Late to the annual FDA device facility registration

[zateek]

Hi all,
I have been helping a very small medical device company that has its facility registered as the specifications developer and manufacturer for a medical device under the US FDA. They are dealing with some serious budget issues and fear that they may not be able to make the payment for the annual registration that is due by the end of the year. Does anybody have any insight on what happens if the registration is late?

 

[indubioush]

Are you selling product?

 

[Ed Panek]

Chances are nothing would happen but the FDA may have an issue if you have previously sold product and received complaints on those products. You pay fees to help cover costs of the FDA operations. If you fail to pay the fee and FDA wants to see your complaint files you might get into trouble since you are not paying the fee.

 

[zateek]

Chances are nothing would happen but the FDA may have an issue if you have previously sold product and received complaints on those products. You pay fees to help cover costs of the FDA operations. If you fail to pay the fee and FDA wants to see your complaint files you might get into trouble since you are not paying the fee.

Thank you! They are selling the devices currently. I don't believe any complaints have been received in the past.

I ended up reaching out to CDRH and they said that the current registration will not expire until the end of January. They will be sending reminders to re-register until then and if we still fail to do so, the registration will eventually expire by mid-February. If it does expire, we will simply need to make the payment and reactive the registration to resume the sales.