FDA Issues Draft Guidances on Drug & Device Classification, Etc.
The Food and Drug Administration is announcing the availability of two related draft guidances for industry and FDA staff entitled "Draft Guidance for Industry and FDA Staff: Classification of Products as Drugs and Devices and Additional Product Classification Issues" and…
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"Draft Guidance for Industry and FDA Staff: Interpretation of the Term 'Chemical Action' in the Definition of Device Under Section 201(h) of the Federal Food, Drug, and Cosmetic Act." To be considered for the final versions of these guidances, comments are due by September 19, 2011.