Medical device mixtures: A manufacturer's viewpoint

摘要

In our 3rd quarter 2016 issue, we visited medical gases from the viewpoint of sales potential by discussing the end-use applications our gases served. In this article, I want to address medical gases, and more specifically medical device mixtures from the manufacturers viewpoint. This is important based on the degree of difficulty, the base of knowledge required, and the investment in technology required to manufacture this line of precision gas mixtures consistently to specification. The requirements as related to Food and Drug Administration (FDA) registration and listing are not that different from drug requirements and are equally enforceable. Initial registration identifies the physical location producing the drug or device, and must be completed within five days of beginning operations. Subsequent annual registrations are required annually. Listings pertain to the actual products that will be offered by the registered location (a place of business under one management and one general physical location).