Is it right that as long as the applicant's company meets QSR and manufacturing site resides in US, they can apply for CTFG for any medical device?
red_wood,
1) The company has to be registered with the FDA and passed an FDA inspection. I agree with MIREGMGR that the inspection date is irrelevant (but is necessary in the application process) as long as no outstanding issues were found.
2) The manufacturing site does not have to reside in the US but I think the applicant has to be the PMA holder.
Q