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!
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!