New Establishment Registration and Device Listing Rule - August 2012

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Ronen E

Problem Solver
Staff member
Moderator
#2
Re: New Establishment Registration and Device Listing Rule

A full overview of this and other changes:

http :// www .fda.gov/MedicalDevices/ResourcesforYou/Industry/ucm314844.htm - OBSOLETE BROKEN 404 LINK(s) UNLINKED
 
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M

MIREGMGR

#3
Re: New Establishment Registration and Device Listing Rule

This will be a major change for the industry, with a potentially very large amount of new administrative work for contract manufacturers and contract sterilizers, in particular.

My understanding is, the goal is to catch unregistered/non-listing Manufacturers/Specification Providers by database analysis, when the contract manufacturers, contract sterilizers and initial importers with which they do business try to list the involved devices but can't because the responsible Manufacturer/Specification Provider hasn't themselves listed the same devices.
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Re: New Establishment Registration and Device Listing Rule

A detailed estimate for the additional burden (both in $ and time) is included in the FR publication (link on my opening post). Indeed a large amount.
 

Chrisx

Involved In Discussions
#5
Re: New Establishment Registration and Device Listing Rule

Is there any expectation that I enforce this with my suppliers. Does anyone think that this should be added to supplier agreements. Is FDA likely to take enforcement action against a manufacturer because their contract manufacturer or contract sterilizer did not register or list? I am guessing many of them are not aware of this change.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
Re: New Establishment Registration and Device Listing Rule

I don't think the FDA expects that you enforce this with your suppliers; however it may be advisable to add it to your supplier agreements, because although FDA probably won't take enforcement action against the manufacturer, they probably would do so against their contract manufacturer or contract sterilizer if they did not register or list. The net effect could be an action against the manufacturer - disruption of supply etc. I also assume the FDA "counts" on manufacturers to help them spread the word to CM and CS who are not aware of this change.
 
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M

MIREGMGR

#7
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.
 
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Michael Malis

Quite Involved in Discussions
#8
Re: New Establishment Registration and Device Listing Rule

There are still a lot of questions around this issue.
Does anyone know if FDA plans to provide additional guidance?
 
M

MIREGMGR

#9
Re: New Establishment Registration and Device Listing Rule

There's no mention of a forthcoming guidance or a full explication of the revised rules in the advisory letter, even though that letter describes the information it contains as a summary.

It however does say:

If you have any questions or need assistance regarding registration and listing, please contact the Centers for Devices and Radiological Health (CDRH) Registration and Listing Helpdesk by email at [email protected].
 

Ronen E

Problem Solver
Staff member
Moderator
#10
Re: New Establishment Registration and Device Listing Rule

Maybe some additional information / clarifications can be found here:

http :// www .fda .gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MDUFAIII/ucm315987.htm - OBSOLETE BROKEN 404 LINK(s) UNLINKED

Either way, the FR publication which I linked to has a preceding discussion which may shed some light.
 
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