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Hi All,
We are a registered initial distributor in the U.S. of FDA Class I devices. We have a Class I component (the main device) currently marketed and sold that requires a disposable element (also FDA Class I). The disposable element is currently being supplied 'free of charge'.
1.Does this disposable element require any type of control and does the free of charge policy violate any regulation?
2.Is there any FDA liability if it is not being sold but still distributed with the main device?
We are a registered initial distributor in the U.S. of FDA Class I devices. We have a Class I component (the main device) currently marketed and sold that requires a disposable element (also FDA Class I). The disposable element is currently being supplied 'free of charge'.
1.Does this disposable element require any type of control and does the free of charge policy violate any regulation?
2.Is there any FDA liability if it is not being sold but still distributed with the main device?