Clinica 100: What lies ahead for US device regulation
This article was originally published in Clinica
Executive Summary
The jury is still out as to how the US regulatory system is going to evolve in the long term, but change it will. As the FDA gathers feedback on the IOM's damning report on the 510(k) system and the recommended changes, Glenn Neuman, director of scientific affairs at New World Regulatory Solutions*, details what to expect in the short term