A History of US Medical Device Regulation and Current Regulatory Framework.

» The Food and Drug Administration (FDA) was created in the wake of public outcry generated by Upton Sinclair's The Jungle. The FDA gained further regulatory authority following successive public health setbacks in the 20th century. » A full review for a new device is referred to as a premarket approval (PMA), while an application for a device based on a predicate is referred to as a premarket notification (PMN) better known as a 510k. » Both for PMNs and PMAs the costs and timelines typically far exceed the statutory limits imposed by congress, running into years of review and many millions of dollars. » Real-world data (RWD) can now be used to generate evidence for use in regulatory applications; this change will hopefully reduce the cost and time-to-market for new medical devices. » RWD has significant limitations such as bias, confounding, missing data, and privacy concerns that will require the FDA to take a fit-to-purpose approach for applications using RWD.