Initial Registration of an Establishment with FDA

E

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!
 
M

MIREGMGR

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.

It's been 36 years since my current employer registered so I haven't spent much time lately focused on new-registration issues. Given that caveat, I'm not aware of a 30-day-delay rule. My understanding would be opposite, i.e. once you're registered (and you conform to the other applicable rules, i.e. 21CFR 820 etc.), you may market any exempt device immediately, and any non-exempt device as soon as it is cleared for marketability by FDA.

The FDA's rules and guidances are sometimes considered to be complicated, but in fact they're all pretty each to keep sorted out. Everything has a title and a website address. Perhaps the source of the 30-day-delay information could provide you with a reference as to where they think that rule is located--?
 
M

MIREGMGR

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.

A further comment: you mention import/export. You may want to wait to attempt either import or export until after you are registered and have listed. Depending on circumstances, there's a good chance that Customs and Border Protection will ask for registration and listing information before clearing a medical device importation. With regard to exporting, you will be unable to apply for a Certificate to Foreign Government until you are registered and have listed. You also may have problems with the receiving nation's border people if you cannot provide FDA registration and listing information.
 
E

ElmerF

Hi Everyone,

Thanks for your comments. My plan is to register as soon as I get SE letter and before we begin to ship product, so it sounds like that is acceptable.

Thanks again
 
Top Bottom