“That’s one small step for man, one giant leap for mankind.”
When Neil Armstrong spoke these now-famous words as he stepped off Apollo 11’s lunar excursion module and onto the moon on July 21, 1969, it was both a small physical step, like the many steps each of us takes every day, and a giant figurative leap for mankind to walk on another world for the first time. Similarly, the approval processes for medical devices subject to review in the United States through the US Food and Drug Administration (FDA) can be characterized as many “small steps” via the simple premarket notification, or 510(k) process, and relatively few “giant leaps” via the rigorous and expensive premarket approval (PMA) process. Overwhelmingly, most reviewable medical devices are evaluated and approved by the far less-stringent 510(k) process because they represent either Class I (low risk) or Class II devices (intermediate risk, such as electrocardiography machines).1 New Class III devices (high risk, such as cardiac pacemakers) require approval through the much more stringent PMA process, which requires formal evaluation of safety and efficacy, often in the form of expensive randomized trials.2 If a Class III devices is “substantially equivalent” in function and use to an already approved device, submission of supplementary materials to an existing PMA may suffice.