Devices and Personal Sound Amplification Products , issued on November 7, 2013. Such updated and finalized guidance shall clarify which products, on the basis of claims or other marketing, advertising, or labeling material, meet the definition of a device in section 201 of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 321 ) and which products meet the definition of a personal sound amplification product, as set forth in such guidance.