A premarket notification 510(k) is made to demonstrate substantial equivalence.
An FDA clearance grants permission for a medical device to be marketed in the U.S.
Two different animals.
When a company’s FDA - cleared product patent expires, another entity cannot use the existing clearance(s) by simply replicating the product. They must submit either a (510(k) process, Premarket Approval (PMA), De Novo classification, or other regulatory pathway via new application(s) for FDA clearance that complies with current regulations and guidelines. FDA makes that determination.
Good luck with a Chinese manufacturer filing for a 501k, if that is even the path granted by the FDA. Politics. Remember the time ActiPatch was cleared for females only given “sufficient” safety and efficacy vs males until that crap got straightened out? Or what filing process BIEL had to use until that got straightened out too?
Good luck with any Chinese company or any Country making a knock-off and trying to sell it in the USA. Especially in this political environment.
BIEL has 5 FDA clearances inclusive of musculoskeletal.
“No proof of efficacy or safety needed, just proof of substantial equivalence, and that would be a slam dunk because they are buying the device from that same Chinese manufacturer who is already registered with the FDA.”
No, BIEL and their product has 5 Clearances that demonstrates safety and efficacy and are “registered” with the FDA, not “registered via the Chinese assembler.
A US company having their product made in China is quite different from a Chinese company making a knockoff-off to sell here.
Yeah, politics.
Now, an entity merging with Biel would be interesting though. My guess is that a USA company would be a “neater” process.
imo
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