The US Food and Drug Administration (FDA) has announced that it will soon classify surgical instruments intended to improve "the appearance of cellulite" as Class II medical devices, making it easier for them to be brought to market.
In the US, medical devices are regulated by FDA's Center for Devices and Radiological Health (CDRH) and subject to three general classifications:
- Class I (for low-risk devices)
- Class II (moderate-risk devices)
- Class III (high-risk devices)
While Class III devices almost always require the submission of a premarket application (PMA) and require prior approval, and Class I devices generally only require a company to notify FDA that a device is being marketed, Class II devices represent something of a compromise.
If FDA has set standards for a Class II device, sponsors must submit a premarket notification (usually referred to as a 510(k) application) certifying that the device meets both general controls to ensure device safety and efficacy and special controls meant to address the unique concerns of a specific type of device.
In return, FDA is able to grant marketing clearance to a device relatively quickly, avoiding the time-consuming PMA process, which generally takes a case-by-case approach to evaluating devices and requires the submission of clinical data.
Special Controls Established
The latest order, affecting Powered Surgical Instrument for Improvement in the Appearance of Cellulite, comes after a lengthy back-and-forth between FDA and Cabochon Aesthetics, Inc, which had submitted a request for classification to FDA.
In 2011, FDA had classified the device as a Class III medical device because it "was not substantially equivalent to a device that was introduced or delivered for introduction into interstate commerce" prior to the 1976 Medical Device Amendments to the Federal Food, Drug and Cosmetic Act.
Cabochon appealed FDA's decision, and pressed the agency to recognize its Cabochon System as a Class II device.
On 12 July 2013, FDA said it agreed, and issued an order that the device be classified as a Class II device.
Now the agency is opening up a similar avenue to all such devices, establishing special controls at 21 CFR 878.4790.
"Following the effective date of this final classification administrative order, any firm submitting a premarket notification (510(k)) for a powered surgical instrument for improvement in the appearance of cellulite will need to comply with the special controls named in the final administrative order," FDA explained.
The noted risks that must be controlled for include mechanical injury, infection, electrical shock, electromagenetic interference, adverse tissue reactions and use errors. As such, the following special controls must be established:
- Non-clinical testing must be performed to demonstrate that the device meets all design specifications and performance requirements, and to demonstrate durability and mechanical integrity of the device.
- In vivo evaluation of the device must demonstrate device performance, including the safety of the release methodology and blood loss at the treatment sites.
- All elements of the device that may contact the patient must be demonstrated to be biocompatible.
- Electrical safety and electromagnetic compatibility of the device must be demonstrated.
- The labeling must include a summary of in vivo evaluation data and all the device specific warnings, precautions, and/or contraindications.
- Sterility and shelf-life testing for the device must demonstrate the sterility of patient contacting components and the shelf life of these components.
According to statements by Cabochon, the devices are minimally invasive and used to eliminate (by cutting) and vacuum out cellulite, similar to liposuction procedures. According to FDA's 510(k) clearance notice, the device is:
"A powered surgical instrument for improvement in the appearance of cellulite is a prescription device that is used for the controlled release of subcutaneous tissue for improvement in the appearance of cellulite. The device consists of a cutting tool powered by a motor and a means for instrument guidance to control the areas of subcutaneous tissue cutting underneath the cellulite depressions or dimples."
Federal Register Notice