In October 2010, the FDA published the initiative “Advancing Regulatory Science for Public Health”, which has meaningful goals for developing new tools, standards and approaches to assess the safety, efficacy, quality and performance of FDA-regulatory products. So, why am I struggling with the FDA considering regulatory a science?
There are three FDA regulatory classes of medical devices: Class I, Class II and Class III. The classifications are assigned by the risk the medical device presents to the patient and the level of FDA control. The lowest category of devices (Class I) provides the least burdensome FDA pathway and control, and applies to non-life sustaining tools and hand-held instruments. Read More