On December 8, 2015, the U.S. Food & Drug Administration (“FDA”) cleared for marketing in the United States a cooling cap to reduce hair loss in breast cancer patients undergoing chemotherapy. Marketed under the name the DigniCap® Cooling System, the cooling cap is manufactured by Dignitana, a Swedish company making its first foray into the United States medical device market.
After multiple clinical studies and extensive use in overseas markets, the DigniCap® scalp cooling system is the only such device to have completed an FDA-cleared multi-center clinical trial and is cleared for use with treatment regimens associated with breast cancer. More information about the device may be found here.
The FDA cleared the DigniCap through the de novo process. The de novo process, a relatively new pathway, provides an alternate means of clearing novel devices of low to moderate risk. Initially, Dignitana submitted the device for Premarket Approval (“PMA”) to the FDA at the beginning of 2015. After a brief review, the FDA converted the PMA to the de novo regulatory pathway since the FDA did not consider the DigniCap System a high-risk device warranting a PMA.
Through the De Novo process, device sponsors are able to utilize a hybrid-type pathway for clearance by bringing low-risk devices to market in situations where they would not otherwise be able to utilize the more confined 510(k) pathway. In particular, where the 510(k) pathway is most-frequently used to clear new devices, it is only available to those new devices that have a clear predicate device or are substantially equivalent to another legally marketed device. Devices that do not otherwise have a predicate device available but are still lower-risk that would be appropriate to merit a PMA, now have a pathway via the de novo process. More information about the De Novo process can be found here and here.
Navigating the FDA’s web of regulations governing medical devices can be a daunting task. If you have any questions about FDA regulations or how they relate to the marketing of a medical device, please contact us at contact@sglawfl.com.