Re: New Establishment Registration and Device Listing Rule
We haven't seen the new DLRM site structure yet, but my impression is that now every player in device making will have to report as a part of their Listing, all of the other Registration-subject players that are involved.
So, I as a Specification Developer as a part of my Listing for Device X will have to enter the Registration numbers of the Contract Manufacturer I use, and the Sterilization Contractor that I use.
I as the Manufacturer or Specification Developer will have to List first.
Then once I've Listed, the Contract Manufacturer (either in USA or overseas, whether distributing or not) will have to List the same device, entering the Registration number of their customer for that device (me). Ditto for the Sterilization Contractor that I use. Their Listings will have to point to mine, already entered.
A sizeable, compliant Contract Manufacturer or Sterilization Contractor, with a lot at risk if they're non-compliant, won't want to fail to complete a Listing. So, they'll notify their customers that they have to be given the necessary info with which to List.
I'm pretty sure FDA will provide a way for that kind of player to report that they have activity to List, but they can't because the Manufacturer has to go first and apparently hasn't done so.
I think the specific point of these changes is to enable FDA to easily identify, and take enforcement action against, players in these activity chains who are ducking the requirements and the FDA hasn't had the ability to find under the past system. Now it'll be harder to be invisible.
I doubt if there are many multi-customer Contract Manufacturers or Contract Sterilizers that aren't aware of this change. I think FDA's focus is on Manufacturers and Specification Providers.