Importing a custom component for our medical device

maxoverclock

Registered
We are developing a Class II medical device and are going through 510K process. Our IVD device includes a sanitary pad that has been contract manufactured to our specification that will never be sold or marketed alone. The custom broker is unsure how to handle since the harmonized code is the same as the commercial product that is regulated and sold commercially and normally requires FDA clearances. We have assumed that since this pad is just a component to our medical device purchased in bulk that it is not considered a medical device and instead treated as a component.

Is there an issue here? I don't see how this component could be regulated as a medical device since it would never, in our case, go through a individual approval process. Are we correct to view this component as exempt from FDA for the purpose of importation?
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
If I sell a ruler its just a ruler. If I claim its for use in surgery to determine incision points thats a medical claim.
 
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