With continuous innovation occurring in the medical field, it is imperative for federal regulations to keep pace. Today, most new and follow-on devices experience a lengthy regulatory process, especially when compared with their drug counterparts. But the federal government is trying to address this and other concerns through new proposed legislation. Here is what we know thus far.
Companies that are developing medical technologies pose incredible opportunities for high growth and significant economic impact (job creation, revenue generation, etc.); however, they also experience the need for significant capital as well as a lengthier time to commercialize their innovations. This is due, in large part, to FDA and other forms of regulation. Below is an overview of important regulatory principles: