Re: Finding Medical Device Listing Numbers on the FDA site
Yes, since my earlier post the FDA has introduced the PREDICT import-information system. In many cases, FDA border offices want screenshots of DRLM listing pages...not just the textual information...with the PREDICT filing.
That essentially makes it impossible to import medical devices into the US using older information that the importer might have on file, without the regulatorily responsible Manufacturer's current participation.
I've made one or two other posts here recently with more specific information on how PREDICT actually works, based on our interactions with FDA Maryland, FDA Dallas and the El Paso border office, and several large kit packers.