New Establishment Registration and Device Listing Rule - August 2012

M

MIREGMGR

#11
Re: New Establishment Registration and Device Listing Rule

I spoke with FDA today and learned two bits of information:

1. No guidance will be forthcoming before October 1, when the program commences.

(As a side point, I think a post earlier in the thread says that this is due October 1...not so, October 1 is the earliest you can Register and List for FDA year 2013, with December 31 being the last day for such activity before penalties and regulatory actions could apply.)

2. Outside-US Contract Manufacturers always have been required to Register and List. Under the new system, outside-US sterilization and packaging subcontractors also will be required to Register and List.
 
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A

ariannas

#14
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?
This may not count as official guidance, but I did pick up the attached presentation from the REDI conference that I attended yesterday. It covers the FDASIA changes and also gets into the two systems (one for payment and the other for the actual listing) that have to be used to register.

The file name is my own invention, not the FDA's :)
 

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M

MIREGMGR

#15
My analysis of the presentation above is that it's a survey of the basics, and doesn't provide any information that advanced FDA regulatory folks wouldn't already have known from the prior rules and practices plus the original disclosure of the 2013 plans.

It's useful to know that FDA hasn't sorted this stuff out to the point where a presentation like this wouldn't contain some new details of the sort that Michael Malis asks about.
 

Sam Lazzara

Trusted Information Resource
#16
What if you are an FDA registered Manufacturer and your Contract Sterilizer is FDA registered but does not specifically list your devices that they process? How concerned would you be about this?
 

amjadrana

Involved - Posts
#17
I have another question related to the same thread. What are the requirements to register for a Canadian distributor, who imports the class one surgical instruments from a German manufacturer into Canada and then sells these in US? Does the German manufacturer needs to register or does the Canadian Importer and distributor of German products needs to register with FDA to sell these products into the US.

What are the registration requirements if the products are class II. If the German manufacturer applies and gets the 510(k), does the Canadian importer and distributor needs to register with FDA additionally?

Thanks
 
M

MIREGMGR

#18
What if you are an FDA registered Manufacturer and your Contract Sterilizer is FDA registered but does not specifically list your devices that they process? How concerned would you be about this?
What do you mean by "specifically list"?

An example to illustrate the point I'm after: my interpretation is that it's permissible, when the number of devices involved is sufficiently large and their nature is closely related, to list them as a family, without itemizing each family member. This however (in my interpretation) requires that the family listing have a sufficient description that a family member can be unambiguously recognized and identified by FDA upon their receipt of a field report or other information.

So if your contract sterilizer Lists your products as a family in this manner, that might be OK.

Of course, if they don't List your products at all, that would be bad.

If they do have a Listing for the Product Code applicable to your products, but they just state "X devices by Y company" or somesuch as a Proprietary Name entry under that Listing with no particular possibility that your actual product label information could be related to that Listing of theirs, then my take would be that FDA could have a problem with that at some hypothetical future point.

I wouldn't be hugely concerned at this point because I think it would be their hand that would be slapped, not yours.
 
M

MIREGMGR

#19
What are the requirements to register for a Canadian distributor, who imports the class one surgical instruments from a German manufacturer into Canada and then sells these in US? Does the German manufacturer needs to register or does the Canadian Importer and distributor of German products needs to register with FDA to sell these products into the US.

What are the registration requirements if the products are class II. If the German manufacturer applies and gets the 510(k), does the Canadian importer and distributor needs to register with FDA additionally?
The German company is a Manufacturer, must Register and List, and has 510(k) responsibility if applicable. The Canadian company as described here, per http://www.fda.gov/MedicalDevices/D...urDevice/RegistrationandListing/ucm053165.htm, appears to be a Foreign Exporter and as such would be required to Register and List.
 

Sam Lazzara

Trusted Information Resource
#20
Thank you Miregmgr. By "specifically list" I was thinking of a situation where the Manufacturer's device classification(s) were clearly not represented among the devices listed by the CS.
 
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