Questions about FDA registration and 510k application

E

eliza2008

#1
Dear All,
Now I want to apply 510k for our products, but our company have not registered from FDA yet, so I want to know the sequence of apply 510k and register from FDA. Because it seems from FDA website we can apply 510k at first, and then register and do product listing.
any answer would be appreciate!
:thanx:
 
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M

MIREGMGR

#2
1. Register. I'm pretty sure it's not possible to pay the User Fee for review of a 510(k), necessary to submit it, until you are Registered. Certainly the FDA wants you Registered before they will interact with you as a medical device company.

2. If you have existing 510(k)-exempt devices that you intend to market within FDA jurisdiction, List them.

(Steps 1 and 2 can be completed in a few hours, aside from arrangements for payment.)

3. File for your 510(k).
 
E

eliza2008

#3
thank you MIREGMGR. So we have to register and list our devices at first, then FDA will review our files on 510k, that's right sequence.:thanx:
 
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