of
affected small entities and the potential economic impact of the
proposed rule on affected entities.
A number of provisions of the proposed rule would help to minimize
the economic impact of the rule, particularly for affected small
entities. For example, affected devices would not be required to comply
with the special control until 2 years after publication of any final
rule based on this proposal. This time period would allow manufacturers
an opportunity to make any necessary design changes, test products, and
modify labeling. In addition, this should help prevent product
shortages and thereby minimize the potential for significant
fluctuation in the price of the affected devices.
In addition, manufacturers who choose not to meet the ASTM G175-03
standard referenced in the special control would have the option to
demonstrate, through the pre-market notification (510(k)) process, that
their devices are substantially equivalent to devices that meet the
standard. This provides manufacturers of the affected devices with more
flexibility in complying with the special controls necessary to provide
reasonable assurances of the safety and effectiveness of these devices.
FDA has considered several regulatory alternatives to this proposed
rule in addition to taking no regulatory action at all. The
alternatives are: (1) Public outreach, (2) adoption of a mandatory
performance standard, and (3) product labeling alone. Taking no action
was deemed inappropriate because the adverse event reports received by
the agency indicate that these devices present a clear risk to public
health and safety. Similarly, although public outreach through the FDA/
NIOSH safety advisory alerted consumers to the risks to health
associated with the use of oxygen pressure regulators, it did not
provide a sufficient means for mitigating those risks.
A mandatory performance standard was rejected in favor of the
special control guidance document for several reasons. A mandatory
performance standard may be less flexible than a special controls
guidance document in the face of changing market conditions and
technological circumstances. The special controls guidance document
allows for some flexibility. For example, the manufacturer may meet
either the recommendations of the special controls guidance document or
some other measure that provides equivalent assurances of safety and
effectiveness. FDA believes that the proposed rule will address the
risks to health presented by
[[Page 8651]]
these devices without significantly disrupting the market for these
devices.
FDA also considered both mandatory and voluntary labeling alone as
the special control. We rejected these options because labeling
provisions alone, whether mandatory or voluntary, would not ensure that
the devices meet some accepted industry standard or other equivalent
measure and, therefore, would not provide adequate assurances of
product safety and effectiveness. Furthermore, a voluntary labeling
provision would leave the agency without an effective monitoring and
enforcement mechanism. FDA believes that reclassifying pressure
regulators for use with medical oxygen from class I to class II and
designating a special control for these devices, and for oxygen
conserving devices that incorporate a built-in oxygen regulator, best
addresses the public health and safety concerns associated with these
devices in the most efficient and timely manner.
XI. Are There Any Paperwork Burdens Created by the Proposed Rule Under
the Paperwork Reduction Act of 1995?
No. The labeling statements that would be required by this
regulation are ``public disclosure[s] of information originally
supplied by the Federal government to the recipient for the purpose of
disclosure to the public * * *'' (5 CFR 1320.3(c)(2)). Accordingly, FDA
concludes that the labeling requirements in this proposed rule are not
subject to review by the Office of Management and Budget under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
XII. What if I Have Comments to the Proposed Rule?
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
XIII. What Are the References for the Proposed Rule?
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
1. FDA and NIOSH Public Health Advisory: Explosions and Fires in
Aluminum Oxygen Regulators, February 1999.
2. U.S. Consumer Product Safety Commission, Estimating the Cost
to Society of Consumer Product Injuries: The Revised Injury Cost
Model, January 1998.
3. U.S. General Accounting Office, Medical Device Reporting:
Improvements Needed in FDA's System for Monitoring Problems with
Approved Devices, January 1997.
4. U.S. Small Business Administration, Office of Size Standards,
Table of Size Standards, Sector 62--Health Care and Social
Assistance, 2002.
5. Dun and Bradstreet[reg], available online at http://www.dnb.com.
6. Thomas Register[reg], available online at http://www.thomasnet.com.
List of Subjects in 21 CFR Part 868
Incorporation by reference, Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 868 be amended as follows:
PART 868--ANESTHESIOLOGY DEVICES
1. The authority citation for 21 CFR part 868 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
2. Section 868.2700 is amended by revising paragraph (a) to read as
follows:
Sec. 868.2700 Pressure regulator.
(a) Identification. A pressure regulator is a device, often called
a pressure-reducing valve, that is intended for medical purposes and
that is used to convert a medical gas pressure from a high variable
pressure to a lower, more constant working pressure. This device does
not include pressure regulators for use with medical oxygen.
* * * * *
3. Section 868.2750 is added to supbart C to read as follows:
Sec. 868.2750 Oxygen pressure regulator.
(a) Identification. An oxygen pressure regulator is a device, often
called a pressure-reducing valve, that is intended for medical purposes
and that is used to convert medical oxygen pressure from a high
variable pressure to a lower, more constant working pressure.
(b) Classification. (1) Class II (special controls). The special
control for this device is FDA's ``Class II Special Controls Guidance
Document: Oxygen Pressure Regulators and Oxygen Conserving Devices.''
See Sec. 868.1(e) for the availability of this guidance document. If
the device meets American Society for Testing and Materials Standard
(ASTM) G175-03, ``Standard Test Method for Evaluating the Ignition
Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical
and Emergency Applications,'' the device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter,
subject to the limitations in Sec. 868.9. ASTM G175-03, ``Standard
Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance
of Oxygen Regulators Used for Medical and Emergency Applications'' is
incorporated by reference.
(2) If the device conforms with American Society for Testing and
Materials Standard (ASTM) G175-03, ``Standard Test Method for
Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen
Regulators Used for Medical and Emergency Applications,'' the device
must bear a statement permanently affixed to the body of the regulator
that states: ``Conforms with ASTM G175-03.'' ASTM G175-03, ``Standard
Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance
of Oxygen Regulators Used for Medical and Emergency Applications'' is
incorporated by reference.
4. Section 868.5905 is amended by revising paragraph (a) to read as
follows:
Sec. 868.5905 Noncontinuous ventilator.
(a) Identification. A noncontinuous ventilator is a device intended
to deliver intermittently an aerosol to a patient's lungs or to assist
a patient's breathing. This classification includes intermittent
positive pressure breathing devices, continuous positive airway
pressure devices, and bilevel positive airway pressure devices.
* * * * *
5. Section 868.5910 is added to subpart F to read as follows:
Sec. 868.5910 Oxygen conserver.
(a) Oxygen conserver--(1) Identification. An oxygen conserver is a
device intended to conserve oxygen delivered to a patient, but does not
incorporate a built-in oxygen pressure regulator.
(2) Classification. Class II (performance standards).
(b) Oxygen conserver with built-in oxygen pressure regulator--(1)
Identification. An oxygen conserver with built-in oxygen pressure
regulator is a device intended to conserve oxygen delivered to a
patient and incorporates a built-in oxygen pressure regulator.
(2) Classification. Class II (special controls). The special
control for an oxygen conserver with built-in oxygen
[[Page 8652]]
pressure regulator is FDA's ``Class II Special Controls Guidance
Document: Oxygen Pressure Regulators and Oxygen Conserving Devices.''
See Sec. 868.1(e) for the availability of this guidance document.
(3) If the built-in oxygen pressure regulator conforms with ASTM
G175-03, ``Standard Test Method for Evaluating the Ignition Sensitivity
and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency
Applications,'' then a statement must be permanently affixed to the
body of the oxygen conserver that states: ``Built-in oxygen pressure
regulator conforms with ASTM G175-03.'' ASTM G175-03, ``Standard Test
Method for Evaluating the Ignition Sensitivity and Fault Tolerance of
Oxygen Regulators Used for Medical and Emergency Applications'' is
incorporated by reference.
Dated: February 8, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-3253 Filed 2-26-07; 8:45 am]
BILLING CODE 4160-01-S