|
Trends in FDA Approval of Breakthrough Devices
(Friday, July 14, 2023) Since its inception about 5 years ago, FDA’s Breakthrough Device Program has been involved in 67 new device approvals out of about 700 devices designated as breakthrough devices. A review of the devices designated as breakthrough and approved via this pathway indicates a few interesting trends for this program such the indications for which FDA’s tends to grant this designation more often, the regulatory pathway used to approve such devices, and the time to market authorization. The Breakthrough Device program is intended to expedite development of devices that provide a more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions. In addition, the device must meet “one” of the conditions that (a) the device contains breakthrough technology, (b) has no approved or cleared alternatives, (c) offers significant advantages over existing approved or cleared alternatives, or d) that the device availability is in the best interest of patients. The Breakthrough Device program replaced the Expedited Approval Pathway and the Priority Review for devices. On the surface, these conditions appear quite simple to meet, for example, it would seem relatively easy to show that “the device availability is in the best interest of patients”. However, the kind of devices designated and approved by the FDA under this program show a trend to FDA’s interpretation of these conditions. More than half of the devices (411 out of 798) that were designated Breakthrough Devices were for three out of 20 indications: cardiovascular, neurology, and orthopedic. Most of the devices approved under this program also were for these indications. Regarding the preferred regulatory pathway, surprisingly more than 70% of the Breakthrough Devices were approved via the 510k pathway, 47 out of 67. Among the 510k devices, there were similar number of devices cleared through the traditional 510k (26) and the De Novo pathway (21). Another way to look at the info could that 41 of the 67 devices were bonafide new devices approved either through the PMA or De Novo 510k pathway, while 26 were devises that were substantially equivalent to a predicate device but could still meet one of the conditions for designation under this program. This provides the context for strategic planning. A device could get Breakthrough Device designation even if it has predicates, and it could still be cleared via the 510k pathway. If a device is cleared via the De Novo pathway, it opens the door for subsequent devices to be cleared via the traditional 510k pathway using the first approved device as a predicate. Devices for cardiovascular, neurological, and orthopedic conditions have a better probability of getting this designation although other indications have also been successful. Getting a Breakthrough Device Designation is an important milestone for any device. It is important for developers to understand the nuances of the program to better strategize. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: mkumar@fdamap.com Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
|
|
|
