[Federal Register Volume 69, Number 152 (Monday, August 9, 2004)]
[Rules and Regulations]
[Pages 48146-48148]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-18074]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. 2002N-0500]


General and Plastic Surgery Devices; Classification of Silicone 
Sheeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is classifying silicone 
sheeting intended for use in the management of closed 
hyperproliferative (hypertrophic and keloid) scars into class I 
(general controls). As a class I device, the device will be exempt from 
premarket notification requirements. This action is taken under the 
Federal Food, Drug, and Cosmetic Act (the act), as amended by the 
Medical Device Amendments of 1976 (the 1976 amendments), the Safe 
Medical Devices Act of 1990 (the SMDA), the Food and Drug 
Administration Modernization Act of 1997 (FDAMA), and the Medical 
Devices User Fee Modernization Act of 2002 (MDUFMA).

DATES: This rule is effective September 8, 2004.

FOR FURTHER INFORMATION CONTACT: Sam R. Arepelli, Center for Devices 
and Radiological Health (HFZ-410), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-3090.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of March 20, 2003 (68 FR 13639), FDA issued 
a proposed rule to classify silicone sheeting intended to manage 
hyperproliferative scars on intact skin into class I based on available 
information regarding this device, including the recommendation of the 
General and Plastic Surgery Devices Panel (the Panel). The device is 
intended for use in the management of closed hyperproliferative 
(hypertrophic and keloid) scars. FDA invited interested persons to 
comment on the proposed rule by June 18, 2003.

II. Summary of the Comments and FDA's Response

    FDA received two comments on the proposed rule. One comment 
supported the proposed classification. The other comment expressed 
concerns about the proposal to classify the device into class I and 
exempt it from premarket notification. The comment recommended that FDA 
require premarket notification for silicone sheeting as recommended by 
the Panel. Specifically:
    1. The comment stated that the proposed classification conflicts 
with the July 8, 2002, Panel recommendation of classification into 
class I subject to general controls, including premarket notification.
    We agree that the Panel's recommendation was that this device be 
classified into class I subject to general controls, including 
premarket notification. Under the act, however, class I devices are 
presumptively exempt from premarket notification unless the class I 
device is ``intended for a use which is of substantial importance in 
preventing impairment of human health,'' or ``presents a potential 
unreasonable risk of illness or injury'' (section 510(l) of the act (21 
U.S.C. 360(l))). In response to the specific question of whether this 
device is ``for a use which is of substantial importance in preventing 
impairment of human health,'' the Panel responded no. In response to 
the question of whether the device ``present[s] a potential 
unreasonable risk of illness or injury,'' the Panel again responded no. 
Thus, although the Panel's recommendation was that FDA require 
premarket notification, when asked whether the device presented the 
specific characteristics that would prevent exempting the device from 
premarket notification under section 510(l) of the act, the Panel's 
response was no.
    As discussed in the proposed rule (68 FR 13639), FDA's experience 
with similar device types, specifically four other types of wound 
dressings, has demonstrated that classification as class I and 
exemption from premarket notification provide a reasonable assurance of 
safety and effectiveness. FDA believes that its experience with these 
devices is directly relevant to this determination and supports the 
exemption of this device from premarket notification. As discussed 
later in this document, FDA also believes this device presents a low 
risk to health and that premarket notification is not necessary to 
provide reasonable assurance of the safety and effectiveness of the 
device.
    Finally, FDA is not required to follow the Panel's recommendations, 
(section 513(b)(7) of the act (21 U.S.C. 360c(b)(7))) and for the 
reasons outlined in this preamble, FDA has determined that exempting 
this device from premarket notification requirements is appropriate.
    2. The comment also stated that there is insufficient valid 
scientific evidence from prospective randomized clinical trials that: 
(1) Shows that the device is effective in either alleviating the 
symptoms or improving the appearance of hypertrophic or keloid scars, 
and (2) explains the device's mechanism of action. The comment further 
stated that keloid scars are more common among African-Americans and 
Asian-Americans and that no studies have investigated the effectiveness 
of silicone sheeting on a representative number of individuals across 
racial, sexual, or age categories.
    FDA agrees in part. FDA reviewed the cited literature relating to 
this comment, as well as all other publicly available information on 
the device type. FDA acknowledges that the literature on this 
preamendments device does not demonstrate that silicone sheeting alone 
alleviates the symptoms or improves the appearance of hypertrophic or 
keloid scars, and that the literature does not focus on the performance 
of the device in specific ethnic or racial groups.
    Consistent with the Panel's recommendation, however, FDA believes 
that class I is the appropriate classification for silicone sheeting

[[Page 48147]]

intended for use in the management of closed hyperproliferative 
(hypertrophic and keloid) scars. This device is used in conjunction 
with other standard scar care treatments and provides a physical 
barrier between the scar and the environment, keeping the scar moist 
and clean, thus contributing to an improved overall outcome for the 
patient. The comment on the lack of consensus on the precise mechanism 
for action does not bear upon the safety or effectiveness of the 
device. The panel did discuss whether this device is appropriate for 
use on open wounds, however. To address these concerns, FDA has amended 
the intended use statement to more clearly reflect that the device is 
to be used in the management of closed scars.
    FDA also notes that silicone sheeting for this particular intended 
use has a long history of safe use and that the risks to health posed 
by the use of the device are low. In fact, the Panel did not identify 
any risks to health associated with its use. Moreover, there have been 
only two medical device adverse event reports for this device over a 
span of several decades of use. The agency believes that classifying 
the device as class I and exempting it from premarket notification is 
appropriate for a device that poses a low risk to health and that is 
used in conjunction with other standard treatments.
    3. The comment stated that FDA should consider the risks of off-
label uses of silicone sheeting and stated that the device is marketed 
to surgeons as intended for use in the repair of fractured orbital 
floors, among other uses. The comment continued
    ``[i]f manufacturers are permitted to market silicone sheeting 
for any use, without any proof of safety, then the public's health 
is at risk. The labeling requirements in a premarket notification 
provide some measure of assurance. If silicone sheeting is 
classified as class I, there will be fewer safeguards to protect 
patients.''
    FDA disagrees with this part of the comment for the following 
reasons:
     This comment appears to misunderstand the scope of this 
classification and exemption. FDA has classified into class I and 
exempted only silicone sheeting intended for use in the management of 
closed hyperproliferative (hypertrophic and keloid) scars. Silicone 
sheeting for other intended uses would be subject to a limitations of 
exemptions analysis under section 510(l) of the act and Sec.  878.9 (21 
CFR 878.9). Under this regulation, a premarket notification must be 
submitted when a device is intended for a use different from the 
intended use of a legally marketed device in that ``generic type'' of 
device (Sec.  878.9(a)). Thus, silicone sheeting for other intended 
uses may be required to submit a premarket notification. Certain uses 
could require a premarket approval application (PMA). This action does 
not authorize manufacturers to market silicone sheeting for any use 
other than the intended use stated in the device identification.
     The comment also states that the labeling requirements in 
a premarket notification provide some measure of assurance. FDA agrees 
that proposed labeling is required as part of the premarket 
notification submission (21 CFR 807.87(e)); however, the proposed 
labeling is submitted only as a means of describing the device and its 
intended use for the purpose of making a substantial equivalence 
determination (section 513(i)(1)(E) of the act (21 U.S.C. 
360c(i)(1)(E)).
    Section 513(i)(1)(E) of the act also states that, as part of a 
substantial equivalence determination, FDA may require information in 
the labeling regarding an off-label use if there is a reasonable 
likelihood that the device will be used for an intended use not 
identified in the proposed labeling for the device and that such use 
could cause harm. In the case of silicone sheeting intended for use in 
the management of closed hyperproliferative scars, however, FDA does 
not believe that the criteria in section 513(i)(1)(E) of the act would 
be met. The widespread availability of medical grade silicone materials 
make it unlikely that silicone sheeting intended for use in the 
management of closed hyperproliferative (hypertrophic and keloid) scars 
will contribute to any significant off-label use.
    The adulteration and misbranding provisions of the act (sections 
501 and 502 of the act (21 U.S.C. 351 and 352)) will help ensure that 
the device is appropriately labeled and has a reasonable assurance of 
safety and effectiveness. These provisions are applicable to all 
devices, including class I devices exempt from premarket notification. 
If these provisions are violated, FDA has the authority to take 
enforcement action.
    4. The comment stated that the proposed intended use of the device 
in the proposed identification statement regarding use ``on 
hyperproliferative (hypertrophic) scars on intact skin'' is 
inconsistent because hypertrophic scars are considered as compromised 
(not intact) skin.
    FDA partially agrees. On further review of the panel transcript, 
FDA believes that the intent of the panel was for use of the device 
``on closed hyperproliferative (hypertrophic and keloid) scars.'' FDA 
is accordingly revising the identification to ``Silicone sheeting is 
intended for use in the management of closed hyperproliferative 
(hypertrophic and keloid) scars.''
    5. Lastly, the comment urged that ``as an implanted product'' this 
device should be classified into class III.
    FDA notes that the device classified is not an implanted product, 
but rather one intended for topical use on closed scars. Thus, this 
comment is not applicable to the device being classified.

III. FDA's Conclusion

    Based on a review of the available information in the preamble to 
the proposed rule and placed on file in FDA's Division of Dockets 
Management and for the reasons stated previously, FDA concludes that 
general controls will provide reasonable assurance of the safety and 
effectiveness of silicone sheeting intended for use in the management 
of closed hyperproliferative (hypertrophic and keloid) scars. 
Therefore, FDA is classifying the device into class I.
    Also, based on the reasons discussed previously, FDA believes that 
premarket notification is not required to provide a reasonable 
assurance of the safety and effectiveness of this device. Additionally, 
FDA believes that silicone sheeting intended for use in the management 
of closed hyperproliferative (hypertrophic and keloid) scars does not 
meet the reserved criteria in section 510(l) of the act.

IV. Environmental Impact

    The agency has determined under 21 CFR 25.34(b) that this 
classification 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 isrequired.

V. Analysis of Impacts

    FDA has examined the impacts of the final 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

[[Page 48148]]

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. As noted previously, FDA may classify devices into 
one of three regulatory classes according to the degree of control 
needed to provide reasonable assurance of safety and effectiveness. FDA 
is classifying this device into class I, the lowest level of control 
allowed. In addition, the device is exempt from premarket notification 
requirements. The agency, therefore, certifies that this final rule 
will not have a significant 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 $110 million. FDA does not expect this 
final rule to result in any 1-year expenditure that would meet or 
exceed this amount. In addition, it 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.

VI. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has 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.

VII. Paperwork Reduction Act of 1995

    This final rule contains no collections of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3501-3520) is not required.

List of Subjects in 21 CFR Part 878

    Medical devices.

0
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

0
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.

0
2. Section 878.4025 is added to subpart E to read as follows:


Sec.  878.4025  Silicone sheeting.

    (a) Identification. Silicone sheeting is intended for use in the 
management of closed hyperproliferative (hypertrophic and keloid) 
scars.
    (b) Classification. Class I (general controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to the limitations in Sec.  878.9.

    Dated: July 28, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-18074 Filed 8-6-04; 8:45 am]
BILLING CODE 4160-01-S