How the FDA Process Is Biased Against New TechnologyMobi Health News September 10, 2015
Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, authored an article in Mobi Health News titled “How the FDA Process Is Biased Against New Technology.”
Following is an excerpt:
To be fair to Congress, clearly our elected officials in 1976 were concerned about new technology and the unknown risks it might present. Further, simply as a matter of administrative functioning, Congress wanted to make sure that FDA was the gatekeeper and had the chance to say no to new technology that may present unacceptable risks. Congress couldn’t very well say that all new technology was automatically in class I, the lowest level of regulatory oversight, and let every new device go directly to market regardless of the risk it presented.
Unfortunately, though, despite best intentions, the system isn’t working. The system ends up discouraging innovative technology because changing the default class III determination for a new technology to a lower, more reasonable level is expensive and time-consuming. By starting a new technology off automatically in class III, the law plainly discourages new technology.