US FDA explains info needed for formal product classification requests
This article was originally published in SRA
Executive Summary
The US Food and Drug Administration has issued revised guidance explaining the type of information that companies should submit when seeking a formal determination of the regulatory identity of their product as a drug, device, biological or combination product1,2. The company's request for designation (RFD) results in the FDA assigning the product's pre-market review responsibility based on the product's "primary mode of action".
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