SWD devices are currently classified in Class III. In light of the information available now, the Panel will be asked to comment on whether SWD fulfills the statutory definition associated with a Class III device designation. FDA believes that these devices may be more appropriately regulated as:
Class II, meaning general and special controls are sufficient to provide reasonable assurance of its safety and effectiveness
As opposed to:
Class III, meaning
o insufficient information exists to determine that general and special controls are sufficient to provide reasonable assurance of its safety and effectiveness, and the device is life-supporting or life-sustaining, or for a use which is of substantial importance in preventing impairment of human health, or if the device presents a potential unreasonable risk of illness or injury.
For nonthermal SWD devices, FDA believes that the available evidence suggests that special controls can be used to provide a reasonable assurance of safety and effectiveness. Special controls can be defined to address safety; for example, compliance with electrical safety standards, or adequate labeling. FDA also recommends that special controls include a requirement for clinical performance data to establish effectiveness for nonthermal SWD devices for specific output parameters and clinical conditions.
Sentiment: Strong Buy