[Federal Register Volume 61, Number 220 (Wednesday, November 13, 1996)]
[Notices]
[Pages 58195-58199]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-29066]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 88P-0439]


Medical Devices; Reclassification of Suction Lipoplasty System 
for Aesthetic Body Contouring

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of panel recommendation.

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SUMMARY: The Food and Drug Administration (FDA) is issuing for public 
comment the recommendation of the General and Plastic Surgery Devices 
Panel (the Panel) to reclassify the suction lipoplasty system for 
aesthetic body contouring from class III to class II. The Panel made 
this recommendation after reviewing the reclassification petition 
submitted by the American Society for Aesthetic Plastic Surgery (ASAPS) 
and other publicly available information. FDA is also issuing for 
public comment its tentative findings on the Panel's recommendation. 
After considering any public comments on the Panel's recommendation and 
FDA's tentative findings, FDA will approve or deny the reclassification 
petition by order in the form of a letter to the petitioner. FDA's 
decision on the reclassification petition will be announced in the 
Federal Register.

DATES: Written comments by February 11, 1997.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Stephen P. Rhodes, Center for Devices 
and Radiological Health (HFA-410), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-3090.

SUPPLEMENTARY INFORMATION: On December 28, 1988, ASAPS submitted a 
petition under section 513(e) of the Federal Food, Drug, and Cosmetic 
Act (the act) (21 U.S.C. 360c(e)), requesting that the suction 
lipoplasty system intended for surgical use in aesthetic body 
contouring, be reclassified from class III into class II. The major 
components of this system, the cannula (a manual surgical instrument 
for general use (21 CFR 878.4800)), and the suction pump (powered 
suction pump (21 CFR 878.4780)) when intended for certain uses other 
than suction lipoplasty procedures are classified in class I and class 
II, respectively. However, when these devices, individually labeled or 
combined into a system, are intended for use in aesthetic body 
contouring, they are automatically classified into class III under 
section 513(f)(1) of the act.
    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 agency to reclassify the device into class I or class II. 
FDA's regulations in 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 suction lipectomy 
system for use in aesthetic body contouring, it is necessary that the 
proposed new class has sufficient regulatory controls to provide 
reasonable assurance of the safety and effectiveness of the device for 
its intended use.
    Under the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 
310-394), (as amended by the Medical Device amendments of 1976 (the 
amendments) (Pub. L. 94-295), class II devices were defined as those 
devices for which there is insufficient information to show that 
general controls alone will ensure safety and effectiveness, but there 
is sufficient information to establish that performance standards would 
provide a reasonable assurance of safety and effectiveness of the 
device. In the time that has passed since the submission of the 
petition and the Panel meeting, the definition of class II devices has 
been amended by the Safe Medical Devices Act of 1990 (the SMDA). Under 
the SMDA, class II devices are those devices for which there is 
insufficient information to show that general controls alone will 
ensure safety and effectiveness, but there is sufficient information to 
establish special controls to provide such assurance, including the 
issuance of a performance standard, postmarket surveillance, patient 
registries, development and dissemination of guidelines, 
recommendations, and other appropriate actions the agency deems 
necessary (section 513(a)(B) of the act).
    It is the agency's position that is not necessary to obtain a new 
reclassification recommendation from a

[[Page 58196]]

Panel which had recommended reclassification into class II prior to the 
SMDA. If a Panel recommended that a device be reclassified from class 
III to 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.

I. Background

    In 1983 three firms submitted four premarket notifications to FDA 
under section 510(k) of the act (21 U.S.C. 360(k)) advising the agency 
of their intentions to place into commercial distribution either the 
suction cannula or the powered suction pump for use in suction 
lipoplasty for aesthetic body contouring. FDA determined that neither 
the suction cannula nor the powered suction pump for aesthetic body 
contouring was substantially equivalent to any preamendments device, 
nor was either device substantially equivalent to any postamendments 
device that had been classified into class I or class II for use in 
suction lipectomy for aesthetic body contouring. Accordingly, both 
devices were classified into class III under section 513(f)(1) of the 
act, and neither device could be placed in commercial distribution for 
use in suction lipoplasty for aesthetic body contouring unless it was 
reclassified under section 513(f)(2), or subject to an approved 
premarket approval application under section 515 of the act (21 U.S.C. 
360e).
    Subsequently, ASAPS initiated a clinical trial to identify the 
risks associated with suction lipoplasty procedures and to determine 
the relationship of the risks to characteristics of suction lipoplasty 
devices and thereby develop measures to minimize or control the risks 
(Ref. 1). After completing the clinical trial, ASAPS petitioned FDA to 
reclassify suction lipoplasty systems for use in aesthetic body 
contouring from class III into class II (Ref. 1). Consistent with the 
act and applicable regulations, the agency referred the petition to the 
Panel for its recommendation on the requested change in classification.

II. Recommendation of the Panel

    The Panel met on January 26, 1989, in a public meeting and on March 
10, 1989, via a telephone conference to discuss the suction lipoplasty 
systems intended for use in aesthetic body contouring. During the 
January 6, 1989, meeting, the Panel determined that additional data and 
information were indicated and that another panel meeting would be 
necessary to allow the Panel to address specific issues concerning the 
reclassification of the suction lipoplasty systems (Ref. 2). The Panel 
noted that the suction lipoplasty system is indicated for aesthetic 
body contouring (Ref. 2, p. 52) and is not intended to be a substitute 
for a weight reduction regimen. On March 10, 1989, after considering 
the device components and accompanying surgical risks as addressed in 
the petition and literature, the Panel recommended that the suction 
lipoplasty systems intended for aesthetic body contouring be 
reclassified from class III into class II (Ref. 3, p. 95). The Panel 
also recommended that FDA assign a high priority for the development of 
a performance standard for the generic type device.

III. Device Description

    The suction lipoplasty system 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 
sterile and 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, single or double 
rotary vane (oil or oil-less), single or double diaphragm, single or 
double piston, and a safety trap (Ref. 4). The pump meets the voluntary 
Underwriters Laboratories (UL) UL-455 Standards for Medical and Dental 
Equipment (Ref. 5). The collection bottle is calibrated to permit 
precise continual monitoring of the amount of material being removed 
from the patient. The cannulas are composed of biocompatible material 
such as plastic or surgical grade stainless steel with various 
dimensions and configurations determined by the particular application 
or surgical site and preference of the individual surgeon (Refs. 4, 6, 
and 7). The connecting tubing has an internal diameter appropriate to 
the size of the cannula handle, generally 7.5 to 12.5 millimeters. The 
tubing is able to withstand the amount of negative pressure created by 
the pump without collapsing.
    The device is used in the clinical field of plastic surgery for the 
purpose of aesthetic body contouring.

IV. Summary of Reasons for the Recommendation

    After reviewing the data and information contained in the petition 
and provided by FDA, and after consideration of the open discussions 
during the Panel meetings and the Panel members' personal knowledge of 
and clinical experience with the device system, the Panel gave the 
following reasons in support of its recommendation to reclassify the 
generic type suction lipoplasty system for use in aesthetic body 
contouring from class III into class II:
    (1) General controls by themselves are insufficient to provide 
reasonable assurance of the safety and effectiveness of the device.
    (2) There is sufficient publicly available information to establish 
a performance standard to provide reasonable assurance of the safety 
and effectiveness of the device for its intended use.
    (3) There is sufficient publicly available information to 
demonstrate that the risks to health and the performance parameters of 
the device have been characterized and that the relationship of these 
risks and performance parameters have been evaluated (Refs. 8, 11, and 
12).
    (4) Sufficient voluntary standards exist to reasonably assure the 
design and performance of the device system (Refs. 5, 13, 14, 15, 16, 
and 26).
    The Panel believed that current and any subsequent manufacturer of 
the suction lipoplasty system can comply with these voluntary standards 
and a performance standard; that FDA can assure the safety and 
effectiveness of device systems made by new manufacturers through 
premarket notification procedures under section 510(k) of the act; and 
that a regulatory level of class III is unnecessary to provide a 
reasonable assurance of safety and effectiveness.

V. Risks to Health

    The Panel determined that the foreseeable risks to health 
associated with the use of the suction lipoplasty system fall into two 
categories: (1) Those related to the device system that include the 
potential of infection of a subsequent patient resulting from the 
backflow of contaminated material trapped by the in-line filter during 
the preceding procedure, and (2) those related to the suction procedure 
that include tissue trauma (i.e., pain, nerve and blood vessel damage, 
hypesthesia, and hemorrhage). The degree of tissue trauma is believed 
to be related to the amount of vacuum applied and the type

[[Page 58197]]

of cannula used during the procedure (Refs. 10, 17, 18, and 19).
    After reviewing the Panel meeting transcripts, the petition, and 
the relevant literature, FDA identified other potential risks which 
include airborne bacterial or viral contamination of other patients and 
hospital personnel resulting from inefficient or overused in-line 
filters, patient bio-incompatibility to materials, and infection 
resulting from improper sterilization or practitioner handling.
    Several of the procedure-related risks reported in the literature 
(fat embolism, venous thrombosis, hematoma/seroma, pain, infection, 
necrosis/skin slough, edema, hypovolemia/hypotension, and potential 
death (Refs. 8, 11, 20, 21, 22, and 23)) were not observed in the 
petitioner's clinical studies and other procedure-related risks were 
reduced when the surgical procedure was performed by adequately trained 
surgeons on properly selected patients.
    In general, the best candidates for liposuction are healthy 
individuals who have concentrated areas of fat and firm, elastic 
skin. Age is usually a criterion for a healthy patient. However, 
after age 55, some patients lose skin elasticity and will not 
achieve the same good results as a younger patient.
    Liposuction is not recommended for patients with heart or lung 
diseases, poor blood circulation, diabetes, or those who have had 
recent surgery near the area of fat to be suctioned. Patients who 
are obese with diffuse areas of fat are not considered ideal 
candidates because of a greater risk of complications. However, in 
some cases, a series of carefully controlled procedures may be an 
effective adjunct to a weight-loss program.
(Ref. 24)

VI. Benefits

    Suction lipoplasty systems provide benefits to patients by 
effectively performing aesthetic body contouring. The benefits of these 
devices are probably best characterized in terms of patient 
satisfaction. The ASAPS study reported 56 percent of patients being 
very satisfied, 34 percent satisfied, and 6 percent not satisfied. Two 
other large studies reported overall satisfaction rates of 88 and 76 
percent, respectively (Refs. 8 and 9). Both studies found 
dissatisfaction rates highest in patients who had undergone liposuction 
of the buttocks. From the physicians' survey, review of the long-term 
results reveal that less than half of the respondents reported totally 
permanent results. Twenty nine percent reported fat ``regrowth'' as 
minimal and 62 percent were satisfied with the results.

VII. Summary Data Upon Which the Panel Recommendation is Based

    During its review and discussion of the petition, the Panel paid 
close attention to the potential risks and benefits to health 
associated with the use of the suction lipoplasty system and concluded 
that the data and information contained in the petition and presented 
by FDA demonstrated that the risks to health associated with this 
system could be adequately controlled (Ref. 1). The Panel relied on the 
following information in recommending that the suction lipoplasty 
system for aesthetic body contouring be class II devices.
    A 1988 ASAPS multicenter study (Ref. 1) provided some perspective 
of the above mentioned risks and complications. The study, using 2 
different suction pumps and connective tubing and 8 different cannulas, 
reported that of the 113 patients in whom 189 procedures had been 
performed, where the amount of fluid aspirated ranged from 15 to 4,700 
cubic centimeters per patient, there were no complications, undesired 
sequelae or health problems directly related to the device system used 
to perform liposuctions (Ref. 1, p. 24). The study also noted no 
mortality or episodes of shock, although 1 patient developed 
subcutaneous emphysema of the neck that was determined to be anesthesia 
related and 39 patients required postoperative transfusions. Other 
reported complication rates were hypesthesia, 46.6 percent; pain, 18.6 
percent; change in pigmentation, 10.6 percent; and scarring (thickening 
of the skin) during the immediate postoperative period, 9.9 percent. 
Additional complications which occurred in less than 5 percent of 
patients include asymmetry, waviness, insufficient fat removal, 
hematoma, excessive fat removal, and edema. Most of these complications 
improved or resolved with time resulting in an overall complication 
rate of 4.1 percent. Many of the items listed as complications in the 
study would be classified as undesirable sequela by other authors (Ref. 
1, p. 24).
    A 1987 American Society of Plastic and Rescontructive Surgery 
(ASPRS) task force studied the safety of liposuction. Eleven deaths and 
nine nonfatal serious complications over a 5-year period (an estimated 
100,000 cases) were documented (Ref. 12).
    Two other major studies on liposuction devices have been completed 
since the January 26, 1989, Panel recommendation. In 1989, a national 
survey of plastic surgeons was conducted. The findings of this survey 
identified a liposuction complication rate of 0.1 percent with 2 deaths 
among the 75,591 liposuction procedures analyzed in the survey. One 
death was caused by fat embolism and the other death by pulmonary 
thromboembolism. Twenty-five cases of deep venous thrombosis, 10 
transfusion complications, 9 cases of pulmonary thromboembolism, 5 
cases of major skin loss, 1 stroke, and 1 nonlethal fat embolus were 
reported (Ref. 11).
    In 1990, the Fornebu Clinic in Norway conducted a study involving 
3,511 liposuctions in 2,009 patients. It reported excessive bleeding in 
eight patients and anesthesia related complications in nine patients; 
however, no deaths, thromboembolic events, fat emboli or cardiovascular 
complications were reported (Ref. 8). Infection, an issue of particular 
concern to the Panel and to FDA, occurred in only 1 of the 2,009 
patients. The low incidence of infection associated with liposuction 
devices is confirmed and supported by several other reports in which 
the infection rate was less than 1 percent (Refs. 7, 8, 10, and 25).

VIII. Panel Recommendation

    The Panel concluded that the incidence of infections and other 
complications associated with liposuction using the suction lipoplasty 
system for aesthetic body contouring can be controlled by proper 
patient selection, utilization of the proper surgical technique, and 
restricting the use of the device to trained and experienced 
practitioners.
    Focusing on other potential problems and performance aspects of the 
device system, the Panel considered the issues of electrical 
malfunctions; bacterial, viral, or oil contamination of the operating 
room; bioincompatibility of materials; reflux of possible contaminated 
aspirated material; and product labeling.
    Regarding potential electrical malfunctioning of the components and 
properties of the device, the Panel believed that the UL-544 Standard 
for Medical and Dental Equipment (Ref. 2) can provide the necessary 
provisions to control the potential electrical hazards associated with 
the use of the suction pump. Likewise, the Panel believed that the 
American Society for Testing Materials (ASTM) F 960-86 Standard 
Specification for Medical and Surgical Suction and Drainage Systems can 
control the potential risk of leakage, risk of filtration, and 
implosion of the contaminants into the operating room by emissions from 
the exhaust port of the pump. Proper sterilization of the cannula and 
tubing can control the risk

[[Page 58198]]

of infection as indicated by the low rate of infection reported in the 
literature (Ref. 1, p. 29). The risk of oil vapor leakage can be 
reduced by properly maintaining the pump in oil based aspirators (Refs. 
1 and 4). The Panel noted that there are no reports of viral 
transmissions to operating room personnel from aerosolization of 
aspirate (Ref. 4).
    A major concern to the Panel was the reflux of possibly 
contaminated aspirated material from the collection bottle into the 
sterile surgical field. They concluded that filters and/or valves can 
minimize the potential risk of bacterial contamination of the cannula, 
surgical field, and operating room air.
    The Panel believed the biocompatibility of materials used to 
manufacture the cannula can be assessed by voluntary standards 
established by ASTM (Ref. 13), United States Pharmacopeia (USP) (Ref. 
14), and by methods described in Tripartite Biocompatibility Guidance 
for Medical Devices (Ref. 26), and that these test methods will provide 
reasonable assurance that the materials used to manufacture the device 
system, as well as any residues remaining on the devices after 
manufacturing, are not toxic and that the system is biocompatible. The 
Panel also believed that when the device is manufactured of materials 
that meet the specifications of existing voluntary standards, a 
biocompatible cannula can be produced thereby providing reasonable 
assurance of safety and effectiveness with respect to biocompatibility.
    The Panel believed that device labeling should reflect the nature 
of the device as it relates to the intended use and should include 
appropriate directions for use, warnings, and precautions, based upon 
current scientific knowledge. The Panel further believed that the 
labeling should be accessible to physicians and patients.
    In summary, the Panel believed that, based on publicly available 
valid scientific evidence, class II controls can provide reasonable 
assurance that the suction lipoplasty system is safe and effective for 
use in aesthetic body contouring. The Panel specified that the device 
conform to the provisions similar to those in the Tripartite 
Biocompatibility Guidance for Medical Devices, the above voluntary 
standards established by UL, ASTM, the Canadian Standards Association 
(CSA), the International Organization for Standardization (ISO), and 
USP, and specific labeling which identifies the appropriate patient 
selection criteria and surgeon training. The panel also recommended the 
issuance of a performance standard on a high priority basis.

IX. FDA's Tentative Findings

    FDA believes that the data provided by the petitioners and others 
constitute valid scientific evidence demonstrating that the regulatory 
controls of class II in combination with class I are sufficient to 
provide reasonable assurance of the safety and effectiveness of the 
generic type lipoplasty system as identified in section III. of this 
document. FDA tentatively agrees with the recommendation of the Panel 
that the suction lipoplasty system for aesthetic body contouring and 
substantially equivalent devices of this generic type should be 
reclassified from class III into class II. The agency has identified 
the special controls as the four following voluntary standards: 
International Organization for Standardization (ISO) 10079-1, Medical 
Suction Equipment, Part 1, Electrically Powered suction Equipment--
Safety Requirements, 1993 (Ref. 15); Canadian Standards Association 
(CSA), Standard Z168.11-94, Vacuum Devices Used for Suction and 
Drainage, 1994 (Ref. 16); Clinical Practice Guidelines, Plastic and 
Maxillofacial Surgery, American Society of Plastic and Reconstructive 
Surgeons, Chapter L: Localized Adiposity, September 1993 (Ref. 27); 
International Standard ISO-10993 Biological Evaluation of Medical 
Devices Part I Evaluation and Testing, 1995 (Ref. 28); and the 
inclusion of the following labeling statements to provide reasonable 
assurance of the safety and effectiveness of the suction lipoplasty 
system:
    (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 residency training or sanctioned continuing medical education, have 
demonstrated proficiency in suction lipoplasty.
    (3) This device will not, in and of itself, produce significant 
weight reduction.
    (4) This device should be used with extreme caution in patients 
with chronic medical conditions such as diabetes, heart or lung 
disease, circulatory diseases, or obesity.
    (5) Results of this procedure will vary depending upon patient age, 
surgical site, and experience of the surgeon.
    (6) Results of this procedure may or may not be permanent.
    (7) The amount of fat removed should be limited to that necessary 
to achieve a desired cosmetic effect.
    (8) Loss of blood and fluid is predictable based on suction volume. 
Capability of providing adequate, timely replacement of these 
components is essential for patient safety.
    (9) All reusable components of the device must be sterilized 
between patients and all disposable components replaced.
    FDA does not believe that the performance standard recommended by 
the Panel is necessary because the voluntary standards listed above 
will provide a reasonable assurance of safety and effectiveness for the 
suction lipectomy system.
    Consistent with the purpose of the act, class II controls as 
identified above and as defined by section 513(a)(1)(B) of the act are 
sufficient to provide reasonable assurance of the safety and 
effectiveness of the suction lipoplasty system.

X. Environmental Impact

    The agency has determined under 21 CFR 25.24(e)(2) 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.

XI. Analysis of Impacts

    FDA has examined the impacts of this proposed action under 
Executive Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-
354). 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 action is consistent with the regulatory 
philosophy and principles identified in the Executive Order. In 
addition, the proposed action 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. Because reclassification of devices relieve 
manufacturers of the cost of complying with the premarket approval 
requirements of section 515 of the act, and may permit small potential 
competitors to enter the marketplace by lowering their costs, the 
agency certifies that this proposed action would not have a significant 
economic impact on

[[Page 58199]]

a substantial number of small entities. Therefore, under the Regulatory 
Flexibility Act, no further analysis is required.

XII. References

    The following references have been placed on display in the 
Documents Management Branch (address above) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
    1. Reclassification Petition for the Suction Lipectomy Systems 
for Aesthetic Body Contouring, submitted by American Society for 
Aesthetic Surgery, December 28, 1989.
    2. Transcript of the General and Plastic Surgery Devices Panel 
Meeting, January 26, 1989.
    3. Transcript of the General and Plastic Surgery Devices Panel 
Meeting, March 10, 1989.
    4. Pitman, G. H., ``Instrumentation,'' Liposuction and Aesthetic 
Surgery, Quality Medical Publishing Inc., St. Louis, MO, Part I, 
2:31-36.
    5. Underwriters Laboratories, UL-544, Standard for Medical and 
Dental Equipment, 1976, Reprinted 1985.
    6. Illouz, Y. G., ``Illouz's Technique of Body Contouring by 
Lipolysis,'' Clinics in Plastic Surgery, 11:409-417, 1984.
    7. Kesselring, U. K., ``Body Contouring with Suction 
Lipectomy,'' Clinics in Plastic Surgery, 11:393-498, 1984.
    8. Dillerud, E., ``Suction Lipoplasty, A Report on 
Complications, Undesired Results, and Patient Satisfaction Based on 
3,511 Procedures,'' Plastic and Reconstructive Surgery, 88:239-246, 
August 1991.
    9. Dillerud, E., and L. L. Haheim, ``Long-term Results of Blunt 
Suction Lipectomy Assessed By Questionnaire Survey,'' Plastic and 
Reconstructive Surgery, 92:35-42, July 1993.
    10. Dolsky, R. L., J. Newman, J. R. Fetzek, et al., 
``Liposuction History, Techniques and Complications,'' Dermatology 
Clinics of North America, 5:313-333, 1987.
    11. Teimourian, B. and W. B. Rogers, ``A National Survey of 
Complications Associated with Suction Lipectomy: A Comparative 
Study,'' Plastic and Reconstructive Surgery, 84:628-631, 1989.
    12. Fredricks, S., ``Five-year Updated Evaluation of Suction-
assisted Lipectomy,'' ASPRS Ad Hoc Committee on New Procedures, 
September 30, 1987.
    13. Annual Book of American Society for Testing and Materials 
Standards, Medical Devices, vol. 13.01, 1088.
    F 639-79 Standard Specification for Polyethylene Plastics for 
Medical Applications.
    F 665-80 Standard Classification for Vinyl Chloride Plastics 
Used in Biomedical Application.
    F 719-81 Standard Practice for Testing Biomaterials in Rabbits 
for Primary Skin Irritation.
    F 720-81 Standard Practice for Testing Guinea Pig Maximization 
Test.
    F 748-87 Standard Practice for Selecting Generic Biological Test 
Method for Materials and Devices.
    F 749-87 Standard Practice for Evaluating Material Extracts by 
Intracutaneous Injection in the Rabbit.
    F 750-87 Standard Practice for Evaluating Material Extracts by 
Systemic Injection in the Mouse.
    F 813-83 Standard Practice for Direct Cell Culture Evaluation of 
Materials for Medical Devices.
    F 960-86 Standard Specification for Medical and Surgical Suction 
and Drainage Systems.
    14. United States Pharmacopeia XXI, Biological Tests--Plastics.
    15. ISO (International Organization for Standardization) 10079-
1, Medical Suction Equipment, Part I, Electrically Powered Suction 
Equipment--Safety Requirements, 1993.
    16. CSA (Canadian Standards Association), Standard Z168.11-94, 
Vacuum Devices Used for Suction and Drainage, 1994.
    17. Grazer, F. M., ``Suction-Assisted Lipectomy: Its 
Indications, Contraindications, and Complications,'' Year Book 
Medical Publishers, 1984.
    18. Ersek, R. A., J. Zambrona, G. S. Surak, et al., ``Suction-
assisted Lipectomy for Correction of 202 Figure Faults in 101 
Patients: Indications, Limitations, and Applications,'' Plastic and 
Reconstructive Surgery, 78:615-626, 1986.
    19. Hetter, G. P., ``Optimum Vacuum Pressures for Lipolysis,'' 
Aesthetic Plastic Surgery, 8:23-26, 1984.
    20. Christman, K. D., ``Death Following Lipectomy and Tissue,'' 
``Neither Panacea of Humbug,'' Postgraduate Medicine, 75:124, 126, 
128, 1984.
    21. Courtiss, E. H., ``Suction Lipectomy: A Retrospective 
Analysis of 100 Patients,'' Plastic and Reconstructive Surgery, 
73:780-796, 1984.
    22. Badran, H. A., K. Z. Kodeara, and M. H. Mabrouk, ``Blood 
Conservation in Massive Suction Lipectomy,'' Plastic and 
Reconstructive Surgery, 92:1298-1304, 1993.
    23. Hunter, G. R., R. O. Crapo, and T. R. Broadbent, ``Pulmonary 
Complications Following Abdominal Lipectomy,'' Plastic and 
Reconstructive Surgery, 71:809-817, 1983.
    24. Backgrounder, ``Liposuction'' American Society of Plastic 
and Reconstructive Surgeons, July 1994.
    25. Pitman, G. H., and B. Teimourian, ``Suction Lipectomy: 
Complications and Results by Survey,'' Plastic and Reconstructive 
Surgery, 76:65-72, 1985.
    26. Tripartite Biocompatibility Guidance for Medical Devices, 
September 1986.
    27. Clinical Practice Guidelines, Plastic and Maxillofacial 
Surgery, American Society of Plastic and Reconstructive Surgeons, 
Chapter L: Localized Adiposity, September 1993.
    28. International Standard ISO-10993 Biological Evaluation of 
Medical Devices Part I Evaluation and Testing, 1995.

XIII. Request for Comments

    Interested persons may, on or before February 11, 1997, submit to 
the Dockets Management Branch (address above) written comments 
regarding this document. Two copies of any comments are to be 
submitted, except that individuals may submit one 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 office above 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: November 6, 1996.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 96-29066 Filed 11-12-96; 8:45 am]
BILLING CODE 4160-01-F