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FDA Final Guidance On Drug/Device Classifications Misses The Mark, Attorneys Say

 
• By Michael Cipriano

The final guidance adds some requested clarifications, but does not appear to address the US agency's tendency to designate products as drugs over devices, industry attorneys argue.

Arrows miss target

US FDA's final guidance on the classification of products as drugs or devices contains some useful clarifications for industry, but experts remain concerned that the guidance contains too much room for the agency to continue its tendency of classifying products under the more heavily-regulated drug pathway.

FDA published the guidance, "Classification of Products as Drugs and Devices & Additional Product Classification Issues," on Sept. 26. It finalizes both the June 2011 draft version and a separate June 2011 draft guidance titled ‘‘Interpretation of the Term ’Chemical Action’ in the Definition of Device under Section 201(h) of the Federal Food, Drug, and Cosmetic Act

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