Replies to post #8526 on CytoSorbents Corporation (CTSO)

[techxen]

The FDA has a formal Reclassification process: "As experience and knowledge about a device increase, the original classification of a device can be changed through reclassification.

Reclassification Process Described in Section 513(e) of the FD&C Act

Under section 513(e) of the FD&C Act, the FDA may, on its own initiative or in response to a petition from an interested person, reclassify a device type based on “new information.” The new information received about a device must be publicly available “valid scientific evidence,” as defined in section 513(a)(3) of the FD&C Act and 21 CFR 860.7(c)(2).
If the FDA or a petitioner proposes that the device type be reclassified into a lower class (from Class III to Class II, Class II to Class I, or Class III to Class I), the FDA or the petitioner must identify sufficient valid scientific evidence to support a determination by the FDA that the safety and effectiveness of that device type can be assured through the less stringent regulatory controls of the lower class."

More about this reclassification process can be found here:

https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ucm378724.htm

What was very interesting on this site is the Summary of Medical Devices Reclassified Since 2013. There have been four (4) sorbent hemoperfusion systems (CDR 876.5870 - FLD) reclassified down from a Class III to Class II devices, with a link to their detailed ruling so you can see details of what those devices were.