Impact of Regulations on Biopolymers for Medical Applications

Over the last several decades, the fundamental science of biopolymers has advanced quickly and the growth of the biopolymer industry today has mainly developed via the wide spectrum of innovative applications now possible. Although the progress is affected largely by developments and innovations that occur at the academic level and in corporate sectors, Federal Government policies and regulations (either directly or indirectly) are pivotal in steering the overall development of the biopolymers market.

The regulatory system that governs the approval process for the use of biopolymers for medical applications in the US, is the Food and Drug Administration (FDA). It is a regulatory agency that is accountable for approving the safety of a large variety of products such as foods, cosmetics, drugs, medical devices, biological products, and radiological products.

Biopolymers are a class of compounds with versatile applications that impact virtually every industrial and market sector. Hence, it is imperative to evaluate the safety of biopolymers in each of these sectors, before they are made available for commercial purposes. However, the principle biopolymer applications that would be affected by FDA guidelines are the medical devices and drug delivery applications. This section focuses on the impact of the United States regulations, which are imperative for the growth and success of the biopolymer industry.