Some hypothetical situations regarding FDA registration:

ScottK

Not out of the crisis
Staff member
Super Moderator
#1
How would you smart folks answer these questions...


1) a business has two units in different facilities. Main unit is a manufacturer of class 1 devises and is registered. Secondary unit does metal finishing only (anodizing, plating, passivating). Does the secondary unit need to be registered as under a separate number? The secondary unit does not sell services directly to medical device customers.

2) A company makes a check valve that will go into a class II medical device. Does this company need to register as a medical device manufacturer?

3) A company that is registered with the FDA has a machine shop at another site that makes components that go into its class I device - does the machine shop need to be registered separately. The machine shop does not sell directly to medical device customers - all parts go through the parent company.

4) The above machine shop wants to sub some work to another machine shop that is part of a medical device company but is not registered separately as they maintain that they mack components for medical devices. Is this correct under the new rules?

Thanks!
 
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M

MIREGMGR

#2
1. No.

2. Not for that activity. It's a component.

3. No.

4. Sure.

The "new rules" pertain to Listing of Contract Manufacturing activities. Contract Manufacturing by definition involves finished devices...either fabrication of the finished device for another party, or provision of critical services (i.e. sterilization, sterile barrier packaging, etc.) for an otherwise-finished device. The rules have not changed for component makers.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#3
1. No.

2. Not for that activity. It's a component.

3. No.

4. Sure.

The "new rules" pertain to Listing of Contract Manufacturing activities. Contract Manufacturing by definition involves finished devices...either fabrication of the finished device for another party, or provision of critical services (i.e. sterilization, sterile barrier packaging, etc.) for an otherwise-finished device. The rules have not changed for component makers.
Thanks. I knew you'd be the first to jump in. :)
 
J

JohnM

#4
What about a foreign contract manufacturer that makes a Class II finished device for another foreign company that then packages the device and exports it to the US? Do both have to register?
 
M

MIREGMGR

#5
What about a foreign contract manufacturer that makes a Class II finished device (...)
They're a Contract Manufacturer, so they have to be Registered and they have to List.

(...) for another foreign company that then packages the device and exports it to the US?
The implication is that the second company is a Specification Provider, directing the Contract Manufacturer's activity. As such, they have to be Registered and have to List.

The fact that they do packaging is irrelevant, since Specification Provider already creates a Registration and Listing obligation.
 
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