Requirements for Registering and Listing with the FDA

[RCW]

Looking for somebody to shed some light here....

After reviewing the "Who Must Register and List" table at the FDA website, my company would fall into the "Contract manufacturer who does NOT commercially distributes for the specifications developer." According to the table, my company does not have to register or list.

Now we have received a FAQ list from the FDA which for "Who is required to list their devices?" says ".....In addition, contract manufacturers and contract sterilizers (......) must also now list at the time of their annual registration." It doesn't differentiate between commercial distributors or non-distributors.

Anybody have any input from their own recent experience?

Also, it looks like the FDA is charging now to register every year (an incremental scale at that too). That's one reason I don't want to register or list if I don't have to.

[Ajit Basrur]

Originally Posted by RCW

Looking for somebody to shed some light here....

After reviewing the "Who Must Register and List" table at the FDA website, my company would fall into the "Contract manufacturer who does NOT commercially distributes for the specifications developer." According to the table, my company does not have to register or list.

Now we have received a FAQ list from the FDA which for "Who is required to list their devices?" says ".....In addition, contract manufacturers and contract sterilizers (......) must also now list at the time of their annual registration." It doesn't differentiate between commercial distributors or non-distributors.

Anybody have any input from their own recent experience?

Also, it looks like the FDA is charging now to register every year (an incremental scale at that too). That's one reason I don't want to register or list if I don't have to.

According to http://www.fda.gov/cdrh/registration/whomust.html, if you are a "Contract manufacturer who does NOT commercially distributes device for the specifications developer", you NEEDNOT NEITHER REGISTER NOR LIST.

This list was last updated on Oct 2, 2007 so not sure of the FAQ list that you mentioned. Is that FAQ on the FDA website ?

[RCW]

Saw the list at the website linked to above. That's where I got the idea that I don't have to register or list.

Now I have a 6 page letter in my hand with the first page reading "Important Information On Medical Device User Fees For FY 2008". Four of the pages are FAQs and I see several places where it says the "In addition..." statement I posted earlier. That document says effective October 1, 2007.

What is a person to go by?

[Doug Tropf]

You can email your particulars to reglist@CDRH.fda.gov and get your answer.
We are a contract sterilizer and did register due to sending some of our
customers devices directly to the market for them.