Significance of Category Classification of Novel Medical Products Originated from Japanese Academic Researches with Regards to Its Industrialization

Abstract

This communication to chief editor discussed category classification process of medical products originated from Japanese academic researches, showing that of authors’ product for example. US guideline in 2017, “Classification of Products as Drugs and Devices & Additional Products. Classification Issues: Guidance for Industry and FDA Staff. Final Guidance”, was refereed and key provisions for device definition were introduced. In US, medical products were defined as device when primary intended purpose of the product was not achieved through chemical action. Examples of FDA’s device definition of two kinds of heat generating nanoparticles were shown as gold nanoparticles illustrated in the guideline and magnetite cationic lipid composite particles (formerly named magnetite cationic liposomes) originated from Japanese academic research. Concerning category classification process in Japan, necessity of detailed discussion between academia and administrative agency was issued in order to facilitate its technology transfer to Japanese industry.