Replies to post #23254 on CytoSorbents Corporation (CTSO)

[techxen]

The accelerated programs for drugs has diverged from devices and is somewhat different.
Here is the programs for drugs: https://www.fda.gov/patients/learn-about-drug-and-device-approvals/fast-track-breakthrough-therapy-accelerated-approval-priority-review)


For medical devices the Breakthrough Devices designation which was granted for the removal of ticagrelor supersedes what used to be Expanded Access (EAP), which the company tried for back in 2016 for sepsis but abandoned. This Breakthrough Devices approval also supersedes the Priority Review Program, so in essence the company is already in priority review. The next step is to determine what the approval path will be e.g. 501k De Novo or what.


"The Breakthrough Devices Program also supersedes the Priority Review Program, which implemented statutory criteria for granting priority review to premarket submissions for medical devices and included standard procedures to achieve an efficient priority review process. However, consistent with Section 515B of the FD&C Act, devices designated as Breakthrough Devices will receive prioritized review (Section II.F)."

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/breakthrough-devices-program