[Federal Register: February 27, 2007 (Volume 72, Number 38)]
[Proposed Rules]               
[Page 8643-8652]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27fe07-20]                         

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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controls draft guidance for industry and FDA staff entitled ``Class II 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov. 

Follow the instructions for submitting comments.
     Agency Web site: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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: //http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.dnb.com) and ThomasRegister[reg] (http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.dnb.com
.

    6. Thomas Register[reg], available online at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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