Replies to post #14338 on CytoSorbents Corporation (CTSO)

[biotech48]

eskay1954, you are incorrect about there being no fast track status for a medical device.

Expedited Access Pathway Program
"The FDA recently published draft guidance on the Breakthrough Devices program. You can submit your comments on the draft guidance, which describes the policies that the agency intends to use to implement the program, by December 26, 2017.

On December 13, 2016, the Breakthrough Devices provisions were added to the Food, Drug, and Cosmetic Act through section 3051 of the 21st Century Cures Act. This program is intended to help patients have more timely access to devices and breakthrough technologies that provide for more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases, for which no approved or cleared treatment exists or that offer significant advantages over existing approved or cleared alternatives.

The Breakthrough Devices Program expands upon the Expedited Access Pathways (EAP) program by making future 510(k)s eligible as well as Premarket Approval applications (PMA) and De Novo device submissions. All participants previously granted EAP designation will have designation as Breakthrough Devices; no separate action is necessary.

For any questions about the Breakthrough Devices program or EAP, please contact [e-mail].

https://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/ucm441467.htm