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ElmerF
The FDA website provides the following instruction for companies making a first time registration
Initial Registration
Submit registration and /or listing information within 30 days of an establishment beginning an activity or putting a device into commercial distribution. Foreign establishments must register before exporting products to the United States and domestic importers must register before importing products. Reminder that if your device requires premarket notification clearance or approval, you will have to wait until your premarket submission [510(k), PMA, etc.] is cleared or approved to register your establishment and list the device.
It seems clear that we must wait until our first product is given substantial equivalence for 510K. Just would like a clarification on the 30 days. I had understood from another manufacturer that you cannot sell product for 30 days after registration is complete. This seems to be saying that you could sell product immediately upon getting SE notification but must complete registration at the latest 30 days after importing/exporting. Can anyone provide some clarity. Is there somewhere else on the fda website that provides more detail?
Thanks!
Initial Registration
Submit registration and /or listing information within 30 days of an establishment beginning an activity or putting a device into commercial distribution. Foreign establishments must register before exporting products to the United States and domestic importers must register before importing products. Reminder that if your device requires premarket notification clearance or approval, you will have to wait until your premarket submission [510(k), PMA, etc.] is cleared or approved to register your establishment and list the device.
It seems clear that we must wait until our first product is given substantial equivalence for 510K. Just would like a clarification on the 30 days. I had understood from another manufacturer that you cannot sell product for 30 days after registration is complete. This seems to be saying that you could sell product immediately upon getting SE notification but must complete registration at the latest 30 days after importing/exporting. Can anyone provide some clarity. Is there somewhere else on the fda website that provides more detail?
Thanks!