[Federal Register Volume 68, Number 54 (Thursday, March 20, 2003)]
[Proposed Rules]
[Pages 13639-13641]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-6646]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. 02N-0500]


General and Plastic Surgery Devices; Classification of Silicone 
Sheeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to 
classify silicone sheeting intended to manage hyperproliferative 
(hypertrophic and keloid) scars on intact skin into class I (general 
controls) and to exempt the device from premarket notification. The 
agency is publishing the recommendation of the General and Plastic 
Surgery Devices Panel (the Panel) regarding the classification of this 
device. After considering public comments on the proposed 
classification, FDA will publish a final regulation classifying this 
device. This action is being taken to establish sufficient regulatory 
controls that will provide reasonable assurance of the safety and 
effectiveness of this device. 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 (MDUFMA).

DATES: Submit written or electronic comments by June 18, 2003. See 
section XI of this document for the proposed effective date of a final 
rule based on this document.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.

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

    The act (21 U.S.C. 301 et seq.), as amended by the 1976 amendments 
(Public Law 94-295), the SMDA (Public Law 101-629), and FDAMA (Public 
Law 105-115), 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 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 preamendements 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.
    A device that was not in commercial distribution before May 28, 
1976, generally referred to as postamendments device, is 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: (1) The device is 
reclassified into class I or II; (2) FDA issues an order classifying 
the device into class I or II in accordance with new section 513(f)(2) 
of the act, as amended by FDAMA; or (3) 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 the premarket notification 
procedures in section 510(k) of the act (21 U.S.C. 360(k)) and 21 CFR 
part 807.
    A preamendments device that has been classified into class III may 
be marketed, by means of the 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).
    In the Federal Register of June 24, 1988 (53 FR 23856), FDA 
published a final rule classifying most general and plastic surgery 
devices. At that time, FDA was not aware that silicone sheeting 
intended to manage hyperproliferative scars was a preamendments device 
and inadvertently omitted classifying it. Consistent with the act and 
the regulations, FDA consulted with the Panel, an FDA advisory 
committee, regarding the classification of this device.
    FDAMA added a new section 510(1) to the act. New section 510(1) of 
the act provides that a class I device is exempt from the premarket 
notification requirements under section 510(k) of the act, unless the 
device is intended for use which is of substantial importance in 
preventing impairment of human health or it presents a potential 
unreasonable risk of illness or injury. Hereafter, these are referred 
to as ``reserved criteria.'' The general exemption for class I devices 
permits manufacturers to introduce certain generic types of devices 
into commercial distribution without first submitting a premarket 
notification to FDA.

II. Device Description

    FDA is proposing the following device description based on the 
Panel's recommendations and the agency's review: Silicone sheeting is 
intended to manage hyperproliferative (hypertrophic and keloid) scars 
on intact skin.

III. Recommendation of the Panel

    In a public meeting held on July 8, 2002, the Panel voted (six to 
zero with one abstention) to recommend that silicone sheeting intended 
to manage hyperproliferative scars on intact skin be classified into 
class I (Ref. 1). The Panel also believed that the device meets the 
reserved criteria of new section 510(1) of the act and should require 
premarket notification. The Panel also recommended prescription use of 
the device.

IV. Summary of Reasons for the Recommendation

    The Panel concluded that the safety and effectiveness of silicone 
sheeting intended to manage hyperproliferative scars on intact skin 
could be reasonably assured by general controls. Specifically, the 
Panel believed that the safety and effectiveness of the device can be 
reasonably assured by: (1) Registration and listing (section 510 of the 
act), (2) good manufacturing practices requirements (section 520(f) of 
the act (21 U.S.C. 360j(f)), (3) premarket notification (section 510(k) 
of the act), and (4) general requirements concerning reports (21 CFR 
820.120) and complaint files (21 CFR 820.198).

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V. Risks to Health

    The Panel identified no risks to health associated with the use of 
silicone sheeting intended to mange hyperproliferative scars. They 
noted that the device is intended for use on intact skin and commented 
that no allergic reactions are associated with its use.

VI. Summary of the Data Upon Which the Proposed Recommendation is Based

    The Panel based its recommendation on the information provided by 
FDA, the presentations made by manufacturers and FDA at the Panel 
meeting, the open discussion during the Panel meeting, and the Panel 
members' personal knowledge of and clinical experience with the device.

VII. FDA's Tentative Findings

    FDA tentatively agrees with the recommendation of the Panel that 
silicone sheeting intended to manage hyperproliferative scars on intact 
skin should be classified into class I because the agency believes that 
sufficient information exists to determine that general controls would 
provide reasonable assurance of safety and effectiveness.
    FDA tentatively disagrees with the recommendation of the Panel that 
silicone sheeting meets the reserved criteria of new section 510(1) of 
the act and that it should be a prescription device. FDA does not 
believe that the device is of substantial importance in preventing 
impairment of human health or that it presents a potential unreasonable 
risk of illness or injury, and therefore has determined that it should 
be exempt from premarket notification. FDA also has determined that 
prescription use of the device is unnecessary.
    FDA notes that four wound dressing products that are intended to 
cover wounds on non-intact skin currently are adequately regulated as 
class I devices that are exempt from premarket notification procedures 
and as nonprescription use devices. These devices are the nonresorbable 
gauze/sponge for external use (21 CFR 878.4014), the hydrophilic wound 
dressing (21 CFR 878.4018), the occlusive wound dressing (21 CFR 
878.4020), and the hydrogel wound and burn dressing (21 CFR 878.4022). 
Because silicone sheeting is intended for use on intact skin, the 
agency believes that the same regulatory control that reasonably 
assures the safety and effectiveness of these four wound dressings 
intended for use on non-intact skin, i.e., regulation as a 
nonprescription use class I device exempt from premarket notification, 
is adequate to reasonably assure the safety and effectiveness of 
silicone sheeting. Therefore, the agency is proposing that silicone 
sheeting intended to manage hyperproliferative scars on intact skin be 
classified into class I and that it be exempt from premarket 
notification.

VIII. Environmental Impact

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

IX. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Public Law 96-354) (as 
amended by subtitle D of the Small Business Regulatory Fairness Act of 
1996 (Public Law 104-121), 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 consistent with 
the regulatory philosophy and principles identified in the Executive 
order. In addition, the proposed 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 proposing that this device be classified into class I, the lowest 
level of control allowed. In addition, FDA is proposing to exempt it 
from premarket notification requirements. The agency, therefore, 
certifies that this proposed rule will not have a significant impact on 
a substantial number of small entities. 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.

X. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed 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.

XI. Submission of Comments and Proposed Dates

    You may submit to the Dockets Management Branch written or 
electronic comments regarding this proposal. You must submit two copies 
of any mailed comments, except that individuals may submit one copy. 
You should identify comments with the docket number found in brackets 
in the heading of this document. Comments are available for public 
examination in the Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday. FDA proposes that any final rule that may issue 
based on this proposal become effective 90 days after its date of 
publication in the Federal Register.

XII. Reference

    The following reference has been placed on display in the Dockets 
Management Branch (see ADDRESSES) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. General and Plastic Surgery Devices Panel, meeting 
transcript, pp. 1-82, July 8, 2001.

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, it is 
proposed that 21 CFR part 878 be 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 878.4025 is added to subpart E to read as follows:


Sec.  878.4025  Silicone sheeting.

    (a) Identification. Silicone sheeting is intended to manage 
hyperproliferative (hypertrophic and keloid) scars on intact skin.
    (b) Classification. Class I (general controls). The device is 
exempt from the

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premarket notification procedures in subpart E of part 807 of this 
chapter subject to the limitations in Sec.  878.9.

    Dated: December 24, 2002.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-6646 Filed 3-19-03; 8:45 am]
BILLING CODE 4160-01-S