CytoSorbents Corporation (CTSO)

[Murph1953]

21 CFR Part 820 and ISO 13485 compliant Quality Management Systems (QMS) for medical device and IVD manufacturers

The amount of time needed to comply with 21 CFR Part 820 can vary widely depending on how many facilities you have, the complexity of your manufacturing process, and whether there is someone in the company dedicated to quality management with the full support of management. Over the years our experience has shown that most medical device and IVD manufacturers are able to implement a QSR compliant QMS in three to seven months.
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I assume, if not already, soon they'll reclassify to 870.4260.
The gastro' category makes no sense, since REFRESH deals with cardio'.

How long will that take?

See subpart E
§ 870.4260 - Cardiopulmonary bypass arterial line blood filter.
§ 870.4280 - Cardiopulmonary prebypass filter.


https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=870

from here
https://google2.fda.gov/search?q=870.4280&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&requiredfields=-archive%3AYes&output=xml_no_dtd&getfields=*

I typed the # code in upper right
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=1865