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Medical Devices; General and Plastic Surgery Devices; Classification of the Low Energy Ultrasound Wound Cleaner
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[Federal Register: November 7, 2005 (Volume 70, Number 214)]
[Rules and Regulations]
[Page 67353-67355]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07no05-9]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 878
[Docket No. 2005P-0366]
Medical Devices; General and Plastic Surgery Devices;
Classification of the Low Energy Ultrasound Wound Cleaner
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is classifying the low
energy ultrasound wound cleaner into class II (special controls). The
special control that will apply to the device is the guidance document
entitled ``Class II Special Controls Guidance Document: Low Energy
Ultrasound Wound Cleaner.'' The agency is taking this action in
response to a petition submitted under the Federal Food, Drug, and
Cosmetic Act (the act) as amended by the Medical Device Amendments of
1976, the Safe Medical Devices Act of 1990, and the Food and Drug
Administration Modernization Act of 1997 (FDAMA). The agency is
classifying this device into class II (special controls) in order to
provide a reasonable assurance of safety and effectiveness of the
device. Elsewhere in this issue of the Federal Register, FDA is
announcing the availability of the guidance document that will serve as
the special control for the class II device.
DATES: This rule is effective December 7, 2005. The reclassification
was effective June 25, 2004.
FOR FURTHER INFORMATION CONTACT: David B. Berkowitz, Center for Devices
and Radiological Health (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-3090, ext. 152.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with section 513(f)(1) of the act (21 U.S.C.
360c(f)(1)), devices that were not in commercial distribution before
May 28, 1976, the date of enactment of the Medical Device Amendments of
1976 (the amendments), generally referred to as postamendments devices,
are classified automatically by statute into class III without any FDA
rulemaking process. These devices remain in class III and require
premarket approval, unless and until the device is classified or
reclassified
[[Page 67354]]
into class I or II, or FDA issues an order finding the device to be
substantially equivalent, in accordance with section 513(i) of the act,
to a predicate device that does not require premarket approval. The
agency determines whether new devices are substantially equivalent to
previously marketed devices by means of premarket notification
procedures in section 510(k) of the act (21 U.S.C. 360(k)) and 21 CFR
part 807 of FDA's regulations.
Section 513(f)(2) of the act provides that any person who submits a
premarket notification under section 510(k) of the act for a device
that has not previously been classified may, within 30 days after
receiving an order classifying the device in class III under section
513(f)(1) of the act, request FDA to classify the device under the
criteria set forth in section 513(a)(1) of the act. FDA shall, within
60 days of receiving such a request, classify the device by written
order. This classification shall be the initial classification of the
device. Within 30 days after the issuance of an order classifying the
device, FDA must publish a notice in the Federal Register announcing
such classification.
In accordance with section 513(f)(1) of the act, FDA issued an
order on April 8, 2004, classifying the Celleration MIST Therapy
System\TM\ in class III, because it was not substantially equivalent to
a device that was introduced or delivered for introduction into
interstate commerce for commercial distribution before May 28, 1976, or
a device that was subsequently reclassified into class I or class II.
On April 29, 2004, Celleration, Inc., submitted a petition requesting
classification of the Celleration MIST Therapy System\TM\ under section
513(f)(2) of the act. The manufacturer recommended that the device be
classified into class II.
In accordance with 513(f)(2) of the act, FDA reviewed the petition
in order to classify the device under the criteria for classification
set forth in 513(a)(1) of the act. Devices are to be classified into
class II if general controls, by themselves, are insufficient to
provide reasonable assurance of safety and effectiveness, but there is
sufficient information to establish special controls to provide
reasonable assurance of the safety and effectiveness of the device for
its intended use. After review of the information submitted in the
petition, FDA has determined that the low energy ultrasound wound
cleaner intended for the cleaning and maintenance debridement of wounds
can be classified in class II with the establishment of special
controls. FDA believes that class II special controls provide
reasonable assurance of the safety and effectiveness of the device.
The device is assigned the generic name ``Low energy ultrasound
wound cleaner,'' and it is identified as a device that uses ultrasound
energy to vaporize a solution and generate a mist that is used for the
cleaning and maintenance debridement of wounds. Low levels of
ultrasound energy may be carried to the wound by the saline mist.
The potential risks to health associated with the device are:
Delayed wound healing, thermal damage, inflammation/foreign body
response, infection, and electrical shock. The special control guidance
document entitled ``Class II Special Controls Guidance Document: Low
Energy Ultrasound Wound Cleaner'' aids in mitigating the risk by
recommending performance characteristics, safety testing, and
appropriate labeling.
Thus, in addition to the general controls of the act, a low energy
ultrasound wound cleaner is subject to the special controls guidance
document. FDA believes that following the class II special controls
guidance document generally addresses the risks to health identified in
the previous paragraph of this document. Therefore, on June 25, 2004,
FDA issued an order to the petitioner classifying the device as
described previously into class II and is codifying this device by
adding Sec. 878.4410.
Following the effective date of this final rule classifying the
device, any firm submitting a 510(k) premarket notification for the
device will need to address the issues covered in the special controls
guidance. However, the firm would need to show only that its device
meets the recommendations of the guidance, or in some other way
provides equivalent assurances of safety and effectiveness.
Section 510(m) of the act provides that FDA may exempt a class II
device from the premarket notification requirements under section
510(k) of the act, if FDA determines that premarket notification is not
necessary to provide reasonable assurance of the safety and
effectiveness of the device. FDA has determined that premarket
notification is necessary to provide reasonable assurance of the safety
and effectiveness of this type of device and, therefore, the type of
device is not exempt from premarket notification requirements. Thus,
persons who intend to market this type of device must submit to FDA a
premarket notification, prior to marketing the device, which contains
information about the low energy ultrasound wound cleaner that they
intend to market.
II. Environmental Impact
The agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
III. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the
Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 directs agencies to assess all costs and benefits of
available regulatory alternatives and, when regulation is necessary, to
select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this final rule is not a significant regulatory action under the
Executive order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because reclassification of these devices from class
III to class II will relieve manufacturers of the device of the cost of
complying with the premarket approval requirements of section 515 of
the act (21 U.S.C. 360e), and may permit small potential competitors to
enter the marketplace by lowering their costs, the agency certifies
that the final rule will not have a significant economic impact on a
substantial number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $115 million, using the most current (2003) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.
IV. Federalism
FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has
[[Page 67355]]
determined that the rule does not contain policies that have
substantial direct effects on the States, on the relationship between
the National Government and the States, or on the distribution of power
and responsibilities among the various levels of government.
Accordingly, the agency has concluded that the rule does not contain
policies that have federalism implications as defined in the Executive
order and, consequently, a federalism summary impact statement is not
required.
V. Paperwork Reduction Act of 1995
FDA concludes that this rule contains no collections of
information. Therefore, clearance by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44
U.S.C. 3501-3520) is not required.
FDA also concludes that the special controls guidance document does
not contain new information collection provisions that are subject to
review and clearance by OMB under the PRA. Elsewhere in this issue of
the Federal Register, FDA is publishing a notice announcing the
availability of the guidance document entitled ``Class II Special
Controls Guidance Document: Low Energy Ultrasound Wound Cleaner.''
List of Subjects in 21 CFR Part 878
Medical devices.
? Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
878 is amended as follows:
PART 878--GENERAL AND PLASTIC SURGERY DEVICES
? 1. The authority citation for 21 CFR part 878 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
? 2. Section 878.4410 is added to subpart E to read as follows:
Sec. 878.4410 Low energy ultrasound wound cleaner.
(a) Identification. A low energy ultrasound wound cleaner is a
device that uses ultrasound energy to vaporize a solution and generate
a mist that is used for the cleaning and maintenance debridement of
wounds. Low levels of ultrasound energy may be carried to the wound by
the saline mist.
(b) Classification. Class II (special controls). The special
control is FDA's guidance document entitled ``Class II Special Controls
Guidance Document: Low Energy Ultrasound Wound Cleaner.'' See Sec.
878.1(e) for the availability of this guidance document.
Dated: September 28, 2005.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 05-22068 Filed 11-4-05; 8:45 am]
BILLING CODE 4160-01-S