Hello,
We're launching a new IVD in the US market which is prescription diagnostic test. I wounder if we need to have pharma code or anything that will identify the test in the prescription, similar to NDC in drugs.
Any ideas?
Thanks!
Hello,
We're launching a new IVD in the US market which is prescription diagnostic test. I wounder if we need to have pharma code or anything that will identify the test in the prescription, similar to NDC in drugs.
Any ideas?
Thanks!
For the US Market, all the IVDs fall under Medical Device and not Pharma. You can refer to this FDA section which gives all the details pertaining to In Vitro Diagnostic products (IVD) - Overview of IVD Regulation
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