How do I inform FDA on discontinuation of 510(K) device ?

A

AJayC

#1
The company I work for has discontinued manufacturer of a device with a 510K clearance.
What are therequirements for notifiying the FDA?

We will be importing the device - instead of manufacturing it.
The device will be sold shrink wrapped or boxed with a "Manufactured for" label;
the intended use will not change.
 
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A

ascherp

#2
Hello April,

Is the device you are now importing being manufactured for you according to your specifications, i.e. is it identical to your cleared device?
 
M

MIREGMGR

#3
The company I work for has discontinued manufacturer of a device with a 510K clearance. What are the requirements for notifiying the FDA?
There are none for the 510(k) per se. If you were discontinuing being the responsible party for the device, you no longer would List it as its Manufacturer, and if it was your only marketed product you would no longer Register as a Manufacturer...but the former change is unclear from your comment, and the latter change will need to be considered in light of the new Registration requirements for 2013. You might still have to Register as a Specification Provider, and/or as the Initial Importer.

We will be importing the device - instead of manufacturing it. The device will be sold shrink wrapped or boxed with a "Manufactured for" label;
the intended use will not change.
Is the device you are now importing being manufactured for you according to your specifications, i.e. is it identical to your cleared device?
"Manufactured For" is (most often) FDA-label-code for you being a Distributor, and the maker being the Manufacturer. In order for that to be the case, they must be Registered as the Manufacturer, they must List the product, and they must have a 510(k) for the product. You of course could transfer your 510(k) to them via letter-of-agreement or contract. FDA has no role in such transfers.

If the offshore maker will not be Registered as the Manufacturer, you might remain responsible for the product as its Specification Provider. Then the offshore maker would have to be Registered as the Contract Manufacturer, and would have to List the product on that basis. You would remain the holder of the 510(k).

It also would be possible for the offshore maker to be a non-medical-device company and provide you with a product that is incomplete in some respect as a Component per 21CFR807.65(a). You then would remain the responsible Manufacturer for the device that you would legally create and perhaps physically finish, and you would hold the 510(k). You also would be responsible for all aspects of your supplier's operations.

Whatever other arrangements are in place, it sounds as if you will be the Initial Importer, so you will have to Register on that basis--possibly in addition to being the responsible Manufacturer or the Specification Provider.

Note BTW in regard to your 510(k) that if it included declaration of particular and/or validated material sources/grades and manufacturing processes, a Special 510(k) might be required to clear the materials and processes to be used by the new maker.
 
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A

AJayC

#4
The off-shore device manufacturer is registered with the FDA.
We do not specify how the product is manufactured, however, we did validated that the product is identical to the what we were manufacturing.
 
M

MIREGMGR

#5
If the maker is Registered and the product is Listed by them as a Manufacturer, and they are not acting as a Contract Manufacturer for you, then you will no longer List the product as a Manufacturer or Specification Provider and they will have to be the 510(k) holder. Under the upcoming 2013 rules, you however will have to Register as the Initial Importer.

Your validation that the product is identical is irrelevant.
 
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