[Federal Register Volume 63, Number 31 (Tuesday, February 17, 1998)]
[Rules and Regulations]
[Pages 7703-7705]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-3776]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 878
[Docket No. 88P-0439]
Medical Devices; Reclassification and Codification of Suction
Lipoplasty System for Aesthetic Body Contouring
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that it
has issued an order in the form of a letter to the American Society for
Aesthetic Plastic Surgery (ASAPS) reclassifying the suction lipoplasty
system for use in aesthetic body contouring from class III (premarket
approval) to class II (special controls). The reclassification is based
on information regarding the device contained in a reclassification
petition submitted by ASAPS and other publicly available information.
Accordingly, the order is being codified in the Code of Federal
Regulations. This action is taken under the Medical Device Amendments
of 1976 (the 1976 amendments) as amended by the Safe Medical Devices
Act of 190 (the SMDA).
DATES: This regulation becomes effective March 19, 1998. The
reclassification order was approved January 5, 1998
FOR FURTHER INFORMATION CONTACT: Stephen P. Rhodes, Center for Devices
and Radiological Health (HFZ09410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-3090.
SUPPLEMENTARY INFORMATION:
I. Background
The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301
et seq.), as amended by the Medical Device Amendments of 1976 (the 1976
amendments) (Pub. L. 9409295) and the Safe Medical Devices Act of 1990
(the SMDA) (Pub. L. 10109629), established a comprehensive system for
the regulation of medical devices intended for human use. Section 513
of the act (21 U.S.C. 360c) established three categories (classes) of
devices, depending on the regulatory controls needed to provide
reasonable assurance of their safety and effectiveness. The three
categories of devices are: Class I (general controls), class II
(special controls), and class III (premarket approval).
Under the 1976 amendments, class II devices were defined as those
devices for which there is insufficient information to show that
general controls themselves will assure safety and effectiveness, but
for which there is sufficient information to establish performance
standards to provide such assurance. The SMDA broadened the definition
of class II devices to mean those devices for which there is
insufficient information to show that general controls themselves will
assure safety and effectiveness, but for which there is sufficient
information to establish special controls to provide such assurance,
including performance standards, postmarket surveillance, patient
registries, development and dissemination of guidelines,
recommendations, and any other appropriate actions the agency deems
necessary under section 513(a)(1)(B) of the act.
It is the agency's position that it is not necessary to obtain a
new reclassification recommendation from a panel which had recommended
reclassification into class II prior to the SMDA. If a panel
recommended that a device be reclassified from class III into class II
under the 1976 definition of class II, which included only performance
standards as a class II control, clearly the Panel's recommendation for
class II status would not change if controls, in addition to
performance standards, could be added.
Under section 513 of the act, devices that were in commercial
distribution before May 28, 1976 (the date of enactment of the 1976
amendments), generally referred to as preamendments devices, are
classified after FDA has: (1) Received a recommendation from a device
classification panel (an FDA advisory committee); (2) published the
panel's recommendation for comment, along with a proposed regulation
classifying the device; and (3) published a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
Devices that were not in commercial distribution prior to May 28,
1976, generally referred to as postamendments devices, are classified
automatically by statute (section 513(f) of the act) into class III
without any FDA rulemaking process. Those devices remain in class III
and require premarket approval, unless and until the device is
reclassified into class I or II or FDA issues an order finding the
device to be substantially equivalent, under 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 offered devices by means of premarket notification
procedures under section 510(k) of the act (21 U.S.C. 360(k)) and part
807 (21 CFR part 807).
A preamendments device that has been classified into class III may
be marketed, by means of premarket notification procedures, without
submission of a premarket approval application (PMA) until FDA issues a
final regulation under section 515(b) of the act (21 U.S.C. 360e(b))
requiring premarket approval.
Section 513(f)(2) of the act provides that FDA may initiate the
reclassification of a device classified into class III under section
513(f)(1) of the act, or the manufacturer or importer of a device may
petition the Secretary of the Department of Health and Human Services
(the Secretary) to reclassify the device into class I or class II.
FDA's regulations in 1A860.134 (21 CFR 860.134) set forth the
procedures for the filing and review of a petition for reclassification
of such class III devices. In order to change the classification of the
device, it is necessary that the proposed new class have sufficient
regulatory controls to provide reasonable assurance of the safety and
effectiveness of the device for its intended use.
Under section 513(f)(2)(B)(i) of the act, the Secretary may, for
good cause shown, refer a petition to a device classification panel. If
a petition is referred to a panel, the panel shall make a
recommendation to the Secretary respecting approval or denial of the
petition. Any such recommendation shall contain: (1) a summary of the
reasons for the recommendation, (2) a summary of the data upon which
the recommendation is based, and (3) an identification of the risks to
health (if any) presented by the device with respect to which petition
was filed.
II. Recommendation of the Panel
On December 28, 1988, FDA filed the reclassification petition
submitted by ASAPS that requested reclassification of the suction
lipoplasty system from class III into class II. FDA consulted with the
General and Plastic Surgery Devices Advisory Panel (the Panel) of the
[[Page 7704]]
Medical Devices Advisory Committee during an open public meeting on
January 26, 1989, and in a telephone conference on March 10, 1989. The
Panel recommended that FDA reclassify the suction lipoplasty system
intended for aesthetic body contouring from class III into class II.
The Panel also recommended that FDA assign a high priority for the
development of a performance standard for the generic type of device.
Subsequently, in the Federal Register of November 13, 1996 (61 FR
58195), FDA issued the Panel's recommendation for public comment.
FDA considered the Panel's recommendation and tentatively agreed
that the generic type of device, suction lipoplasty system intended for
aesthetic body contouring, should be reclassified from class III into
class II. FDA did not, however, agree with the Panel's recommendation
that FDA assign a high priority for the development of a performance
standard. Instead, FDA identified the following voluntary standards as
special controls in lieu of a performance standard: (1) International
Organization for Standardization (ISO) 10079091, Medical Suction
Equipment, Part 1, Electrically Powered Suction Equipment--Safety
Requirements, 1993; (2) Canadian Standards Association (CSA), Standard
Z168.110994, Vacuum Devices Used for Suction and Drainage, 1994; and
(3) International Standard ISO0910993 Biological Evaluation of Medical
Devices Part I Evaluation and Testing, 1995.
Initially, FDA identified the voluntary standard entitled
``Clinical Practice Guidelines, Plastic and Maxillofacial Surgery,
American Society of Plastic and Reconstructive Surgeons, Chapter L:
Localized Adiposity,'' September 1993, as a special control. Upon
further review, however, FDA determined that this voluntary standard
represents a clinical guideline which may vary, and thus is not
appropriate for use as a special control.
FDA believes that the three voluntary standards identified in the
previous paragraph, in addition to special labeling, will provide
reasonable assurance of safety and effectiveness for the device.
FDA identified the following potential risks to health associated
with the device: (1) Airborne bacterial or viral contamination of other
patients and hospital personnel resulting from inefficient or overused
in-line filters, (2) patient bio-incompatibility to the device
materials, and (3) patient infection resulting from improper
sterilization of the device or unsterile techniques.
After reviewing the data and information submitted in the petition
and presented before the Panel, and after considering the Panel's
recommendation and the comments received, FDA, based on the information
set forth, issued an order to the petitioner on January 5, 1998,
reclassifying the suction lipoplasty system intended for aesthetic body
contouring, and substantially equivalent devices of this generic type,
from class III into class II with the implementation of special
controls.
The special controls are in compliance with consensus standards
and labeling restrictions. The following are the consensus standards to
which compliance may be assured:
1. International Organization for Standardization (ISO) 10079091,
Medical Suction Equipment, Part 1, Electrically Powered Suction
Equipment-Safety Requirements, 1993;
2. Canadian Standards Association (CSA), Standard Z168.110994,
Vacuum Devices Used for Suction and Drainage, 1994; and
3. International Standard ISO0910993, Biological Evaluation of
Medical Devices, Part I Evaluation and Testing, 1995.
The specific required labeling consists of the following
statements in the Warnings and Precautions sections of the labeling:
Warnings Section
1. This device will not, in and of itself, produce significant
weight reduction.
2. This device should be used with extreme caution in patients with
chronic medical conditions, such as diabetes; heart, lung, or
circulatory system disease; or obesity.
3. The volume of blood loss and endogenous body fluid loss may
adversely affect intra and/or postoperative hemodynamic stability and
patient safety. The capability of providing adequate, timely
replacement is essential for patient safety.
Precautions Section
1. This device is designed to contour the body by removing
localized deposits of excess fat through small incisions.
2. Use of this device is limited to those physicians who, by means
of formal professional training or sanctioned continuing medical
education (including supervised operative experience), have attained
proficiency in suction lipoplasty.
3. Results of this procedure will vary depending upon patient age,
surgical site, and experience of the physician.
4. Results of this procedure may or may not be permanent.
5. The amount of fat removed should be limited to that necessary to
achieve a desired cosmetic effect.
6. All reusable components of the device must be sterilized and all
disposable components replaced before using the device system on
another patient.
Accordingly, as required by 1A860.134(b)(6) and (b)(7), FDA is
announcing the reclassification of the generic type of device suction
lipoplasty system from class III into class II. In addition, FDA is
issuing the notice to codify the reclassification of the device by
adding new 1A878.5040.
III. Environmental Impact
The agency has determined under 21 CFR 25.34(b) that this
reclassification 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.
IV. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12886 and the Regulatory Flexibility Act (Pub. L. 9609354) (as
amended by subtitle D of the Small Business Regulatory Fairness Act of
1996 (Pub. L. 10409121), and the Unfunded Mandates Reform Act of 1995
(Pub. L. 104094)). Executive Order 12886 directs agencies to access 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 consistent with
the regulatory philosophy and principles identified in the Executive
Order. In addition, the final rule is not a significant regulatory
action as defined by the Executive Order and so is not subject to
review 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. Reclassification of this device from class III into
class II will relieve manufacturers of the cost of complying with the
premarket approval requirements in section 515 of the act. Because
reclassification will reduce regulatory costs with respect to this
device, it will impose no significant economic impact on any small
entities, and it may permit small potential
[[Page 7705]]
competitors to enter the marketplace by lowering their costs. The
Commissioner, therefore, certifies that this final rule will not have a
significant economic impact on a substantial number of small entities.
In addition, this final rule will not impose costs of $100 million or
more on either the private sector or State, local, and tribal
governments in the aggregate, and therefore, a summary statement or
analysis under section 202(a) of the Unfunded Mandates Reform Act of
1995 is not required.
V. Paperwork Reduction Act of 1995
FDA concludes that the labeling requirements in this final rule
are not subject to review by the Office of Management and Budget
because they do not constitute a ``collection of information'' under
the Paperwork Reduction Act of 1995 (Pub. L. 1040913). Rather, the
labeling statements are ``public disclosure 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)).
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 878.5040 is added to subpart E to read as follows:
Sec. 878.5040 Suction lipoplasty system.
(a) Identification. A suction lipoplasty system is a device
intended for aesthetic body contouring. The device consists of a
powered suction pump (containing a microbial filter on the exhaust and
a microbial in-line filter in the connecting tubing between the
collection bottle and the safety trap), collection bottle, cannula, and
connecting tube. The microbial filters, tubing, collection bottle, and
cannula must be capable of being changed between patients. The powered
suction pump has a motor with a minimum of 1/3 horsepower, a variable
vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to
regulate the vacuum with accompanying vacuum gauges, a single or double
rotary vane (with or without oil), a single or double diaphragm, a
single or double piston, and a safety trap.
(b) Classification. Class II (special controls). Consensus
standards and labeling restrictions.
Dated: February 5, 1998.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 98-3776 Filed 2-13-98; 8:45 am]
BILLING CODE 4160-01-F