**M E M O R A N D U M**

**Date:** June 11, 2002

**To:** General and Plastic Surgery Devices Panel

**From:** Sam R. Arepalli, Ph.D.

**Subject:** Classification of the Scar Management Device

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Inadvertently a few medical devices were not classified at the time of
Medical Device Amendments of 1976 (the 1976 Amendments) to the Food,
Drug and Cosmetic Act (the Act) (21 USC 360C). These medical devices are
currently regulated as unclassified devices via premarket notification
(510(k)).

The 1976 Amendments as amended by the Safe Medical Device Act (SMDA) of
1990 and the FDA Modernization Act (FDAMA) of 1997 provide regulations
for the classification and regulation of medical devices intended for
human use. FDA is required to classify all medical devices, including
the remaining unclassified medical devices into the lowest regulatory
class that can reasonably assure their safety and effectiveness for
their intended use.

The Act established three categories (classes) of medical devices
depending on the regulatory controls needed to provide reasonable
assurance of their safety and effectiveness. The three classes are Class
I (general controls), Class II (special controls), and Class III
(pre-market approval). General controls are sufficient to provide
reasonable assurance of the safety and effectiveness of Class I devices.
General controls include the following: prohibition against adulterated
or misbranded devices, premarket notification (510(k)), banned devices,
the quality system regulation that includes design controls and good
manufacturing processes (GMPs), registration of manufacturing
facilities, listing of device types, record keeping, etc. Class II
devices are those that cannot be classified into Class I because general
controls by themselves are insufficient to provide reasonable assurance
of the safety and effectiveness of such devices. These devices are
regulated using special controls and general controls. Special controls
include guidelines (guidance documents), performance standards,
postmarket surveillance, clinical data, labeling, tracking requirements,
and other appropriate actions the Secretary of the Department of Health
and Human Services deems necessary to provide such assurance. Class III
devices are those for which insufficient information exists to determine
that general and special controls are sufficient to provide reasonable
assurance of the safety and effectiveness. These devices are life
sustaining, life supporting, or substantially important in preventing
impairment of human health, or they present unreasonable risk of illness
or injury. Class III devices are regulated by using "valid scientific
evidence" to establish the safety and effectiveness of the device. Valid
scientific evidence includes well-controlled investigations,
partially-controlled studies, uncontrolled studies, well-documented case
histories, and reports of significant human experience.

When most device types were classified in the late 1970s and early
1980s, most Class I and Class II devices were cleared for marketing via
the 510(k) process. Some Class I devices were also exempted from 510(k)
clearance. Now many Class I devices and a few Class II devices are
exempt from 510(k) clearance because their safety and effectiveness can
be reasonably assured by other general controls, particularly by the
quality system regulation general control. Examples of class I exempt
products include hydrogel wound dressings, manual surgical instruments.
Class II devices include implantable surgical meshes, sutures, dura
mater substitute devices etc. Class III devices include Interactive
Wound Dressings, Adhesion Barriers etc.

FDA has regulated silicone sheeting intended for scar management as an
unclassified pre-amendment medical device. It has been cleared for
marketing under several names, including silicone sheeting, silicone
elastomer, and silicone gel for hypertrophic and keloid scar management.
Also, the agency cleared a hydrogel for the same intended use.

Your panel package includes information on the classification of medical
devices. Please note that some slides of the presentation in Tab 1b on
Device Classification/ Reclassification Procedures have an asterisk
(\*). The asterisked slides pertain to the classification of
unclassified preamendment devices and are relevant to the classification
of the scar management device. Tab 1b also contains the questionnaire
that you will vote on as part of your recommendation on the
classification of this device. Tab 1c lists our panel discussion topics
for the classification of this device. Tab 1d includes the only two
medical device reports (MDR) on the device. Tab 1e is a bibliography of
13 articles on the clinical use of silicone sheeting and 1 article on
the clinical use of a hydrogel for the intended use of scar management.

**Risks to Health**

FDA is proposing the following identification for the scar management
device: A scar management device is a silicone sheeting product intended
for use on uncompromised skin for scar management.

FDA regulates several silicone devices as Class III, Class II, Class I
and unclassified devices. For example, the breast implant device, which
has a silicone envelope and may contain a silicone gel filler is
regulated as Class III medical device. Silicone chin, facial, etc.
implants are regulated as Class II medical devices. Several other
medical devices made of silicone are Class I devices and are exempt from
510(k) requirements (ex: drainage tubes). Silicone sheeting intended for
the scar management is currently regulated as an unclassified medical
device. Unlike the other silicone devices mentioned above, silicone
sheeting intended for scar management is used on uncompromised skin.

FDA believes that the risk to health i.e., possible adverse skin
reaction due to lack of biocompatibility exists.

FDA cleared about fifty pre-market notification (510(k)) applications
for the scar management devices in the last five years. We searched
medical device reports for the device adverse events. There are two
adverse events reported (Tab 1e). The first adverse event was a
significant blistering caused shortly after using gel sheeting followed
by full thickness skin necrosis due to secondary infection. The
blistering was not at the site of gel sheeting application, but in the
areas nearby. It was determined by the reporting physician that the
event was unrelated to the device but we could not rule out the
possibility of the device involved. The other adverse event was severe
red rash and flaky rough skin. This was determined as an isolated event
and not likely that it was due to the use of the device.

The next page after this memorandum is a proposed regulatory
identification for the scar management device.

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Sam Arepalli, Ph.D. Date

FDA/CDRH/ODE/DGRND/PRSB