GUDID registration

[pavanamg]

Hi,

Can a manufacturer of medical device with the 510(k) submission without approval register in GUDID ? or is it done once the manufacturer receives the 510(k) approval ?

Thanks

 

[IVDRegs01]

GUDID is for traceability once the device hits the market. Therefore, it would be expected that once your device is 510(k) cleared (not approved - FDA only approve PMAs and IDEs when it comes to medical devices - be careful with your marketing!), you would register on GUDID prior to making a sale.

Hopefully this helps

 

[EmiliaBedelia]

From a technological perspective it is not possible to update GUDID until you have received clearance.
You cannot register in GUDID until you have a medical device listing number. You cannot register and list for that device until you have clearance and the 510k is updated in DRLM. The GUDID database has multiple checks against other FDA systems so it will not permit you to submit with incorrect data.

 

[Mga_MD]

Only maanufacturets can update data to guidid? Or us agents/reg consultants as well?